EDMONTON — Lochan Bakshi grew up saying many goodbyes, criss-crossing India with his family because his father was regularly transferred for his job on the railway cleaning locomotive boilers.

“It taught me how to say goodbye — and how to say hello every two years,” said Bakshi one week ago, an open, thoughtful man who warmly welcomed the Journal to witness his final decline. “Here was the chance to express my thoughts and so on about the dignity of dying.”

On Tuesday evening, Bakshi said his final goodbye, dying painlessly and peacefully at 87 in his sleep — except for his signature loud snoring, say friends who were by his side — having decided to stop kidney dialysis and quicken death without experiencing more pain in his feet from diabetic sores and the possibility of amputation.

In the end, Bakshi only missed one dialysis treatment on Monday. It’s unlikely the buildup of toxins in Bakshi’s blood caused his death. His body had been weakened by pneumonia, shortness of breath and congestive heart failure, all of which likely played a role.

“When he made the decision to stop dialysis, I believe he also lost his will to live,” said 51-year-old Ravi Bakshi, the youngest of Bakshi’s three sons. “He had resigned himself that this was coming.”

Yet Bakshi was outspoken on the need for the federal and provincial governments to debate euthanasia in Canada. He agreed with a landmark Quebec report released in March that said doctor-assisted euthanasia — rather than family-assisted suicide — be allowed in “exceptional circumstances” for those who are terminally ill.

It is currently illegal for doctors to help someone die, so only patients who can refuse ongoing treatment — dialysis, antibiotics, mechanical ventilation or artificial hydration and nutrition — can feel empowered to choose a different journey’s end.

That discrepancy, said Erin Nelson, a professor in the University of Alberta’s law faculty who specializes in health-care ethics, needs to be addressed through public debate.

Bakshi wanted to spark that debate by allowing the public, through the eyes of the Journal, to witness the results of his choice to refuse dialysis. For the last eight years, he spent four hours three times a week hooked up to a dialysis machine that cleaned his blood.

“I have got to go, but let me get some good out of it. If I can advance the cause of dignified death, then I have done something,” Bakshi said last week. “I want the maximum good that can come out of this.”

Friday was his last treatment in the dialysis clinic.

“It feels strange that this is the last time I’ll be here,” he said, as dirty blood pumped out through an artery and clean blood back in through a vein. “I feel like shaking hands with everybody, but I don’t think that would be appropriate.”

“I think I’m doing the right thing. I’m sure I’m doing the right thing,” Bakshi said. “I will just be sleeping more or less. Numbness, more than anything else. But there are thousands of people who have no option like me. They need a dignified farewell.”

Even nearing the end, Bakshi’s sense of humour, his easy chuckles and his recognition of the beauty of life — from the purple orchid blooming on the ledge of his hospital room to the ordinary dandelion soon to be pushing through Edmonton grass — was clearly evident.

Bakshi, a retired biology professor who worked at Athabasca University from 1973 to 1990, cared for the orchid with a thimble-full of water every day, plus a spritz to its leaves, since he was first admitted to hospital on Jan. 9 after two or three mini-strokes. As for the dandelions, Bakshi can identify each yellow bloom as female or male, neuter or bisexual, and knows they have adapted to lawn-mowing by curling up to hide from the blades.

“Adapt to your new circumstances,” Bakshi said philosophically.

That Friday, a long-awaited bed had became available for him in an assisted living facility, but Bakshi turned it down, determined not to languish there in pain but to instead cease dialysis while his mind was keen and sharp. He did not have a chance to finish last-minute academic work on wild flowers, nor to travel to the one place he wished, laughing at the thought.

“The place I want to go to is Machu Picchu, so you can see the problem, unless we travel all the way by presidential helicopter I won’t reach there,” he said.

Edmonton was his home base for 40 years, following a career of scientific research. Bakshi left India in 1954 for Washington State University as a Fulbright Scholar, to Saskatoon as a post-doctorate fellow, then Sierra Leone and the University of Ghana, on to Nelson, B.C., where he developed a bachelor’s degree program at Notre Dame University and finally to Edmonton, where he helped develop virtual teaching classes at Athabasca University.

“I know it is tough for everybody,” said Bakshi, four days before his death. He was hooked up to oxygen, his speech slowed by a shortness of breath. His feet were wrapped in bandages to protect the sores that grew one after the other, caused by Type 2 diabetes. But he had no time for naps; instead, using all the time in the world to share his life.

“For me to talk about my own funeral is not easy, but we have been managing that,” Bakshi said of his family. “I try not to bring out any tears when they are around, but it is tough.”

He tells the news to a colleague by phone, which he keeps close at hand on the hospital bed. Even until the end, he wore dress pants and a button-up shirt and shaved on a daily basis. A crocheted purple and blue afghan kept him warm.

“In seven to 10 days, I’ll be gone,” he explained to Robert Holmberg, who will be speaking at Bakshi’s funeral on Sunday. “I’ll still be alive for another week or so, but you are my best friend in the university so I thought I should let you know and you let the president’s office know.”

The end came faster than expected.

“(My body) is worsening,” he said. “It is not going to get better, obviously, and if it is not going to get better, than I should make conscious decisions about my future.”

One of the people he may miss the most is his ex-wife, with whom he was estranged for 20 years before becoming friends again. In more recent days, she brought him home-cooked Indian food to eat while in hospital. He loved food so much, he ate every meal as if it were his last, joke his family.

“We have come to understand each other more now than we did before,” Bakshi said. “I think we have fallen in love all over again. It is nothing sexual again. We just have come to realize the goodness in each other, so it is tough.”

Yet as death neared, he had no fear.

“At the age of 87, what are two more weeks worth? You see? They are nothing,” he said. “Here I am trying to show that there is some good in having a dignified death.”

Deepi Mehta, Bakshi’s niece from Houston, Texas, said “Uncle” wanted an interfaith funeral, mixing Catholic hymns, a Muslim cleric and a Sikh ceremony, including the reading of a poem by Rabindranath Tagore, a Bengali poet who won the Nobel Peace Prize in 1913.

“We didn’t say goodbye; we say we will meet again,” said 67-year-old Mehta, who, as a Sikh, believes in reincarnation and considered Bakshi her father figure after her own father died when she was 10.

Bakshi remained always the scientist, never quite sure of reincarnation or heaven, waffling, but open-minded, depending on whom he spoke with.

“Maybe there is life after death. No one has come back to tell us,” he said. “David Suzuki says it’s all chemicals physically, but about the soul, my religion says there is a soul. Sometimes, I’m on one side and sometimes I’m on the other.”

Son Ravi said his father’s scientific mind, fuelled by a library of 3,000 books, always challenged the status quo.

“The reason he became passionate about (the right to die) is because he’s a scientist,” Ravi said. “It went beyond religion. It went beyond ethics to ‘what’s humane. Why should someone suffer?’”

Bakshi was a fighter his entire life, having survived a stroke, an aneurysm and a car crash in which his neck was broken.

“He was very proud at the end of life to stir the pot,” Ravi said.

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THURSDAY, April 26 (HealthDay News) -- Racial disparities in kidney transplants for U.S. children have fallen since a new policy was introduced in 2005 by the United Network for Organ Sharing, researchers say.

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Novartis International AG / Novartis drug AfinitorR approved by FDA as first medication to treat patients with non-cancerous kidney tumors associated with TSC . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

• Kidney tumors affect up to 80% of patients with tuberous sclerosis complex (TSC) and growing tumors may lead to unpredictable life-threatening complications[1]
• Prior to the approval of Afinitor, surgical intervention was the only treatment option for patients with these kidney tumors associated with TSC[2],[3]
• Approval marks the second TSC-related indication for Afinitor in the US, where it is also approved to treatsubependymal giant cell astrocytoma (SEGA) in TSC[3]

Basel, April 26, 2012 -Novartis announced today that the US Food and Drug Administration (FDA) approved Afinitor^R (everolimus) tablets* for the treatment of adult patients with kidney tumors known as renal angiomyolipomas and tuberous sclerosis complex (TSC), who do not require immediate surgery[2]. This marks the first approval of a medical treatment in this patient population[2],[3].

The accelerated approval was based on the Phase III EXIST-2 (EXamining everolimus In a Study of TSC) trial, which found that 42% of patients on everolimus experienced an angiomyolipoma response versus 0% of patients in the placebo arm (p<0.0001)[2],[4]. The time to angiomyolipoma progression was also statistically significantly longer in patients on everolimus (p<0.0001). Among the 97% of trial patients with skin lesions, one of the key concerns for the majority of patients with TSC, a 26% response rate was seen with everolimus versus 0% with placebo (p=0.0011)[2],[5].

"Renal angiomyolipomas are one of the greatest causes of morbidity and mortality in adult TSC patients and can be one of the most challenging aspects of the disease to treat," said John Bissler, MD, Clark D. West Endowed Chair of Nephrology at Cincinnati Children's Hospital Medical Center. "Today marks an important step for the TSC community, as Afinitor is now the only approved medicine to reduce the kidney tumor burden in these patients."

Up to 80% of patients with TSC, a genetic disorder that may cause non-cancerous tumors to form in vital organs, will develop renal angiomyolipomas. Typical onset occurs between the ages of 15 and 30 and prevalence increases with age. Over time, these tumors may grow large enough to cause severe internal bleeding, require emergency surgical interventions, such as embolization and nephrectomy, or lead to kidney failure[1]. The tumors can be difficult to manage as they often form in both kidneys[5],[6]. In addition, skin lesions occur in more than 90% of patients with TSC[7]. They may develop in infancy, can become more prevalent with age and cause disfigurement[1],[5].

"With this FDA approval, Afinitor becomes the first medical option to treat two of the most debilitating manifestations of this challenging, lifelong disease - kidney tumors called renal angiomyolipomas and brain tumors known as SEGAs," said Hervé Hoppenot, President, Novartis Oncology. "This approval further strengthens our commitment to address unmet needs in TSC as we continue to research everolimus and mTOR inhibition across other manifestations of the disease."

Based on an effect on a clinical endpoint other than survival or irreversible morbidity, this indication was approved under the FDA's accelerated approval program, which provides patients access to a treatment for a serious or life-threatening illness and that provides meaningful therapeutic benefit to patients over existing treatments[2]. Novartis previously received approval for everolimus for the treatment of adult and pediatric patients, aged three or older, with subependymal giant cell astrocytoma (SEGA) associated with TSC who require therapeutic intervention but are not candidates for curative surgical resection in the US, and in more than 40 additional countries. Filings for renal angiomyolipoma are under way in multiple countries outside of the US.

Afinitor works by inhibiting mTOR, a protein implicated in many tumor-causing pathways[1],[8]. TSC is caused by defects in the TSC1 and/or TSC2 genes[1]. When these genes are defective, mTOR activity is increased, which can cause uncontrolled tumor cell growth and proliferation, blood vessel growth and altered cellular metabolism[8],[9]. According to preclinical studies, by inhibiting mTOR activity in this signaling pathway, everolimus reduces cell proliferation and blood vessel growth[1],[2].

Affecting approximately one to two million people worldwide, TSC can affect many different parts of the body, including the kidneys and brain, as well as the heart, lungs and skin. Tuberous sclerosis complex is associated with a variety of resulting disorders, including skin lesions, seizures, swelling in the brain (hydrocephalus), kidney failure, developmental delays and behavioral issues[1].

About EXIST-2
EXIST-2 is the first double-blind, randomized, placebo-controlled, international, multicenter Phase III study for the treatment of patients with renal angiomyolipoma associated with TSC[2],[4]. Trial patients (median age=31, range 18-61) were randomized 2:1 to receive either everolimus (n=79) or placebo (n=39) at a daily starting dose of 10 mg. By the cut-off of October 14, 2011, the median treatment duration in the double-blind period was 48 weeks in the everolimus arm and 45 weeks in the placebo arm[2].

In the study, 42% of patients on everolimus (33 of 79; 95% CI 30.8-53.4) experienced an angiomyolipoma response versus 0% on placebo (0 of 39; 95% CI 0.0-9.0)(p<0.0001), defined as a 50% or greater reduction in the sum of angiomyolipoma volume relative to baseline, the absence of new tumor growth at least 1 cm in longest diameter, absence of kidney volume increase of 20% or greater and no renal angiomyolipoma-related bleeding of Grade 2 or higher[2].

Everolimus demonstrated superiority to placebo for both supportive efficacy outcomes measured: time to angiomyolipoma progression and skin lesion response rate. There were three patients in the Afinitor arm and eight patients in the placebo arm with documented angiomyolipoma progression by central radiologic review. The time to angiomyolipoma progression was statistically significantly longer in patients on everolimus (p<0.0001; HR 0.08, 95% CI 0.02-0.37). Skin lesion response rate was significantly higher in the everolimus arm. A partial clinical response in skin lesions (corresponding to a 50% or greater improvement) was observed by Physician Global Assessment in 26% of patients on everolimus, compared with 0% of patients on placebo (p=0.0011). No complete responses were observed[2].

The most common adverse event (AE) in the everolimus arm (with an incidence of at least 30%) was stomatitis. The most common Grade 3-4 adverse reactions (incidence >= 2%) were stomatitis, amenorrhea and convulsion. The most common laboratory abnormalities (incidence >= 50%) were hypercholesterolemia, hypertriglyceridemia and anemia. The most common Grade 3-4 laboratory abnormality (incidence >= 3%) was hypophosphatemia. Adverse events observed in this study were for the most part consistent with the known safety profile of everolimus in the TSC setting[2].

About everolimus
Everolimus is now approved as Afinitor^R (everolimus) tablets in the United States (US) for the treatment of adult patients with renal angiomyolipomas and tuberous sclerosis complex (TSC), who do not require immediate surgery. The effectiveness of Afinitor in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. Further follow-up of patients is required to determine long-term outcomes. Everolimus is also approved in the European Union (EU) as Votubia^R (everolimus) tablets and in the US as Afinitorto treat adult and pediatric patients, aged three years or older, with SEGA associated with TSC who require therapeutic intervention but are not candidates or amenable for surgery. The effectiveness of everolimus is based on an analysis of change in SEGA volume in patients three years of age and older. Further clinical benefit has not been demonstrated.

Everolimus is approved as Afinitor in more than 80 countries including the US and throughout the EU in the adult oncology settings of advanced renal cell carcinoma following progression on or after vascular endothelial growth factor (VEGF)-targeted therapy in the EU and after failure of treatment with sunitinib or sorafenib in the US. Afinitor is approved for the treatment of locally advanced, metastatic or unresectable progressive neuroendocrine tumors of pancreatic origin in adults in the US and EU.

Everolimus is also available from Novartis for use in other non-oncology patient populations under the brand names Certican^R and Zortress^R and is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.

Indications vary by country and not all indications are available in every country.

Important safety information about Afinitor/Votubia
Afinitor/Votubia can cause serious side effects including lung or breathing problems, infections, and renal failure which can lead to death. Mouth ulcers and mouth sores are common side effects. Afinitor/Votubia can affect blood cell counts, kidney and liver function, and blood sugar and cholesterol levels. Afinitor/Votubia may cause fetal harm in pregnant women. Women taking Afinitor/Votubia should not breast feed.

The most common adverse drug reactions (incidence >=15%) are mouth ulcers, diarrhea, feeling weak or tired, skin problems (such as rash or acne), infections, nausea, swelling of extremities or other parts of the body, loss of appetite, headache, inflammation of lung tissue, abnormal taste, nose bleeds, inflammation of the lining of the digestive system, weight decreased and vomiting. The most common Grade 3-4 adverse drug reactions (incidence >=2%) are mouth ulcers, feeling tired, low white blood cells (a type of blood cell that fights infection), diarrhea, infections, inflammation of lung tissue, diabetes and amenorrhea. Cases of hepatitis B reactivation and blood clot in the lung and leg have been reported.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "commitment," "continue to," "under way," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Afinitor or regarding potential future revenues from Afinitor. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Afinitor to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Afinitor will be approved for any new indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Afinitor will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Afinitor could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2011, the Group's continuing operations achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion (USD 9.2 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Novartis Group companies employ approximately 124,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

*Known as VotubiaR (everolimus) tablets for certain patients with SEGA associated with TSC in the EU and Switzerland.

References
[1] National Institute of Neurological Disorders and Stroke. Tuberous Sclerosis Fact Sheet. Available at http://www.ninds.nih.gov/disorders/tuberous_sclerosis/detail_tuberous_sclerosis.htm. Accessed April 2012.
[2] Novartis data on file. http://www.pharma.us.novartis.com/product/pi/pdf/afinitor.pdf. Accessed April 2012.
[3] Ewalt D, et al. Long-term outcome of transcatheter embolization of renal angiomyolipomas due to tuberous sclerosis complex J of Urology 2005 ;174:1764-1766.
[4] US National Institutes of Health. Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolimpoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) (EXIST-2) Available at: http://clinicaltrials.gov/ct2/show/NCT00790400?term=NCT00790400&rank=1. Accessed April 2012.
[5] Roach S, et al. Diagnosis of Tuberous Sclerosis Complex. J Child Neurol. 2004 Sep;19(9):643-647
[6] Bissler J, et al. Perspectives in Renal Medicine Renal Angiomyolipomata Kidney International 2004; 66;924-34.
[7] Crino P, et al. The Tuberous Sclerosis Complex. N. Engl J Med. 2006 Sep;355(13):1345-56.
[8] Motzer, et al. Phase 3 Trial of Everolimus for Metastatic Renal Cell Carcinoma. Cancer 2010 Sep;116(18):4256-4265.
[9] Krueger D, et al. Everolimus for Subependymal Giant-Cell Astrocytomas in Tuberous Sclerosis. Engl J Med. 2010 Nov; 363(19): 1801-11.

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