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2009 10 31 globe and mail'What gives them the right to put a price on my life?'
Last spring, Ontario stopped paying for the use of more than one drug to battle
pulmonary arterial hypertension, a rare and incurable heart and lung disease. Today,
31-year-old Bonnie Cameron is in a Toronto hospital fighting to survive - a fate that
other patients fear also awaits them
JESSICA LEEDER 1869 Words Saturday, October 31, 2009 Page A10 All material copyright CTVglobemedia Publishing Inc. or its licensors. All rights reserved. Bonnie Cameron and Cindy Waters-Goodman do not know each other, but they have much in common. Both are feisty, small-town Ontarians who were young, busy mothers when hit with diagnoses of pulmonary arterial hypertension, an incurable heart and lung disease. Ms. Cameron's verdict came after the day she felt constantly winded and her legs grew so swollen that she had to scissor off her jeans. A family photographer, Ms. Waters-Goodman found out after a flight of stairs at work rendered her faint, dizzy and slurring her words. Both were started on a regimen of drugs that are costly but slowed the pace of the disease, which is uncommon and often goes undetected. The province paid much of the tab, which the women estimate was about $100,000 a year each. Their lives improved drastically: They could play with their kids, cook meals and shower without fainting. Then, last spring, out of the blue, both received letters informing them the province would no longer allow more than one medication. To continue receiving support, they'd have to stop taking combos. After much lobbying, Ms. Waters-Goodman won a reprieve and can stay on her combination of drugs for one more year. Ms. Cameron wasn't so lucky. Forced to give up her secondary medication, she has suffered greatly, and this week slipped into critical condition after being moved to hospital in Toronto. With an intravenous line in her neck and several failing organs, she seesaws between life and death. No one knows exactly how many Canadians suffer from pulmonary arterial hypertension (PAH). Estimates range from 2,000 to 10,000 people. While the disease cannot be cured, by experimenting with drug combinations, specialists around the world are finding they can keep patients alive twice as long as is possible without medication, sometimes more than 10 years. Ontario was one of several provinces to underwrite the cost of this therapy - until the practice was reviewed and letters went out informing patients and doctors there was a "lack of good quality safety and efficacy evidence" for the multidrug approach. And those able to secure funding for secondary medications on their own - through private insurance or by taking part in a drug trial - were told that this would nullify coverage of their primary medication. The decision, made by the province's Committee to Evaluate Drugs, alarmed patients and "There's no question that we cannot do as well in Ontario now for our patients as other places in Canada," said Dr. Sanjay Mehta, a PAH specialist in London. "This is a human issue. If someone is in front of you doing badly on the first drug, do you just sit and watch until they die?" DOCTORS WERE PUZZLED
It has been a decade since the bizarre ballooning of her legs and the feeling she was suffocating drove Bonnie Cameron to a small-town hospital in Hagersville, where puzzled emergency-room doctors sent her to specialists in nearby Hamilton. After a month of back-and-forth with more specialists in Toronto, her symptoms - dizziness, light-headedness, inability to catch her breath - were diagnosed as severe PAH. The bedridden 22-year-old had never heard of the disease, but its description made her other problems - man trouble, money trouble and raising a toddler by herself - pale in comparison. "The doctors more or less said I probably had a month to live," she recounted this week after arranging for a lawyer to update her will. "Now it's almost 10 years later. I'm still kicking." But her status has worsened since her doctor, Hamilton internist Clive Davis, weaned her off all but one medication. When she was diagnosed, Dr. Davis saw what he describes as a "dramatic improvement" in her condition when she began taking Flolan, the popular PAH drug that helps to open constricted blood vessels. A sensitive compound, it must be kept cool and is administered by a constant intravenous drip that requires patients to carry around a Walkman-sized pump along with a cassette of medication and an ice pack. Flolan is also expensive - a year's supply can cost around $100,000 a person. But Ms. Cameron was granted coverage under Ontario's Exceptional Access Program (EAP) and saw her disease status reduced from most serious to most manageable. "I was doing very, very well. I was actually feeling normal," she recalled. "I was able to go swimming with my daughter, ice skating . things that normal parents would do." After about four years, though, her body began to reject the IVs, a common problem. Dr. Davis switched her to a tandem of two oral medications: Bosentan, which can aid blood flow to the lungs, and Sildenafil, which expands blood vessels (a blue pill known as Viagra when used to treat erectile dysfunction). Compared with Flolan, this combo was "less than perfect," Dr. Davis said, "but still significantly better than nothing." The official in charge of provincial drug funding says none of this should have happened. Helen Stevenson is the deputy minister of Health and Long-Term Care in charge of EAP, which is open to people of limited means. This includes most PAH patients, who are often on social assistance because they are too ill to work. EAP covers five of the six medications currently used in Ontario to treat PAH, but Ms. Stevenson says policy has never been to underwrite more than one of them. Because "there's a lack of published evidence around the use of combination therapy," she explained, ". we have not been funding" it. The practice was approved in the past by accident, she added, likely because doctors were exploiting a loophole in the process. It was only this year that her case reviewers realized that many doctors applying to have funding for one PAH drug weren't disclosing the fact that a patient was already taking something else. Halting the payments sparked a litany of complaints, so Ms. Stevenson struck a special subcommittee to study the situation in detail. Patients currently in need of the therapy feel they can't wait. 'I WAS DYING'
Cindy Waters-Goodman says she is evidence that combination therapy works. "I am living proof," said the 39-year-old mother of two, as she restocked her Flolan cassette in the living room of her townhouse in Holland Landing, north of Toronto. Diagnosed two years ago, she found that one oral medication and then two seemed no match for her disease. "I felt I was dying," she said. "The distance from my bathroom upstairs to my bed is maybe four feet. I couldn't do that without having someone help me. . I was fainting all the time." Then her doctor, John Granton, added Flolan to her regimen, along with Sildenafil, which her private health insurance covered. "All of a sudden, I noticed a difference. I could walk to the bathroom myself." She kept improving, and "I'm thrilled now with how my life is. Don't get me wrong: I'm not normal. I'm limited. But I'm living now. I'm living." Then, in April, the province notified her it would not underwrite the Flolan if she kept taking Sildenafil. "It felt like . they were saying, 'We don't really want you to live any more,' " she said. Her doctor, family and friends barraged Ms. Stevenson's office with calls and letters, winning the reprieve "due to the life-threatening nature" of her condition. However, she says, "I'm coasting so well that I don't want to play around with my drugs in case I start declining. This is life-sustaining therapy." Her family may even move someplace where drug combinations are allowed. "We just want the same level of patient care they have in the other provinces. . They should not be second-guessing the doctors." When the province stopped paying for Bonnie Cameron's drugs, Dr. Davis wrote to Ms. Stevenson's office, but to no avail. "The government basically shoved her into right heart failure," he said. "I've been battling since then." The fight now is to keep Ms. Cameron alive to raise her 12-year-old daughter. She argues that she wouldn't have deteriorated so rapidly, if at all, had she not been forced to give up the Sildenafil, which costs about $60 a day. "I think it's ignorant," she said. "What gives them the right to put a price on my life?" Committees that decide drug funding consider many factors, said Arthur Schafer, director of the Centre for Professional and Applied Ethics at the University of Manitoba, but in the case of rare diseases, particularly if the science is thin, the process becomes more subjective and often controversial. "Patient groups are sometimes very upset by that," he said, "but some kind of rationing decision takes place in every health-care system." 'PULLBACK' FEARED
There is little research on PAH because the disease is so uncommon and deadly that studying treatments in randomized trials is difficult. Also, patients often respond differently to the same medications. To date, only a handful of valid trials of combination therapy have been conducted. The largest study, published last year in The Annals of Internal Medicine, showed encouraging results, and Dr. Mehta, medical director for the Pulmonary Hypertension Association of Canada, said the approach roughly doubles a patient's life expectancy after diagnosis. Common practice in Europe and the United States, combinations are generally allowed in Quebec, B.C. and Alberta - but "not necessarily because the people who fund drugs . have done an extensive review and support this approach," admitted a specialist, speaking on condition he not be identified in case his remarks spark "a pullback of medications." Officials, he said, have opted to be "supportive of pulmonary hypertension specialists in terms of allowing whatever would be most helpful for patients. This has been hugely advantageous." Doctors hope that Ms. Stevenson's subcommittee will agree to restore similar latitude in Ontario. But until a decision is made - perhaps in January - they're calling for flexibility when a convincing case can be made for combination therapy. "This is not a disease like heartburn or asthma," Dr. Mehta explained. "There's mortality every month in front of your eyes. You cannot afford to sit around and do nothing." Pulmonary arterial hypertension (PAH) is a disease that causes abnormally high pressure in the arteries that bring blood from the right ventricle (lower chamber) of the heart to the lungs. These pulmonary arteries may be scarred and become so narrow that the flow of blood is blocked. This reduction weakens the lungs' ability to transfer oxygen and forces the heart to work harder. Over time, as the right ventricle becomes strained, the heart muscle thickens and causes a backup of blood in the right atrium (upper chamber). Eventually the right ventricle weakens so much that it fails, eventually causing death. While there is no cure for PAH, advances in treatment have drastically slowed the onset of the disease, in some cases by as much as a decade. Source: Error! Hyperlink reference not valid. and the Pulmonary Hypertension Association
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Currículum Resumido Dra. Marcela Redruello Títulos Médico, otorgado por la Universidad de Buenos Aires el 22 de diciembre de 1989. Títulos de posgrado - Médico Especialista en Cardiología, recibida el 21 de diciembre de 1993 Otorgado por la Universidad Católica Argentina - Médico Especialista en Medicina Nuclear. Recibida en noviembre de 1998. Otorgado por la Universidad d