AbledCauses-The Legacy Of Save Lockys Dad-Right To Try Laws Access Unapproved Drugs

POSTED ON July 24th  - POSTED IN AbledCauses
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AbledCauses Post Banner shows Amy Auden, the widow of Nick Auden leaving a memorial service for her husband at St. Andrews Church in Brighton, Australia. She has long brown hair and his wearing a shamrock green coat and is walking between two unidentified women. She is looking down, her face full of grief and her eyes full of tears. The headline reads: AbledCauses: The Legacy of 'Save Locky's Dad': 'Right To Try' Laws To Access Unapproved Drugs.

It was one of the bravest and heartbreaking fights – and at the same time – one of the most unfair. While Nick Auden didn’t live long enough to see it, the legacy of the ‘Save Locky’s Dad‘ campaign is galvanizing state governments across the United States into passing ‘Right To Try‘ laws to allow terminally-ill patients, in consultation with their doctors, to gain access to experimental drugs not yet approved by the FDA.

But it’s not an achievement without controversy. Read more about the laws and the issues they are raising by clicking on the additional tabs in this section. 

In mid-May, 2014 in the Auden family’s adopted state of Colorado, Governor John Hickenlooper signed into law the first ‘Right To Try’ law in the United States to allow terminally-ill patients to gain access to experimental drugs without federal approval.

The ‘Right To Try’ For The Terminally Ill

by Michael Ollove | Stateline

Photo by Justin Ferland Photography shows 15 year old Austin Leclaire sitting in an electric wheelchair with his left arm around the shoulder of his 12 year-old brother Max in the backyard of their home in Pembroke, Massachussetts. Both show the physical effects of Duchenne muscular dystrophy but they are less pronounced in Max who is receiving experimental drugs for the disease. Both boys are smiling at the camera and you can see fallen autumn leaves and a woodpile in the background.

Fifteen-year old Austin Leclaire and his brother Max, 12, of Pembroke, Massachusetts, share the deadly degenerative disease Duchenne muscular dystrophy. But over the course of the past 144 weeks, the boys’ physical conditions have progressed in opposite directions.

Max has regained functions – he has abandoned his wheelchair and can now run, tote his own backpack to school and even ride a bike. Austin’s capabilities are diminishing. He cannot walk at all, and he’s lost the ability to brush his teeth or hold a water bottle. He expects that soon he won’t be able to play drums anymore, one of his few remaining physical pleasures.

The difference in their  trajectories is that Max has been in a clinical trial for nearly three years, during which he has been given weekly infusions of the experimental drug eteplirsen, manufactured by Sarepta Therapeutics Inc. Austin was deemed unqualified to get the drug because of his more advanced condition.

Withholding experimental drugs from the most gravely ill has fueled several states to pass so-called “right-to-try” legislation that would make these drugs available without Food and Drug Administration approval to terminally ill patients with no other options. 

Some critics of the years-long FDA drug approval process, with its requirement for multiple clinical trials, contend that it is much longer than it should be, thereby keeping some promising drugs from those who might benefit, particularly those, like Austin, with time running out. The Tufts Center for the Study of Drug Development says it normally takes 5½ to 10½ years for a drug to receive FDA approval.

Because of that, Colorado, Missouri and Louisiana all passed right-to-try legislation this year that would enable those with terminal illnesses and no other treatment options to secure investigational drugs before final FDA approval if the drug manufacturer is willing to provide them. Arizona voters will decide a similar measure in a referendum in November.

The legislation passed overwhelmingly and with bipartisan support, often after lawmakers heard anguished testimony from terminally ill patients or their families.

The laws would cut the FDA out of the process, at least in terms of a single, terminally ill patient. The decision would be left entirely in the hands of the patient, the doctor and the drug company.

Whether these laws would withstand a court challenge is an open question. Typically, state laws cannot supersede federal statutes. Even if the laws don’t withstand a challenge, advocates say, they may serve a valuable service in spotlighting the issue.

“(A lawsuit) wouldn’t be all bad news because it would further elevate this issue in the public arena and put pressure on Congress and the FDA to make this change and literally save thousands of lives every year,” said Frank Burroughs, head of the Abigail Alliance for Better Access to Developmental Drugs, which he founded 13 years ago after his 21-year-old daughter died of cancer.

So far, only Colorado’s law has taken effect, a little over a month ago. The Goldwater Institute, a conservative nonprofit that defends states’ rights,  created the model legislation for the new laws.  While it has received word of interest, no patients have yet formally tried to receive an experimental drug under the new law, the institute said.

FDA’s Slow Process

Under FDA rules for drug testing, Phase One, the first studies to use human subjects, is quite limited in the number of patient participants (typically 20 to 80, according to theFDA website on the drug approval process). This first step is intended to determine the drug’s most frequent side effects and how the drug is metabolized and excreted.

If Phase One doesn’t reveal unacceptable toxicity, the drug can be approved for Phase Two trials, where the emphasis is on testing the effectiveness of the drug. This stage can involve a few dozen to 300 patients. If the drug passes muster, it goes onto Phase Three, which gathers additional evidence on safety and effectiveness and involves from several hundred to 3,000 subjects.

In the Leclaire brothers’ case, those selected for the trial had to still be ambulatory most of the time, but with the expectation that their walking days would end within a year, said Jenn McNary, the boys’ mother. Max fell down occasionally, but he still didn’t need the wheelchair most of the time. Austin no longer qualified.

So even as Austin has watched Max get stronger from the drug treatments, he wonders what motor skill he will lose next. And while he hopes s one day to earn degrees in mechanical engineering and zoology, he is aware that those with his condition rarely survive their twenties.

“I’m glad that Max has (the treatments), and he’s proving that it does work, and I should have it, too,” Austin said by phone from home. “But it’s also unfair…. I’m just really upset that the FDA won’t approve the drug, and it’s their fault that someone might die.”

The FDA has taken no official position on the new laws. “While the agency is supportive of patients’ access to experimental new treatments, the FDA believes that the drug approval process represents the best way to assure the development of safe and effective new medicines for patients,” an FDA statement said.

Although there are already provisions in place that allow for expedited approval of drugs and to make certain experimental drugs available to individuals prior to final approval, the Goldwater Institute insists that even those procedures take too long for a person whose time is running out. “A lot of patients don’t have five or six months” that those procedures take, said Victor Riches, a Goldwater spokesman.

The FDA  said it receives about 550 applications a year from drug companies to supply drugs to individuals before final approval and agrees to nearly all of them.

Rare Diseases

But that doesn’t account for patients who have been turned down by manufacturers, such as Holly Singh, a Texas second grade teacher whose 14-month-old daughter Harper has spinal muscular dystrophy, which leaves her incapable of picking her head up, crawling or rolling over. Without help, her life expectancy is quite limited.

Singh applied to Isis Pharmaceuticals, developer of the promising drug, ISIS-SMN-rx, which is soon to enter Phase Three clinical testing, for early access to the drug. In turning down her request, Isis chairman Stan Crooke raised the possibility that granting it could have prolonged the overall testing program and delayed the drug’s approval for other patients. He also said that all the safety concerns had not been fully addressed.

Singh’s correspondence with Crooke demonstrates her desperation.  She wrote, “What kind of mother would I be if I just told my child, ‘I’m sorry that there’s a drug, but unfortunately you can’t have it.  You just need to suffer a little while longer.’”

While sympathetic to the situation of individual patients, the pharmaceutical industry has been far from enthusiastic about the right-to-try laws.

“We have serious concerns with any approach to make investigational medicines available that seeks to bypass the oversight of the Food and Drug Administration and clinical trial process, which is not in the best interest of patients and public health,” said Sascha Haverfield, vice president of scientific and regulatory affairs for thePharmaceutical Research and Manufacturers of America. He suggested that medical providers, the pharmaceutical industry and FDA should seek ways to improve access to clinical trials.

Critics of the new laws contend that Phase One trials are too limited to assure that a drug can be safely used. “Safety (in Phase One) is tested in only the crudest way you can imagine, making sure it doesn’t kill people,” said David Gorski, an associate professor of surgery at Wayne State University and the editor of the Science-Based Medicine blog, which has been critical of right-to-try laws. Even for terminally ill patients, Gorski argues, the risks are too great based solely on Phase One trials.

“They say it couldn’t get any worse.” Gorski said. “Well, yes, it can get worse. If there’s anything worse than dying of a terminal disease, it’s added suffering and potentially cutting the time you have left.”

According to a January article in the journal Nature Biotechnology, only 16 percent of investigational drugs that complete Phase One clinical trials ultimately gain FDA approval.

Still, patients and families say they feel that they should be free to take the chance given that the alternative is death. “I should be able to take the risk of whether or not it would help,” said Austin Leclaire. “It’s my life.”

Proposed laws on experimental drugs stir debate

BY STEPHEN FEE PBS Newshour Weekend

This May, Colorado’s governor signed the nation’s first ”right to try” bill, which allows terminally ill patients to try unapproved — and potentially dangerous — drugs outside of clinical trials and without approval from federal regulators.

Missouri and Louisiana have passed similar statutes, and Arizona voters will vote on their own version this fall.

For the NewsHour Weekend broadcast, we profiled the Missouri State Representative Jim Neely who introduced that state’s bill and his daughter, who is fighting a deadly form of cancer.

Neely is backed by Phoenix-based Goldwater Institute and by patients and families who have lost relatives to diseases, but the proposed measure is not without controversy. While FDA remains neutral in the legislation debate, there are opponents to these type of laws.

To get more context about the debate surrounding “right to try,” I spoke with Julie Rovner of Kaiser Health News.

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March 13, 2014 : A Bittersweet Victory

UPDATE FROM JULIA MEDEW, Health Editor – Sydney Morning Herald

 

AbledCauses- photograph of the Auden family  sitting on the step of a wooden shed painted with pastel light blue and  yellow vertical stripes. From left to right they are father Nick Auden, 7 year-old son Locky, 5 year-old daughter Hayley, while mother Amy holds their year old son Evan. The photo is by Catherine Sutherland.

 

In cruel timing, Merck announced this week that it was launching an “expanded access program” for its PD-1 drug Lambrolizumab (or MK-3475) in the US for people “who have serious or immediately life-threatening illnesses for which no comparable or satisfactory alternate therapies are available.”

A spokeswoman for the company said it planned to make the scheme available to Australian patients “at the earliest possible time” but did not say when that could be. At the moment, only 175 patients with melanoma are receiving the drug in clinical trials.

Mr Auden’s bereaved wife Amy Auden welcomed the program but said the timing was “absolutely devastating”.

“Words cannot express the emotion I feel… The people at Merck said that they did not want to ‘play God’ by giving the drug to Nick (they were concerned about not having enough of the drug for everyone with stage 4 melanoma), however by denying Nick the drug, they in effect did just that,” she wrote in an email.

“Every minute of every day I am reminded that Nick is not here and I am widowed at 38 with 3 young kids. Right now, however, I am trying to focus on the fact that were it not for the campaign, a compassionate use program for the new melanoma breakthrough drug would not be a reality for others.”


Read more at the Sydney Morning Herald
 

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November 22, 2013 : THE SADDEST UPDATE

 

The man known around the world as ‘Locky’s Dad’ has lost his battle with cancer. Nick Auden died on November 22 at the age of 40.

 

Photo of Nick Auden. He is sitting in front of a window in a tall office building dressed in a suit and dress shirt with an open collar. He has sandy blonde hair cut neatly and is smiling at the camera.

 

 

He leaves behind his wife,  Amy and children 7 year-old Laughlin (‘Locky’), 5 year-old Hayley, and 1 year-old Evan.

The story of his battle with Stage IV melanoma went viral after his wife Amy started a petition at change.org to garner support and put pressure on pharmaceutical giants Bristol Meyers Squibb and Merck to give Nick special access to a couple of experimental ‘PD-1’ drugs that were showing great promise that were in clinical trials. Over 525 thousand people signed the petition.

And even though the U.S. Food and Drug Administration (FDA) said Nick could use the drugs if one of the companies gave him access but they refused saying they were only available to people in clinical trials.

Despite the PD-1 drugs lambrolizumab and nivolumab offering groundbreaking results, a series of small brain tumours prevented Mr Auden from initially qualifying for clinical trials of the wonderdrugs. 

 

This past July, Nick was finally accepted for a trial only to suffer a partial blockage in his bowel, which again ruled him out.

 

Following a funeral in the United States, Amy and the children returned to Australia for a memorial service there. She told the Herald Sun News in Melbourne, that, returning home without her soulmate was the toughest thing she had ever done.

“It’s really difficult coming back to Melbourne because I come here without Nick. We met here, and it is just so hard for me to come to terms with. Locky is absolutely devastated. When he asks me the really difficult questions, like who is going to teach me football … I am hoping that with our friends and family together we can show Lachlan what Nick would have suggested and how he would have guided him. Hayley is too young and she is just asking me ‘when is daddy coming back’.”

 

Nick Auden with his son Lachlan in combine harvester in happier times.

 

While Evan will be too young to remember his father, Amy has thousands of messages from people inspired by their campaign that she will treasure to show her children what a great man their father was.

With her children settled in the United States,  Amy said it was too early to make a decision about whether her family would return to Australia in the long-term. But she has promised to continue her husband’s legacy and pressure pharmaceutical companies to improve compassionate access for desperate patients.

All of us at Abled.com are heartbroken by the news and offer our heartfelt condolences to Amy and her children. We will keep this post current on our site as a tribute to Nick’s courage and perseverance and will join the fight to lobby for compassionate access to experimental drug treatments.

The Original Post

AbledCauses story banner shows Nick and Amy Auden of Lone Tree, Colorado and their three young kids with the headline: Save Locky's Dad: Dying Dad Pleads For Unapproved Drug.

 

 Disqualified from a clinical trial, Nick Auden fights for ‘compassionate’ use of PD-1

 

“When you’ve been given a terminal diagnosis, you’re prepared to accept a drug that’s 50 percent effective. Safety concerns don’t really figure in the same way.” Those words, spoken by Nick Auden in an interview with ABCNews.com, sum-up his fight to get access to what’s being called a new ‘wonder drug’.

The 40 year-old father of three was diagnosed with Stage 4  melanoma in September of 2011. On July 2nd of this year he was admitted into a clinic trial for a drug called PD-1 that helps a patient’s own immune system shrink cancer tumors for good. But a blocked bowel the very same day sent him to the ER and out of the trial.

Now, he and his wife Amy are fighting for him to become an individual case study under compassionate-use rules which can give people access to experimental drugs that haven’t passed FDA approval outside of a clinical trial, and they’ve launched a petition campaign at Change.org to lobby pharmaceutical giants Merck and Bristol-Meyers-Squibb to provide the treatment.

The Audens’ 7 year-old son Lachlan, nicknamed “Locky,” is included in a video on the “Save Locky’s Dad” website asking for people to support his dad. The “Save Locky’s Dad” campaign has skyrocketed since launching two weeks ago with the goal of reaching 150,000 signatures. Once it attained that goal, the Audens raised it to 200,000. 

Now with more than 258,000 signatures, the goal is 300,000 and as more media outlets share the story, it’s quite likely they’ll reach and even surpass that goal very soon.

Watch the ‘Save Locky’s Dad’ video below:

 

 

Read more of the interview with ABCNews.com |  SIGN THE PETITION HERE

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AbledConditions-Prostate-Cancer-Vitamin-E-And-Selenium-Supplements-May-Double-Your-Risk-For-It

POSTED ON March 7th  - POSTED IN AbledConditions
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AbledConditions Post Banner shows a digital display of an MRI scan of a prostate with certain areas showing blue, green or red. The headline reads: AbledConditions: Prostate cancer: Vitamin E and Selenium Supplements May Double Your Risk For It.

The Risk Depends On Your Selenium Status Before Taking The Supplements

 

A multi-center study led by the Fred Hutchinson Cancer Research Center in Seattle, Washington, has found that high-dose supplementation with both the trace element selenium and vitamin E increase the risk of high-grade prostate cancer. But importantly, this risk depends upon a man’s selenium status before taking the supplements.

 

 
The findings, published in the Journal of the National Cancer Institute, are based on data from the Selenium and Vitamin E Cancer Prevention Trial, or SELECT, a rigorously executed, randomized and placebo-controlled trial conducted by the Portland, Oregon-based SWOG cancer research co-operative group that involved more than 35,000 men. The study sought to determine whether taking high-dose vitamin E (400IU/day) and/or selenium (200mcg/day) supplements could protect men from prostate cancer.

 

 
The trial, which began in 2001 and was designed to last 12 years, stopped early, in 2008, because it found no protective effect from selenium and there was a suggestion that vitamin E increased risk. While use of the study supplements stopped, men were still followed and after an additional two years the men who took vitamin E had a statistically significant 17 per cent increased risk of prostate cancer.

 

 
When the study started, there was some evidence that selenium supplementation would not benefit men who already had an adequate intake of the nutrient. For that reason, researchers measured the concentration of selenium in participants’ toenails and planned to test whether selenium supplementation would benefit only the subset of men with low selenium status at baseline.

 

Instead, they found that taking selenium supplements increased the risk of high-grade cancer by 91 per cent among men with high selenium status at baseline. When selenium supplements were taken by men who had high selenium status to begin with, the levels of selenium became toxic.

 

 
The study also found that only a subgroup of men was at increased risk of prostate cancer from taking vitamin E. Among men with low selenium status at baseline, vitamin E supplementation increased their total risk of prostate cancer by 63 per cent and increased the risk of high-grade cancer by 111 per cent.

 

This explained one of the original SELECT findings, which was that only men who received vitamin E plus a placebo pill, and not those who received both vitamin E and selenium, had an increased prostate cancer risk. Selenium, whether from dietary sources or supplements, protected men from the harmful effects of vitamin E.

 

 
“Many people think that dietary supplements are helpful or at the least innocuous. This is not true,” said corresponding and first author Dr. Alan Kristal, a faculty member in the Public Health Sciences Division of Fred Hutch. “We know from several other studies that some high-dose dietary supplements — that is, supplements that provide far more than the daily recommended intakes of micronutrients — increase cancer risk. We knew this based on randomised, controlled, double-blinded studies for folate and beta carotene, and now we know it for vitamin E and selenium.”

 

Journal of the National Cancer Institute; U10 CA037429

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Cancer Protector or Cancer Promoter?

Another perspective on Selenium and Vitamin E

By Rob Verkerk PhD – Executive and Scientific  Director, Alliance for Natural Health International

Can Vitamin E and selenium supplements increase prostate cancer risk?

Newspaper headlines this week claim that vitamin E and selenium supplements may increase, rather than decrease as originally thought, the risk of prostate cancer.

SELECT groups

You may remember reading similar headlines about selenium and vitamin E supplements and prostate cancer from 2008.  Both these findings relate to a large trial – the Selenium and Vitamin E Cancer Prevention Trial (SELECT) – started in 2001 and involving over 35,000 men studied in more than 400 centres in the United States, Puerto Rico and Canada. The men were considered to be at moderate risk of prostate cancer based on prostate-specific antigen (PSA) scores and digital rectal exams, and were randomised to four different treatment groups:

  1. Vitamin E alone (400 IU/360 mg per day, equivalent to 3,000% of the European RDA), with selenium placebo
  2. Selenium alone (200 mcg per day as L-selenomethionine, or 360% of the European RDA) alone,  (with vitamin E placebo)
  3. A combination of both supplements
  4. Full placebo.

 

High-dose synthetic vitamin E: No thanks

The treatments were stopped in 2008 after the SELECT safety monitoring committee for SELECT issued a unanimous recommendation opinion that the goal of a 25% reduction in incidence of prostate cancer among any of the treatment groups would be highly unlikely. The initial results from the first 7 years of follow-up showed no evidence of any net reduction, and a small, but statistically non-significant, increase in risk among the vitamin E-only group.

Needless to say, the vitamin E form being taken was the now somewhat infamous synthetic DL alpha-tocopherol, which suppresses the beneficial gamma-tocopherol form of vitamin E, the most common form consumed via the diet.

Further follow-up results published in 2011 showed that, for every 1,000 men, 76 of those taking the vitamin E supplements alone developed prostate cancer, as against 65 on placebo. Those additional 11 cases per 1,000 amounted to a statistically significant 17% increase. That generated headlines around the world, and high-dose synthetic vitamin E – justifiably – got another kicking.

 

Why did SELECT not work to plan?

Publishing in the Journal of American Medical Association (JAMA), the authors considered a host of reasons why the anticipated 25% prostate cancer risk reduction threshold was not realised. They mulled over the possibilities that the vitamin E dose may have been too high, that it was the wrong form of vitamin E, and that the selenium form used in SELECT – selenomethionine – may not be as good as the selenium yeast shown to be beneficial in previous trials. Theoretically, this could be related to the synthetic nature of the methionine part of the selenomethionine supplement used in SELECT: a form that may best be described as ‘biosynthetic’. They referred to other trials, like the Alpha-Tocopherol, Beta Carotene (ATBC) trial and Nutritional Prevention of Cancer (NPC) Trial, in which selenium yeast showed a protective effect, and the Physicians Health Study II, in which lower-dose vitamin E (50 IU as against the 400 IU used in SELECT) was also found to be beneficial.

 

Latest SELECT findings

The latest swathe of negative headlines followed the issue, on 21st February this year, of press releases linked to new findings released ahead of print in the Journal of the National Cancer Institute (JNCI).

Last year, a picture emerged from SELECT of older men with double the risk of prostate cancer in the selenium or vitamin E arms of the study and high selenium status, as measured in their toenails. The latest JNCI findings show that those whose selenium status was high at the start of the study, and who then took selenium supplements, were at significantly increased risk of developing more aggressive forms of prostate cancer.  It also confirms the risk associated with high-dose synthetic vitamin E, but also shows that this risk is confined to subjects with low selenium status.

 

Take-home messages

Taking the results at face value, the key messages from the JNCI data are perhaps simpler than it might seem:

  1. Don’t take synthetic high-dose (over 200 IU/180 mg per day) synthetic vitamin E on any account
  2. Taking natural vitamin E at a moderate dose will likely be protective.

The data also suggest that men shouldn’t take high-dose (200 mcg/day or more) selenium in the form of L-selenomethionine if they already have high selenium status.  Based on other trials, such as the Nutritional Prevention of Cancer (NPC) Trial, selenium yeast was found to be protective against both prostate and skin cancers when taken at 200 mcg/day, but this effect was again limited to those with low selenium status.

 

Double-edged sword

This research shines more light on the double-edged sword of selenium in cancer: on one hand a protector against it, while on the other, a potential cancer promoter. Selenium’s role as an essential nutrient has been very well studied. But, as is the case with some micronutrients, more is not always better – and the form, as well as an individual’s specific needs, are key. Critically, sufficient selenium status is needed to reduce DNA damage, and it plays a key role in supporting vital glutathione antioxidant enzymes. Let’s face it, in the US, thanks to a successful lawsuit against the FDA by our colleagues at ANH-USA, the words selenium and cancer can appear on the same product label under the tight conditions of a qualified health claims regime.

Yet, as is so often the case, it will in time likely become increasingly apparent why these new results have emerged. Possible explanations may include artefacts of the experimental set-up, the effect of unblinding the trial and the wrong groups being given the wrong forms and an inappropriate amount of the micronutrients.

Across a diverse group of average-risk men, as is the case in SELECT, who took the supplements for an average of just 5 years yet were followed-up for 12, it’s not possible for benefits among specific groups to be isolated. Then, we must bear in mind that negative news, especially about synthetic vitamin E, has been rampant in the media for most of the duration of the study. How do you think this would have affected you, had you been a participant in the trial? 

As increasing evidence of the emotional and psychological triggers for cancer emerge, could it be that one day we’ll recognise this as a factor mediating additional risk in trials? And let’s not forget the potential direct and indirect impact of the biopsies used to confirm the presence of cancer in SELECT.

 

It’s the dosage – and form – stupid!

Melchor and Timmermans, two lawyers interpreting various rulings by the European Court of Justice as to which botanical products should be viewed as food supplements or medicines, famously titled their 2009 paper “It’s the dosage, stupid”.

This notion could equally be applied to vitamin E and selenium. Except it’s also about the form of the nutrient – and the recipient population. This is something central to the risk/benefit assessment that the Dutch research scientists at TNO are grappling with at present, as they develop a risk/benefit approach applicable to vitamins and minerals following our commissioning of them late last year.

It’s not hard to fathom why we face such a plethora of papers showing conflicting results. Artefacts of the study, the effect of unblinding, increased concomitant treatments among those subject to screening or biopsy and genetic risk or predisposition, including specific genetic polymorphisms and an individual’s epigenetic profile, all provide a highly variable backdrop to these studies. But there’s much more too. The duration of intake or supplementation, the length of follow-up, what pre-cancerous processes may already have been initiated prior to the start of supplementation trials and interactions with other nutrients or drugs can also play key roles. For a given individual, taking too much or too little of a less-than-ideal form of the nutrient is crucial.

 

Doing nothing ain’t an option!

If you study the background science and the few large trials that placed question marks over high-dose supplementation of synthetic vitamin E, beta-carotene, folic acid and now selenium, one consistent pattern emerges: Elevated levels of these vitamins taken in optimal forms – from the diet – are consistently protective against cancer. There is also clear evidence that some supplementation trials have worked very well indeed. These facts alone mean that, for the vast majority of men, doing nothing isn’t the best option.

We must bear in mind that micronutrients cannot be considered in the same way as drugs. Not everyone needs the same amount, nor are all forms of micronutrient given in supplemental form the same, nor are they necessarily equivalent in their effects to those we get from our diets.

That’s why people at particular risk of cancer and other chronic diseases – and that means most aged 50 or over, as well as those with a high familial risk – should be assessed for their nutritional status by a practitioner skilled in such matters. It’s a sad fact that the average general practitioner has little or no background in this area, and can do little to check your status or recommend an appropriate dietary, nutritional and lifestyle protocol relevant to you.

By contrast, functional medicine practitioners are the primary group trained specifically in this field.

If you’re concerned, use your contact network, the Internet or other means to find an experienced and qualified functional medicine practitioner who can provide the support you deserve.

 

Non-standard therapies could save your life – and its quality

For those wishing to avoid biopsies, chemotherapy, radiotherapy or surgery, and wanting to benefit from the views of over 50 specialist doctors and health practitioners specialising in prostate cancer, we can’t recommend highly enough Peter Starr’s documentary, Surviving Prostate Cancer Without Surgery, Drugs or Radiation. As Peter Starr, ex-motorcycle stuntman, film director and ANH supporter himself asserts, the film should be essential viewing for all men over 40.

 

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AbledHealth-Longevity-Eating-Nuts-May-Prolong-life

POSTED ON November 24th  - POSTED IN AbledHealth
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Study also sees 29% reduction in heart disease

 

It’s the largest study of its kind that followed close to 120,000 people over 30 years which not only saw reductions in the death rates of participants, but also reduced risks of deaths from heart disease and cancer.

 

The study is published in the New England Journal of Medicine and found that the biggest benefit was seen from eating a daily portion of nuts. Eating nuts has been associated with a decreased risk of developing a number of major diseases, including heart disease and diabetes, but there had never been a study examining the association between nut consumption and mortality.

 

What likely has an impact on the study is that the participants consisted of  76,464 women in the Nurses’ Health Study (1980–2010) and 42,498 men in the Health Professionals Follow-up Study (1986–2010). Participants with a history of cancer, heart disease, or stroke were excluded.

 

The research team said nut eaters were also likely to have healthy lifestyles, including being less likely to smoke or be overweight and more likely to exercise, but they say the nuts themselves were also contributing to the longer lifespans.

 

Among the results:

 

Eat nuts 1x a week = 11% reduction in death rate

Eat nuts 4x a week = 13% reduction in death rate

Eat nuts 7x a week = 20% reduction in death rate

 

Lead researcher Dr Charles Fuchs, from the Dana-Farber Cancer Institute and Brigham and Women’s Hospital, said: “The most obvious benefit was a reduction of 29% in deaths from heart disease, but we also saw a significant reduction – 11% – in the risk of dying from cancer.”

 

Funding for the study came from the US National Institutes of Health and the International Tree Nut Council Nutrition Research & Education Foundation (nuthealth.org).

 

 

Nut consumption and risk of pancreatic cancer in women

 

Increasing nut intake has also been associated with reduced risk of diabetes mellitus, which is a risk factor for pancreatic cancer. After adjusting for age, height, smoking, physical activity, and total energy intake from the same study group, NutHealth.org found that women who consumed a 28-g (1 oz) serving size of nuts up to 2 times per week experienced a significantly lower risk of pancreatic cancer (RR, 0.65; 95% CI, 0.47–0.92; for trend=0.007) when compared with those who largely abstained from nuts. 

 

 

Walnuts Are The Healthiest Nut

 

Photo shows whole and half-shelled walnuts on a white counter top.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Earlier this year, researchers at the University of Scranton, Pennsylvania told the American Chemical Society that walnuts contain the highest level of antioxidants compared to other nuts and should be eaten more as part of a healthy diet.

 

Dr. Joe Vinson analyzed the antioxidant levels of nine different types of nuts and found that the antioxidants found in walnuts were 2 to 15 times as powerful as vitamin E and 2 times more powerful than any of the other nuts in the sample.

 

He mentions the walnuts should be eaten raw or unroasted to get the full benefit as the heat from roasting nuts reduces the quality of the antioxidants.

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AbledPeople: Angelina Jolie

POSTED ON May 20th  - POSTED IN AbledPeople
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“The ‘Angelina Effect’ has been long-lasting and global and appears to have increased referrals to centres appropriately.”

That’s the word from a team led by Professor Gareth Evans of the University of Manchester in Great Britain. Referrals to breast cancer clinics more than doubled in the UK after Angelina Jolie announced in May, 2013 that she had undergone a double mastectomy as a preventative measure after being told she had an 87 percent chance of developing cancer because she carried the BRCA1 gene mutation.

The researchers looked at referrals to more than 20 genetic centers and clinics in the UK  in the two months that followed Jolie’s revelation and found the number of GP referrals for  genetic counseling and DNA tests for the BRCA1 gene mutation increased more than 2.5 times over the same period a year earlier.

The study, published in the journal Breast Cancer Research, found the effect lasted by about the same proportion from August to October, and mirrored trends around the world.

Here’s a summary of results from various countries:

UNITED KINGDOM: Study finds the ‘Angelina Effect’ prompted a 2.5x surge in women undergoing genetic testing for breast cancer.

UNITED STATES: Testing for breast cancer genes has doubled since Angelina Jolie’s essay on her double mastectomy. On June 13, 2013, the U.S. Supreme Court also removed the patent on  breast cancer gene testing, making it more widely available and affordable. Jolie’s essay in the New York Times had been published concurrently with the Supreme Court deliberations on the validity of the BRCA gene patent rights held by Myriad Genetics, and she had acknowledged the largely prohibitive cost of the gene mutation testing and advocated wider accessibility.

CANADA: Study done by Sunnybrook Hospital’s Odette Cancer Centre in Toronto shows the number of women at high risk for hereditary cancer considering genetic testing has doubled following Angelina Jolie’s revelation of her preventative choices.

 AUSTRALIA: Referrals to cancer genetic clinics tripled. The Cancer Council of Victoria reported a 1,033 percent increase in calls to its helpline.

NEW ZEALAND: Calls to breast cancer helpline tripled following Angelina Jolie’s decision to undergo a double mastectomy.

Praise and Criticism Followed Preventative Procedure

 

Angelina Jolie, Oscar®-winning actress and director, and Special Envoy of UN High Commissioner for Refugees António Guterres, dropped a bombshell in a New York Times Op-Ed piece that she had undergone a double mastectomy as a preventative measure against against breast cancer.

As the news spread virally online and by word-of-mouth, the focus was more on the mastectomy rather than the careful and sober reasoning behind the decision, prompting some ill-informed criticism across the blogosphere.

Those who took the time to read a little further into Jolie’s op-ed learned that, “I had an 87 percent risk of breast cancer and a 50 percent risk of ovarian cancer, although the risk is different in the case of each woman. Only a fraction of breast cancers result from an inherited gene mutation. Those with a defect in BRCA1 have a 65 percent risk of getting it, on average”.

Jolie’s risk was inherited from her mother, actress Marcheline Bertrand. “My mother fought cancer for almost a decade and died at 56,” Jolie writes. “She held out long enough to meet the first of her grandchildren and to hold them in her arms. But my other children will never have the chance to know her and experience how loving and gracious she was.”

 

Photos of Marcheline Bertrand and Angelina Jolie at different ages

 

Jolie’s mother died in January 2007. She had small roles in the movies “Lookin’ to Get Out” in 1982 and “The Man Who Loved Women” in 1983. She raised Jolie and her brother after divorcing their father, Oscar®-winning actor Jon Voight, when Jolie was a toddler.

Cancer has taken a horrible toll on Jolie’s relatives on her mother’s side of the family. Her aunt Debbie was also fighting a losing battle with BRCA1 at the time of Angelina’s announcement and died soon after. More on her condition was revealed in the following report on the TV program Inside Edition:

 

Link to Inside Edition story about Angelina Jolie's Aunt Debbie and her battle with breast cancer

 

Jolie has appeared in dozens of films including 2010’s “The Tourist” and “Salt,” the “Tomb Raider” films, and 1999’s “Girl, Interrupted,” for which she won an Academy Award. But she has gained more recognition in recent years for her relationship with Brad Pitt and the family of six children they are raising together, as well as for her charitable work with refugees around the world as a United Nations Special Envoy for the UN High Commissioner For Refugees.

It was that work that led to her directorial feature debut with “In the Land of Blood and Honey” (2011), a love story between a Serb soldier and a Bosniak prisoner of war, set during the 1992–95 Bosnian War. Jolie, who had twice visited Bosnia-Herzegovina in her capacity as a UNHCR Goodwill Ambassador, explained that she made the film to rekindle attention for the survivors of a war that took place in recent history.

After Jolie went public with her Op-Ed, Pitt issued a statement to London’s Evening Standard. “Having witnessed this decision firsthand, I find Angie’s choice, as well as many others like her, absolutely heroic,” Pitt said in the statement. “I thank our medical team for their care and focus.” “All I want is for her to have a long and healthy life, with myself and our children,” Pitt continued. “This is a happy day for our family.”

UK Foreign Secretary William Hague also paid tribute to Jolie, who kept working as a UN Special Envoy throughout the past three months, and made a high-profile trip to the Congo alongside Hague, later appearing with him, and a delegation from the United States, at the G8 Summit in London in April to call for an end to sexual violence in conflict zones.

 

Angelina Jolie at the G8 Summit in London, calls for an end to sexual violence in conflict zones.

   

Hague (pictured left in the above photo) said, “This is a brave choice by a remarkable woman. The courage it must have taken not only to go through this treatment but then to speak about it to help other women is truly inspiring. Throughout it all her humanitarian work has not missed a beat. This is a courageous decision by one of the bravest people I know. I wish her and her family the very best.”

Photo of Angelina Jolie at the G8 summit in the UK in early May, 2013

 

    

“For any woman reading this, I hope it helps you to know you have options.

I want to encourage every woman, especially if you have a family history of breast or ovarian cancer, to seek out the information and medical experts who can help you through this aspect of your life, and to make your own informed choices.

Angelina Jolie

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Angelina Jolie – An Inspiration For Women Everywhere 

This profile of Angelina Jolie is one of many stories that we hope will provide you with inspirational and insightful information to help you ask informed questions of your health care professionals and to help you make informed choices if you face similar circumstances in your own life.

By showcasing her work as a Special Envoy of the United Nations High Commissioner for Refugees, and her pioneering work with former U.K. Foreign Secretary William Hague to end sexual violence in conflict zones, we hope to further raise awareness about the plight of millions of people around the world, and support for proposed solutions.

We’re building global networks to help everyone live a more Abled® life with an emphasis on Content, Products, Services and Technology that are fully accessible and inclusive to persons with special needs, including applications and devices that contribute to more independence and the dignity of self-sustainability.

It’s a work-in-progress and we hope you don’t mind if some of our link banners will lead to an ‘Under Construction’ page, but we hope you’ll visit often to watch our evolution as more links go live, and we thank you for your kind interest and support.

 

Laura Meddens

Co-Founder, Abled.com

Click here to read the original Op-Ed in the New York Times
Link box shows a colored strand of DNA with the caption 'What is BRCA1'. CLick to link to more information at Wikipedia.com
Click here to link to Angelina's treatment journal at the Pink Lotus Breast Center
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