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PostPosted: Sat Apr 02, 2011 6:43 am 
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Australian pharma urges govt over clinical trials

Just 574 clinical trials were started in Australia in 2010, the lowest number since 2001 and 99 fewer than in 2009, say new government figures.

The number of new clinical trials in Australia has fallen by an average of 13% every year since 2007, and the new figures - contained within the Therapeutic Goods Administration's Half-Yearly Performance Report - show, first the first time ever, three consecutive annual falls in trial numbers and a 15% drop in the past year, according to industry group Medicines Australia.

"These are not the kinds of records we want to be setting," said Medicines Australia's chief executive Brand Shaw, who added that it is now "crunch time" for the industry. "The very future of Australia's A$1 billion clinical research industry is at stake - I don't think that is putting it too strongly," he said.

The government must deliver on the promise it made in early March to deliver by July the recommendations of the report presented to it in early March by the Clinical Trials Action Group, a panel established by the government with a remit to arrest the decline in clinical trial activity in Australia.

"The competition for R&D investment from countries in Asia and Europe is extremely fierce. Only with the right policy settings can we hope to grow our R&D industry and keep cutting-edge medical science in Australia," said Dr Shaw.

Clinical trials also save Australia's Pharmaceutical Benefits Scheme (PBS) A$100 million a year, "so the more clinical trials we conduct in Australia, the greater the saving for the taxpayer," he added.

In its report, the Action Group makes a range of recommendations aimed at: - improving the timeliness of ethics and research governance review; - providing for cost recovery of efficient clinical trials; - ensuring that trials can take advantage of the developing e-health system; - improving patient recruitment; - facilitating better national coordination and greater collaboration across clinical trials networks; and - progressing key clinical trial issues.

Welcoming these recommendations, Innovation Minister Kim Carr said that their adoption would be "an important microeconomic reform" that would "improve productivity and have benefits for patients, industry, researchers and governments."

"The industry estimates the annual economic worth of clinical trials to be in the order of A$450 million. Trials provide a significant number of high-skill, high-wage jobs for Australians," Senator Carr added.

http://www.pharmatimes.com/Article/11-0 ... rials.aspx

[comment - how do clinical trials save $100m a year when they have such a low success rate? Fewer quality trials would better than just more trials per se. I can see how failure to prove the efficacy of an existing drug could save money if its withdrawn, but new drugs tend to be getting more expensive not less]


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PostPosted: Thu Apr 07, 2011 11:52 am 
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Clinical Trials and Tribulations: The Future of Cancer Research

Medscape: Let's start with some background on clinical cancer research. What are the primary sources of funding for clinical cancer research?

Robert L. Comis, MD: There are 3 major sources of funding: the pharmaceutical industry, the government and, increasingly, not-for-profit foundations. But the 2 principle funding mechanisms are still the government and industry.

Roughly $150 million per year is allocated by the NCI to the cooperative groups to conduct clinical trials. These funds are expected to cover costs for all trials -- trials in kids and in adults, phase 2 and phase 3 trials, large randomized trials and smaller, less extensive trials. At the same time, however, a pharmaceutical company can pay $150 million for just 1 study. The level of funding is an order of magnitude different.

Medscape: If a physician is thinking about enrolling a patient in a clinical trial, what benefit would he or she have to enrolling in a trial that's run by a cooperative group?

Dr. Comis: In general, a few things might attract participating physicians to the group system. The trials sponsored by the cooperative groups tend to ask more scientifically generated questions rather than simply comparing drug A vs drug B. There is a broader portfolio of trials across the groups that include rarer tumors, for example. There is direct involvement of both academic and community doctors in the group system. Community doctors get to participate in the design of the studies and the execution of the trials, so the trials tend to focus on questions that are important to their practices, a bit beyond what might be asked by a pharmaceutical company.

Medscape: Is there a downside?

Dr. Comis: Yes, 1 downside is that the level of reimbursement for the research costs that are involved with placing one's patients into clinical trials is much lower than the actual cost for government-funded trials. It is important to point out that the cost for routine patient care, which is generally defined as care that would be covered for nonclinical trial costs, such as x-rays, laboratory work, office visits and the like, is generally covered by insurance. But research costs would likely include additional lab work or scans for the patient, and the data management and regulatory compliance that is required for the physician and their staff. The government reimburses the research costs at about $2000 per patient case, but we estimated several years ago that it cost a median of about $6000 per case.[2] This places a burden upon cancer centers, hospitals, and other institutions that participate in cooperative group studies to make up the difference; the physicians who are dedicated to putting their patients on trials end up donating their time and effort, and that of their staff, to do so. This lack of reimbursement is a key challenge nowadays considering the rising cost of medicine, in general.

Remember, physicians are not required to participate in medical research as part of their license to practice medicine. Their involvement in clinical research is completely voluntary to begin with, and then the need to donate their time, and also encourage cost-sharing on the part of their institution to participate in government-funded studies, creates a tremendous reliance for us on loyalty and volunteerism. There is a danger in being so reliant upon cost-sharing and volunteerism in the current healthcare environment wherephysicians and institutions are facing decreasing fiscal margins, which have been used in the past to support this effort.

Medscape: Aside from the financial disincentives, what are the other key drivers preventing physicians from participating, and what is preventing patients from enrolling in trials?

Dr. Comis: With regard to the patients, we've conducted 2 large national surveys and identified some fundamental issues.[3,4] One is that awareness of clinical trials as a treatment opportunity is quite low at the time of their diagnosis and before treatment decisions are made -- in the range of 10%-15%. So the vast majority of patients are never really aware that they might be able to participate in a clinical trial for their cancer treatment.

With regard to physicians, it takes additional time to get the patient in the study rather than simply giving them conventional treatment. Between additional staff time, additional physician time, and less reimbursement, there are both financial and practical forces working against enrollment.

There is considerable regulatory oversight associated with putting a patient in a trial. We carefully execute these studies and scrutinize how they're done on the practice level. So doctors who participate in clinical trials by the government or even by the pharmaceutical industry have to be willing to have people come in and actually audit their records. Thankfully, there is a cadre of physicians who are voluntarily committed and willing to do this, but we are also aware that this might be a disincentive for others.

Medscape: One of the issues raised in the IOM report was the flattening of research funding over the years. What effect do you see this having on clinical cancer research moving forward?

Dr. Comis: If you go back to the late 1990s, there was a substantial infusion that occurred at around the time of the doubling of the National Institues of Health (NIH) budget, which raised cooperative group funding from about $90 or so million to $160 million. It peaked in 2002 or 2003 and, since then, it's either been flat or decreasing.

As the IOM report presented, the cooperative group system is important for the patients and the country, and it should be supported at higher levels of federal funding. The cooperative groups are advocating for this as well, so that we can maintain a robust portfolio of trials that is large enough in number to have options available for patients across the many disease types and stages. Continued flattening in funding may lead to fewer trial opportunities for patients, which is a bit disconcerting to think about since we've always encouraged patients to participate in studies. The NCI currently has a budget of around $5 billion. Within the current national spending constraints, in general, I think everyone is very concerned that the NIH and NCI will experience cutbacks, along with many other federal agencies. In this environment, the only other option left to support increased funding for clinical research is some reallocation of NCI's existing budget.

Efficiency is also important. We realize that the current clinical trials system needs to become more efficient, and there has been a lot of emphasis and attention placed on this recently, with some success.

Medscape: If NCI were to reallocate funds, what would you see as the best way to use those additional funds to help the cooperative groups move cancer research forward?

Dr. Comis: There must be an increase in the research-related case reimbursement level to bring it in line with the actual costs to do the work. Beyond that, I would like to see us enhance the system and make it more attractive to do cutting edge studies that focus on the use of biomarkers and various techniques to identify selected groups of patients who are most likely to benefit from the new approach. The cooperative groups have the capacity to do this now. ECOG just coordinated TAILORx or PAACT-1,[5] the largest study in breast cancer ever conducted that was driven by cancer gene-based markers. It enrolled 10,000 women, and we evaluated their genetic markers and designed their treatment plan depending on those markers. ECOG's trial in stage II colon cancer (E5202) looked at 2 molecular markers before assigning the patient to a study arm.[6]

Trials are becoming more complex and expensive. As we continue to use molecular markers and design trials based upon what happens to those markers, there will have to be additional resources committed to doing the laboratory work and/or the imaging work required to answer the scientific question. We have to integrate biomarker laboratories and imaging programs into our normal workflow. We'll need to have core laboratory and imaging functionality built into the structure so that we can tap into it.

Another key piece would be a group-wide information technology system. The government is going to have to provide the common technology structure that works with our current systems.

The same is true for tissue acquisition and procurement. Across the groups, there are several large tissue banks that have the best clinically annotated specimens available. We see the need for the government to support harmonization of information technology around our banks, so that we can broaden access by more researchers across the country and throughout the world.

Medscape: What about regulations within and outside of the United States?

Dr. Comis: We have to address the tremendous regulatory burden associated with running clinical trials -- we estimate that $0.35 of every dollar goes toward the regulatory burden in some way.We're regulated by the NCI, by the US Food and Drug Administration (FDA), by the Office of Human Research Protect (OHRP). Although Centers for Medicare & Medicaid Services isn't directly involved, their regulations affect us because the clinical care costs of our elderly patients have to be coordinated with them.

This regulatory burden also affects our position as the research engine for the world. In general, the majority of patients who are on phase 3 pharmaceutical studies are outside of the United States because of the regulatory burden that we have in this country. It's easier for us to tack on to a study in Europe than it is for the Europeans to work with us, partly because OHRP guidelines require that their patient safety laws be virtually the same as ours. It doesn't make a lot of sense that we can't work with countries like Germany and France in a very easy way.

As we learned working with the epidermal growth factor receptor inhibitors, there are clearly genetic differences in different ethnicities. With the development of smaller subsets of disease based on various molecular and genetic characteristics, we need international cooperation. So, somehow our government will have to loosen up a little bit and make it easier for us to cooperate with our international colleagues.

Medscape: How optimistic are you about the future of the cooperative group system and clinical cancer research?

Dr. Comis: I am very optimistic. The IOM report made it clear that everything has to change, not just the groups but all stakeholders. The NCI has to change, the NIH has to change, the OHRP has to change, and the FDA has to change. We're all committed to change and are willing to change, but it has to be all for the better and it has to be fast. We're already having discussions with the NCI, and the discussions to date have been positive It's just the beginning. There's much more work still to look forward to.

http://www.medscape.com/viewarticle/740152


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PostPosted: Sat Apr 16, 2011 8:35 am 
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Yes, run for a cure -but what about preventing cancer?

We are asked to give generously to every cancer cause -and do, often in the hope that the disease won't touch us. But when cancer strikes your family or friends you soon find out how primitive the tools are to detect and treat it. And the commitment to prevention seems secondary.

Last year 174,000 Canadians heard the dreaded words, "You have cancer." More than 76,000 lost their lives to this chronic disease. It is expected that nearly half of all males and four in ten females will eventually contract cancer. One in four of us will die from it.

The lives of those who have been diagnosed are changed forever. It becomes a life of trying to defy the odds. The emotional, physical and financial strain on them and their families is profound and unyielding.

Countless billions have been spent in this country over the last half century on cancer screening, treatment and research. Last year cancer accounted for about 10% of our total health care spending - nearly $20-billion.

According to the Canadian Cancer Society the average cost of a single course of treatment is $65,000 -almost as much as our average annual household income.

The results? Not particularly impressive. The self-perpetuating cancer industry seems to be doing all right. But what about the rest of us?

A 2009 Conference Board of Canada study found that 180 Canadians for every 100,000 died of cancer in 1960. Fifty years later the much-trumpeted "War on Cancer" has only managed to reduce this mortality rate by about 5%. The elusive "cure" for cancer has been "just around the corner" for decades. And it is still out of sight.

We remain dependent on the same three primary treatments that have been used for generations: surgery to remove the tumour, chemotherapy and radiation to try to kill any remaining cancer cells. Anyone who has gone through this torturous "treatment" knows how medieval it can be.

Months of injecting a cocktail of drugs into your system, which kills both healthy and cancerous cells, followed by a period of intense radiation are still the basic responses. But both these treatments can have debilitating side effects, both short and long-term.

Fortunately there is an army of medical professionals and volunteers in cancer agencies and hospitals who are caring and dedicated. They work hard and optimistically to lessen the physical and psychological burden of these brutal treatments. And there has been progress with cancer drugs and procedures to make them more targeted and tolerable.

As for a cure for cancer -a silver bullet that will stop the suffering and deaths -don't count on that happening any time soon, if ever.

Leading researchers like Dr. Bert Vogelstein of the Howard Hughes Medical Institute believe, "it is going to be even more difficult perhaps than previously expected to derive real cures from such (drug) therapies." He suggests that redirecting research funds into detection and prevention would be a more sensible strategy.

A much greater emphasis on aggressive prevention is a common theme with critics of the current cancer strategy. They maintain that "Prevention is the Cure." It is widely acknowledged that over half of all cancers can be prevented -stopped before they start. But the present allocation of funds makes it clear that the cancer establishment isn't buying into the old axiom about 'an ounce of prevention.'

According to the Canadian Cancer Research Alliance less than 2% of the billions spent on cancer research in this country go to primary prevention. And yet, where cancer rates have dropped, there is a clear connection to prevention. Anti-smoking campaigns helped lower cancer rates for men. Reduced use of hormone replacement therapy did the same thing for breast cancer.

We all know the major lifestyle choices that contribute to cancer: smoking, obesity, inactivity, poor nutrition, and sun and radiation exposure. It's often within our own personal power to manage these risks.

However, viewed more broadly, cancer is an environmental disease. It is becoming increasingly apparent that the air we breathe, the water we drink, the food we eat, and the products we use contain a wide range of cancer-causing substances -pesticides, solvents, phthalates, heavy metals, hormones, and others.

Dr. Devra Davis of the University of Pittsburgh Cancer Institute is a strong believer in prevention. She maintains that there have been millions of preventable cancer deaths in the U.S. over the last 30 years. She attributes them to "an obsessive, militaristic focus on beating the disease," rather than removing carcinogens from our environment.

Of the hundred-plus cancer organizations in Canada, only a few focus primarily on prevention. None of them have much influence, or are among the big players.

We need advocacy that isn't afraid to take on foot-dragging governments and conflicting commercial interests. We need an alliance capable of rallying the public behind the knowledge we already have, to bring prevention to the forefront of the fight against cancer.

R. Michael Warren is a former private health care sector executive, Ontario deputy minister, Toronto Transit Commission chief general manager, and Canada Post Corporation CEO.

http://www.chathamdailynews.ca/ArticleD ... ?e=3075984


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PostPosted: Tue Apr 19, 2011 4:16 pm 
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Doctors find cancer research gaps

Australian doctors say a study has revealed serious gaps in cancer research, with relatively few clinical trials targeting four of the most serious types of cancer.

Out of 386 recent interventional cancer trials open for recruitment in Australia, only 24 focused on lung cancer, despite it being one of the deadliest variants, the study found.

The research by University of Sydney medical oncologist Rachel Dear and co-authors also found relatively few trials were being readied for colourectal, prostate and pancreatic cancers, three other lethal forms of the disease.

Breast cancer accounted for 62 of the trials.

Dr Dear used data from the Australian New Zealand Clinical Trials Registry to explore the number and types of cancer clinical trial activity.

The research also examined the association between cancer trials and sponsorship sources.

"We found that the number of trials for each cancer type did not always match the burden of disease caused by that cancer, thereby identifying gaps in cancer research," Dr Dear said.

Her research is published in the Medical Journal of Australia.

Professor Ian Olver, of the Cancer Council of Australia, wrote an accompanying editorial.

In it he said the results of Dr Dear's research reflected the international situation, where investment in trials for specific cancer types did not correlate with their disease burden.

http://news.smh.com.au/breaking-news-na ... 1djcj.html


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PostPosted: Wed Apr 20, 2011 7:35 am 
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Cancer trials do not reflect disease burden, Australian researchers find

Clinical trials in Australia are neglecting cancer types responsible for the heaviest burden of disease in the category, suggests an analysis of data from the Australian New Zealand Clinical Trials Registry (ANZCTR) and the US-based registry ClinicalTrials.gov.

A University of Sydney team led by Dr Rachel Dear, medical oncologist at the Centre for Medical Psychology and Evidence-based Decision-making, sought to map out current clinical trial activity in Australia by extracting data from the ANZCTR and Clinical Trials.gov on interventional trials for cancer that were recruiting patients as of 31 March 2009.

Specifically, the researchers wanted to explore whether trial activity in Australia reflected the burden of disease for cancer and whether it might be associated with different sponsorship sources. Their findings were published in the Australian Medical Association’s Medical Journal of Australia.

Clinical trials were described in terms of cancer type; the intervention tested; sponsorship and funding source; phase and design (randomised versus non-randomised); characteristics of the enrolled subjects; trial registry (the ANZCTR or CT.gov); and location of recruitment (Australia only or Australia and overseas).

Dear et al also obtained for each cancer covered data on disability-adjusted life-years (DALYs) for 2003. These represent the sum of the years of life lost due to premature mortality in the population and the equivalent ‘healthy’ years lost due to disability for incident cases.

The researchers then examined whether the number of clinical trials for each cancer in the analysis was proportionate to the number of DALYs for that cancer.

Breast cancer emphasis

The analysis identified 368 cancer trials that were recruiting in Australia as of 31 March 2009. Among these, 131 trials (36%) were registered with the ANZCTR and 237 trials (64%) with CT.gov. Randomised controlled trials accounted for 57% of the total.

Breast cancer was far and away the most represented disease type in the trial sample, with 62 interventional trials (17% of the total) open for recruitment, followed by lymphoma, leukaemia or all/multiple cancers (31 trials apiece), lung cancer (24), colorectal and brain cancer (21 each) and melanoma (17).

In terms of DALYS, though, breast cancer ranked only third in the sample, lymphoma sixth and leukaemia eighth. The heaviest burden of disease was for lung cancer, which ranked only fifth in terms of the number of trials underway in Australia, followed by colorectal cancer (sixth by number of trials).

Influence on sponsorship

Industry sources were the primary sponsor in 43% of the trials, Dear et al reported. Industry sponsorship was more likely for randomised controlled trials investigating systemic interventions (i.e., drugs or biological agents) in patients with advanced disease than it was for non-randomised trials of local therapies in patients with early disease.

The picture was different, though, for breast cancer, where most trials included women with early-stage disease and a large proportion were investigating non-drug interventions. Moreover, a higher proportion of breast cancer trials were non-industry sponsored and funded, which the researchers suggested “might be a consequence of consumer influence on the research agenda”.

While there was strong evidence overall that intervention type, cancer extent and allocation to intervention were related to sponsorship by industry after allowing for cancer type, the researchers were surprised to discover that cancer type was not significantly associated with industry sponsorship. The type of treatment rather than the type of cancer was more strongly associated with industry sponsorship.

Gaps in activity

“Cancers causing the greatest burden of disease in Australia are underrepresented in recruiting trials, revealing gaps in current research activity,” the researchers commented. “Industry sponsorship is associated with supporting randomised controlled trials of systemic therapies that include patients with advanced cancer but not with cancer type.”

The analysis of data from the ANZCTR and ClinicalTrials.gov “raises concerns about the direction of the research agenda and may be useful when designing and funding future cancer clinical trials”, Dear et al suggested. “Clinical trial registries are a largely untapped resource to describe the clinical trial research landscape and guide future trial activity.”

http://www.pharmatimes.com/Article/11-0 ... _find.aspx


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PostPosted: Fri Apr 22, 2011 5:09 pm 
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Immortality of all cancer cells exposed as a myth

Far from being immortal, most cancer cells seem unable to multiply limitlessly and spread throughout the body.

Dot Bennett of St George's University of London and colleagues found that only four of 37 skin cancer samples they examined displayed the supposed hallmark of cancer. "We thought they'd all be immortal, but they weren't," she says.

By studying the molecular profiles of the cancer cells as they grew in the lab, the team found that many appeared to have hit a "telomere crisis" and stopped dividing. Telomeres are the caps that protect the ends of chromosomes and they shorten every time a cell divides. In a telomere crisis, the tips become so short that the cell mistakes them for DNA breaks and tries to repair them, generating freak cells that die or become dormant.

The team found that the few cancer cells that are immortal activate telomerase reverse transcriptase (TERT), a part of the telomerase enzyme that rebuilds telomeres so they avoid a telomere crisis.

Normally, TERT is active only in sperm or egg cells, so looking for it in a tumour could tell doctors whether the cells are immortal and more likely to spread, helping them decide on the best treatment.

http://www.newscientist.com/article/dn2 ... -myth.html


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PostPosted: Sun Apr 24, 2011 8:12 am 
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Cancer clinical trials advance science and benefit patients

MASON CITY — Breast cancer patient Linda Anderegg was undecided about whether to participate in a cancer clinical trial until she got to thinking about her great-nieces.

“I had to do it for them,” she said.

Anderegg of Mason City agreed to participate in a clinical trial in 2004-05 for a new chemotherapy procedure. It ran for six months.

She also participated in a clinical trial of a drug to keep the cancer from recurring, testing a medication called Letrozole. This clinical trial was conducted over a five-year period, ending in December 2010.

Now cancer-free, Anderegg said, “I feel great.”

Clinical trials are research studies in which cancer patients voluntarily try out new medicines and procedures that may become the standard of care for cancer diagnosis, treatment or prevention, said Dr. Arvind Vemula, oncologist with the Mercy Cancer Center.

“It’s an opportunity to advance science and benefit patients,” he said.

The Cancer Center has participated in clinical trials since it opened in 1991, Vemula said. “We’re always on the hunt for better therapies.”

There are two types of clinical trials: observational and interventional.

An observational trial involves physicians watching patients undergo a particular treatment to a predefined outcome.

Interventional trials provide that physicians actively treat their patients using a new medication or procedure.

Of 50 clinical trials currently being conducted at the Mercy Cancer Center, 40 are interventional, Vemula said. A total 150 patients are enrolled in the 50 trials.

The clinical trials cover all types of cancer, but most involve treatments for breast, colon and lung cancer, the most common cancers treated at Mercy Cancer Center.

Not all cancer patients are eligible to participate.

Patients must not have more than one cancer or other disease that would make it difficult to tolerate the experimental drugs, Vemula said.

Anderegg is among the 20 percent of patients eligible for the cancer clinical trials who agree to participate.

Among the drugs tested in clinical trials within the past 10 years are Letrozole and Herceptin, both used in the treatment of breast cancer, and Avastin, which is used to treat a certain type of brain tumor as well as cancers of the kidney, lung, colon and rectum.

All have been approved by the Food and Drug Administration and are now used in the treatment of cancer.

Vemula recommends cancer patients inquire about clinical trials and whether any of the clinical trials may be right for them.

“It’s the only way (cancer treatment) can advance,” he said.

http://www.globegazette.com/news/local/ ... 03286.html


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PostPosted: Sun Jun 12, 2011 7:15 am 
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Obesity epidemic a hazard for kids

WHEN Byron kept gaining weight as a child, reaching 62kg by the time he was 10, his parents couldn't work out why.

When Byron started complaining of being thirsty all the time, his GP sent him to the Children's Hospital at Westmead in Sydney, where they discovered he had insulin resistance, a precursor to type 2 diabetes.

His parents were given two choices: put their son on medication and try to help him lose weight themselves - which they had already tried, with limited success - or take part in a weight-management trial at the hospital.

"My husband and I looked at each other and said, 'We know what we have to do for our child, let's just do the program'," Byron's mother Louise says.

The entire family, from NSW's Central Coast, had to change their eating habits. That's not easy for anyone to accomplish, let alone which are hard to break for anyone especially for a young boy.

"He's 10, 11 years old going through this, watching all his friends go to school with packets of chips and all the naughty things that he now can't have," Louise remembers.

The family got a structured meal plan: options for three meals and three snacks each day.

By the end of the 12-month study, Byron had reached his ideal weight of 45kg.

Preliminary results of the randomised controlled trial were presented to the Dietitians Association of Australia national conference in Adelaide last month. Research dietitian Megan Dunkley says the findings showed structured meal plans plus an exercise program improved the participants' insulin resistance in all 62 of the 10 to 17-year-olds.

Structured meal plans aren't a common intervention for children, as they're fairly strict and may seem "a bit cruel", says Dunkley. But with one in four Australian children overweight or obese, health professionals are treating a growing number of children for obesity-related complications.

Obesity prevention measures alone aren't enough, says Sarah Garnett, a clinical research fellow in pediatrics and child health at the Children's Hospital. "Prevention is vital, but we can't turn a blind eye to children who are already overweight or obese. There need to be very active treatment programs for them."

Many of the children who come to the hospital's weight management clinic already have co-morbidities of obesity, such as insulin resistance, high blood pressure, sleep apnoea, fatty liver or joint problems - diseases that were once the domain of much older people.

"Previously if a child was overweight or obese ... often nobody used to want to know them if they had some of the complications," says Garnett. She says the clinic helps children get their insulin resistance under control before it develops into type 2 diabetes.

But one of the biggest hurdles they face is the attitude among both the community and health professionals that weight loss is all too hard, despite the clinic's success, Garnett adds.

Multidisciplinary weight management services for Australian children and adolescents are few and far between, says Shirley Alexander, the hospital's staff specialist responsible for the weight management service.

She says the children arriving at the clinic are "just the tip of the iceberg".

Further, even health professionals are bad at judging a child's weight by sight alone, says Alexander, who calls for more involvement by GPs and pediatricians, who could measure children's weight and height, plot their body mass index and delicately raise the issue.

She adds: "The research in relation to smoking suggests that even if you bring up the topic, something is more likely to be done than if you ignore it completely."

Research by Melinda White, clinical leader, dietetics, at the Royal Children's Hospital in Brisbane, highlights the additional risk extra weight can pose during cancer treatment.

In the first international study of its kind, she found that if a child is overweight before having a bone marrow transplant, they're less likely to survive.

She defines overweight as 110 per cent of ideal body weight: "We're not talking about children who are morbidly obese. We're just talking about children who are even slightly overweight."

The reason for the link isn't clear, but White suggests it could be due to the distribution of chemotherapy drugs throughout the body tissues, or perhaps is caused by other, more complex, metabolic processes.

Regardless, the study - presented at last month's conference highlights the importance of helping overweight children lose weight before transplants.

Experts agree that parental involvement is crucial to helping children lose weight, particularly for pre-adolescents.

But Kerith Duncanson, a community nutritionist for Hunter New England Area Health Service in NSW, found a lack of awareness among parents about their children's weight status when she surveyed parents of an average, healthy group of children about their children's dietary habits, asking them how they perceived their child's weight.

Out of 147 parents, 146 believed their child's weight was average or lower, in contrast with national statistics.

"Do we have to show parents in the longer term what the consequences are of poor child nutrition in the absence of any health problems?" Duncanson asks.

"Will that motivate them to change?"

Even when parents get the message, as Byron's mother Louise did, she admits they need help, pointing to the importance of enrolling her son in the trial: "He'd still be that size and probably have diabetes by now if we didn't go through it."

http://www.theaustralian.com.au/news/he ... 6072635990


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PostPosted: Mon Jun 13, 2011 8:45 am 
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Breast cancer trial hailed as big leap

MILLIONS of women facing an elevated risk for breast cancer could slash their chances of getting the widely feared malignancy by taking a hormone-blocking pill used to treat the disease or prevent a recurrence, researchers say.

A compound known as an aromatase inhibitor cuts the breast cancer risk by 65 per cent for women prone to the disease for any reason, such as having risky genes, a relative who had the disease or being older than age 60, a long-awaited international study of more than 4500 women has concluded.

The results mark a highly anticipated advance towards the elusive goal of offering women the first safe way to protect themselves from a leading cancer killer. Women have long been able to take an older class of anti-estrogen drugs to reduce their risk, but few do because of possible side effects, including uterine cancer and life-threatening blood clots. Many experts had hoped aromatase inhibitors would offer a safer, more acceptable alternative. The new study was the first time one had been tested.

''This is a major step forward,'' Larry Norton, a breast cancer expert at Memorial Sloan-Kettering Cancer Centre in New York who was not involved in the research, wrote in an email. ''This is a long-awaited report from [among] the most highly-respected investigators in the field concerning a critically important topic in cancer prevention.''

Some breast cancer patient advocates and other experts, however, remained cautious. A 65 per cent reduction in risk is significant, but the absolute risk for these women remains small. Although aromatase inhibitors do not appear to cause uterine cancer or blood clots, the long-term safety of medicating women for many years remains far from clear, some experts say.

''This intervention offers women perhaps a more palatable option,'' said Andrew Seidman, a breast cancer expert speaking on behalf of the American Society for Clinical Oncology. The findings were posted online by The New England Journal of Medicine, which also offered a strongly worded editorial endorsing the results. ''It's a significant development,'' Dr Seidman said.

In the study, 4560 women in the US, Canada, Spain and France daily took 25 milligrams of Aromasin, which is known generically as exemestane, or a placebo. All the women were considered in danger of getting breast cancer because they were at least 60, had a close relative who had the disease, or scored high on a commonly used risk assessment scale. The study was partially funded by Pfizer, which makes exemestane, but conducted independently by the Canadian Cancer Society's NCIC Clinical Trials Group.

http://www.smh.com.au/lifestyle/wellbei ... 1fnem.html


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PostPosted: Tue Jun 14, 2011 10:47 am 
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Complication from spinal product omitted from studies, reasearches have financial ties to product's producer

(NaturalNews) In a study released Wednesday, a Stanford University surgeon said that one of Medtronic's best-selling spinal products can cause a condition which results in male sterility. The finding contradicts earlier research by doctors with financial ties to Medtronic, who did not find a connection between Infuse, the spinal product, and sterility. (http://www.nytimes.com/2011/05/25/b...)

According to a study, men treated with Medtronic's Infuse product during spine surgery were more likely to develop a particular infertility problem than those who did not get the product. Editorials questioned why the issue was not examined more in the Medtronic-funded studies.

The Stanford surgeon, Dr. Eugene J. Carragee, said he decided to study Infuse based on a complaint he received from an orthopedic surgeon. Dr. Tomislav Smoljanovic of Croatia, stated some problems with the product in an article related to the product.

Smoljanovic noted that, while identifying that six men in the Meditronic-sponsored study had developed the sterility-related condition, the researchers had not identified how many of those men had received Infuse as opposed to the bone graft used in a standard procedure.

Carragee's deeper look at the original study led him to question why the researchers had not broken out the patients in their study into those who received Infuse and those who did not, which, he said, is the standard way to present clinical trial results.

Thomas Zdeblick, a participant in the key Medtronic-funded study and director of the University of Wisconsin Spine Center, said there was no attempt to hide data on this issue from the original trial, but rather, there weren't enough numbers to reach statistical significance, "and the issue was left without a conclusion." (http://www.foxnews.com/health/2011/...)

Carragee said that among the 69 men he treated with Infuse, 7.2 percent suffered from retrograde ejaculation compared to less than 1% of the 174 patients who did not get the product. Carragee said that he and his colleagues posted their study online, ahead of the print version, because of these public health implications.

"In my opinion, it is important that men who are considering having children have the opportunity to weigh the risks of the various available procedures so that they can make their best-informed decision," Carragee said in a press release from the North American Spine Society, which is the association for spinal surgeons that publishes the medical journal.

The new study will likely further inflame the debate over whether industry-financed researchers present their findings in ways that benefit their corporate sponsors.

Six of the Medtronic study co-authors received a total of more than $6 million in various royalties from Medtronic, although none of the royalties were for Infuse. (http://www.jsonline.com/features/he...)

The Milwaukee Journal Sentinel released the following records from a public registry of physician payments maintained by Medtronic:

Ken Burkus, a Columbus, Ga., surgeon, and his RBCK Research & Consulting received $782,000 in various royalty payments from Medtronic in 2010. He is a co-author of all four of the papers on Infuse.

Thomas A. Zdeblick, a University of Wisconsin School of Medicine and Public Health orthopedic surgeon who, along with Taz Consulting, has received more than $23million in various royalty payments from Medtronic since 2002, was co-author of three of the papers. He is also the editor-in-chief of the journal where two of the papers were published.

Matthew Gornet, a St. Louis surgeon, and Gornet Enterprises got $755,000 in royalty payments last year.

Rick Sasso, an orthopedic surgeon with the Indiana Spine Group and co-author of one of the papers, got $2.7 million in various royalties from Medtronic last year.

Thomas Kleeman, a New Hampshire surgeon, co-authored one of the papers. He received between $106,000 and $111,000 in royalties and other payments last year.

Curtis Dickman, a Phoenix surgeon, co-authored one of the papers. Dickman and his Vantage Investments LLC got $389,000 in royalties last year.

http://www.naturalnews.com/032688_Medtr ... ility.html


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PostPosted: Wed Jun 15, 2011 9:34 am 
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$8m boost for WA health and medical research

THE State Government will set up a body to oversee an additional $8 million investment into health and medical research.

Health Minister Kim Hames said the funding boost would be good for health as well as the State economy, with every dollar of research adding between $2.40 to $3.56 to gross economic growth.

“This investment of an additional $8million over three years will support the launch of this revitalised and strengthened State Government’s commitment to health and medical research in WA,” he said.

“There will be additional investment in infrastructure and support for institutions to better assist our world-leading research institutes.

“We will increase our support for research projects that look at the best way to deliver health services, further supporting research that aims to increase efficiencies and improve patient outcomes.”

Funding will also be provided for more research fellowships to encourage research as a career.

The Government will model the body on the British-based The King’s Fund – a world leading not-for-profit organisation that works with individuals and organisations to shape policy and transform health services, supported by expert research and analysis.

http://www.perthnow.com.au/business/m-b ... 6075434413


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PostPosted: Fri Jun 17, 2011 8:03 am 
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New Zealand cancer drug to commence clinical trials

A novel cancer drug designed by scientists from The University of Auckland and Maurice Wilkins Centre for Molecular Biodiscovery, and licensed to university spin-out company Pathway Therapeutics, Inc., has received approval from the US Food and Drug Administration to enter clinical trials. Pathway Therapeutics has also secured an additional US $7.5 million in investment to undertake the Phase I clinical trials.

The drug, PWT33597, is a dual inhibitor of phosphatidylinositol-3-kinase (PI3K) alpha and mTOR, two key molecules implicated in cancer. It is the first agent with this biological profile to enter the clinic. Initially, a Phase I trial will evaluate the safety of escalating doses of PWT33597 in patients with advanced solid tumours.

Medicinal chemist Professor Bill Denny and cell signalling expert Professor Peter Shepherd, both of The University of Auckland and Maurice Wilkins Centre for Molecular Biodiscovery, established Pathway Therapeutics in New Zealand in 2008 to develop inhibitors of PI3K to treat cancer. The company’s development was guided by Auckland UniServices Ltd and benefited from a significant investment from the Breast Cancer Research Trust. The company has now moved to San Francisco but still has a significant level of New Zealand shareholding.

The PI3K drug discovery programme originated from research funded by the Health Research Council of New Zealand and the Maurice Wilkins Centre, which brought together Professors Denny and Shepherd and their research teams from the Auckland Cancer Society Research Centre and the Signal Transduction Laboratory, respectively. The Maurice Wilkins Centre also facilitated their research by providing long-term salary support of key scientists in the PI3K inhibitor programme and providing infrastructure critical for developing the drugs.

“The announcement that PWT33597 will proceed to clinical trials is a significant milestone for the PI3K inhibitor programme established in New Zealand,” says Professor Rod Dunbar, Director of the Maurice Wilkins Centre. “It is an indication of the strength of drug discovery in this country and the standing of New Zealand science on the international stage. It is also a very tangible example of the value of interdisciplinary collaboration in tackling complex scientific problems.”

“Developing drugs to block PI3K is a ‘hot topic’ in international cancer research. Mutations in PI3K alpha are some of the most common genetic abnormalities in human cancers, especially breast, ovarian and colon cancers,” explains Professor Shepherd “Because of this it is thought that PI3K inhibitors will be potentially effective against a wide range of tumour types and have the potential to be “blockbuster” drugs.”

“Our novel drug, PWT33597, inhibits not only PI3K alpha but also mTOR, one of the most important molecules activated by PI3K,” says Professor Denny. “Inhibiting the activity of both proteins provides a back-up should cancer cells find a way to overcome either one of the blockades. Our preclinical research has shown that PWT33597 very effectively inhibits the critical signalling pathway that these two molecules regulate.”

http://www.healthcanal.com/cancers/1796 ... rials.html


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PostPosted: Sat Jun 18, 2011 7:42 am 
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Cancer drug guinea pigs: Poor women

A clinical research laboratory was raided by officials of the Andhra Pradesh state government on Friday for allegedly conducting clinical trials of a breast cancer drug on nearly 30 agriculture labourers. The premises of Axis Clinical Research Organisation’s laboratory in Miyapur, Hyderabad were raided and two other women, who allegedly introduced the women to the laboratory, have been arrested.

The laboratory conducted tests and research in keeping with the requirement of pharma companies. “The employees who were present in the lab at the time of the raid have admitted to conducting clinical trials on two of the women,” said State Medical and Health Minister Dr DL Ravindra.

The women, who are undergoing treatment at the district headquarters hospital, are out of danger, he said.

“The company should have conducted tests on rats and guinea pigs but not on humans,” said Medical and Health Officer (Hyderabad district) Jaya Kumari. “The permission of Axis Laboratory has been suspended pending investigation.”

Were these side-effects?

The women were taken to the laboratory at least four times a month for blood tests. Each test was done after they were administered a dose of the drug, details of which are still unavailable.

Besides severe pain in the joints, back and body which prevented them from attending work, six of the women complained of slothfulness and lethargy besides general loss of interest in surroundings. The women hail from Piduguralla town, about 300 km from Hyderabad, in Guntur district.

The arrested agents, Kommu Karunamma and SK Jameela, allegedly lured them with Rs 10,000 each.

“The illiterate women are from poor backgrounds,” said Guntur district medical and health officer M Gopi Naik.

Ravindra said the government would take up the issue with the Centre to introduce a legislation to curb clinical trials on humans.

Chief Minister N Kiran Kumar Reddy has directed the medical and health authorities to take stern action against Axis Laboratory.

Though District Revenue Divisional Officer Srinivasulu lodged a police complaint, no case had been registered until late evening on Friday. The police were undecided over whether to lodge the complaint in Piduguralla, the town where the women live, or in Hyderabad, where the laboratory is situated and where the women were taken for tests.

Taking suo motu cognisance of the matter, the State Human Rights Commission has sought a report from state medical and health secretary.

Lab: test on only one woman

A spokesperson of Axis Clinicals said, “We conducted tests on one woman, P Dhana Lakshmi from Piduguralla. We have permission from the Central Drug Control Authority to conduct clinical trials.”

http://www.bangaloremirror.com/article/ ... women.html


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PostPosted: Sun Jun 19, 2011 4:21 pm 
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New drugs boost skin-cancer survival, studies find

CHICAGO — Two new drugs have been found to prolong the lives of people with advanced melanoma, representing what researchers say is notable progress against the deadly skin cancer after decades of futility.

The drugs represent success in two new approaches to combating cancer: one by attacking a specific genetic mutation that accelerates tumor growth; the other by unleashing the body's immune system to fight the disease

"This is an unprecedented time of celebration for our patients," Dr. Lynn Schuchter, a melanoma specialist at the University of Pennsylvania, said Sunday at the annual meeting of the American Society of Clinical Oncology, where the results were presented, in addition to being published online by The New England Journal of Medicine.

The drugs do not cure melanoma, except perhaps in rare cases. But experts said they might add two to several months to the expected life spans of people with advanced melanoma. People with metastatic melanoma — meaning it has spread to distant organs — now typically live six to 10 months.

In one trial, 84 percent of patients taking the experimental drug vemurafenib were alive after six months, compared with 64 percent of those receiving an older chemotherapy drug, dacarbazine. Using another statistical measure, the risk of dying was reduced 63 percent.

The effect was so dramatic that the trial was stopped early for ethical reasons, so patients in the control group could be offered vemurafenib instead. As a result, researchers do not know the median survival.

"You don't need to wait for 50 percent of 675 patients to die to conclude that one drug is much better than the other," said Dr. Antoni Ribas of the University of California, Los Angeles, an investigator in the trial. Ribas, like Agarwala, has been a consultant to the developers of the melanoma drugs.

The other new drug, ipilimumab, when combined with dacarbazine, extended median survival to 11.2 months compared with 9.1 months for those who received dacarbazine alone. After three years, 20.8 percent of those who received ipilimumab were alive compared with 12.2 percent of those in the control group.

Manufacturers of the two drugs are planning trials to use both agents together to see if the combination can improve outcomes further.

To be sure, more than half of patients with metastatic melanoma would not be helped all that much by either drug. Experts say more needs to be done, especially since melanoma affects more young adults than many other types of cancer.

Still, doctors and patient groups welcomed the progress because until now treatment of melanoma that had spread beyond the skin to distant organs "was terrible even by routine cancer standards," said Dr. Vernon Sondak, chairman of cutaneous oncology at the Moffitt Cancer Center in Tampa, Fla.

Also, the number of melanoma cases has been rising steadily, unlike for many other types of cancer. Doctors cite unprotected sun exposure years ago, the proliferation of tanning salons and perhaps more attention to detecting the disease.

About 68,000 new cases of melanoma are diagnosed in the United States each year, and about 8,700 people die, according to the American Cancer Society. The fastest increases in incidence have been among people older than 65 and among women 15 to 39 years old.

Vemurafenib is the latest so-called targeted therapy, which inhibits the effects of genetic mutations that spur tumor growth and spread. In particular, the drug counters the effect of a mutation in a gene called B-RAF that was discovered in 2002 to be common in melanomas. (The drug's name comes from V600EB mutation).

The drug, taken orally twice a day, would be used only for the roughly half of melanoma patients who have this mutation. The drug significantly shrinks tumors in about half of these patients — or about one-quarter of all melanoma patients.

Vemurafenib was developed by Roche and Plexxikon, a Berkeley, Calif., biotechnology company recently acquired by Daiichi Sankyo of Japan. The drug is expected to be approved by the Food and Drug Administration (FDA) within months.

In the trial, sponsored by Roche, 38 percent of participants had to stop taking the drug or lower the dose because of side effects, including rash and joint pain. Many patients develop minor skin cancers that can be removed by dermatologists.

Questions have been raised about whether the trial should have been conducted, since many experts believed, based on results from earlier, uncontrolled trials, that vemurafenib would be much better than the older drug.

Peter Hirth, chief executive of Plexxikon, said the FDA insisted on a controlled trial in order to approve the drug. Dr. Richard Pazdur, head of cancer drugs at the FDA, said through a spokeswoman that he was not allowed to discuss specifics but said the agency did not always require a controlled trial for cancer drugs.

Ipilimumab, the other new drug, releases a brake on the body's immune system, allowing it to attack the tumor more effectively. Developed by Bristol-Myers Squibb, it was approved in March and is sold under the name Yervoy.

That trial, paid for by Bristol-Myers, involved 502 patients with late-stage melanoma. The drug also can have serious side effects, notably liver damage.

Cost is the chief drawback of both drugs. Yervoy costs $120,000 for a course of treatment. A price for vemurafenib hasn't been announced, but it is expected to be at least tens of thousands of dollars per year.

http://seattletimes.nwsource.com/html/h ... oma06.html


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PostPosted: Mon Jun 20, 2011 10:08 am 
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Ballarat women have chance to join cancer trial

POSTMENOPAUSAL women who have had breast cancer are needed for a trial.

Run by Ballarat Oncology and Haematology Services, the trial is giving local women the chance to be part of an international trial by the Australian New Zealand Breast Cancer Trials Group.

Known as LATER, the trial is looking at whether breast cancer can be prevented from recurring.

Women who had breast cancer more than five years ago and were given tablet medication such as tamoxifen or femara for at least four years may benefit.

The trial is looking at whether the breast cancer treatment drug letrozole can prevent or delay breast cancer returning in women who have had hormone sensitive breast cancer in the past.

Women joining the study take a tablet a day for five years if they are in the treatment group. They also have their bone health monitored and regular mammograms, plus clinical check-ups.

More than 180 women have already joined the study, but a further 1500 are needed.

The study will be closing to volunteers early next year. For more information, call 1800 039 634 or visit www.anzbctg.org

http://www.thecourier.com.au/news/local ... 00008.aspx


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