Category: Bioethics


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Hepatitis C treatment cures over 90 percent of patients who also have cirrhosis

Date:
April 12, 2014
Source:
University of Texas Health Science Center at San Antonio
Summary:
Twelve weeks of an investigational oral therapy cured hepatitis C infection in more than 90 percent of patients with liver cirrhosis and was well tolerated by these patients, according to a new study.

Twelve weeks of an investigational oral therapy cured hepatitis C infection in more than 90 percent of patients with liver cirrhosis and was well tolerated by these patients, according to an international study that included researchers from UT Medicine San Antonio and the Texas Liver Institute. Historically, hepatitis C cure rates in patients with cirrhosis (liver scarring) have been lower than 50 percent and the treatment was not safe for many of these patients.

Hepatitis C virus is the No. 1 driver of cirrhosis, liver transplants and liver cancer in the United States, noted Fred Poordad, M.D., lead author on the study, which was released Saturday by The New England Journal of Medicine in conjunction with Dr. Poordad’s presentation of the data at the International Liver Congress in London. UT Medicine is the clinical practice of the School of Medicine at The University of Texas Health Science Center at San Antonio, where Dr. Poordad is a professor of medicine. He is vice president of the Texas Liver Institute in San Antonio.

Interferon previously was the only agent to show effectiveness against hepatitis C, but patients often relapsed and the therapy caused multiple side effects. The new regimen is interferon-free and consists of several agents — ABT-450/ritonavir, ombitasvir, dasabuvir and ribavirin. Twelve weeks after the last dose, no hepatitis C virus was detected in the bloodstream of 91.8 percent of patients who took the pills for 12 weeks. Among patients treated for 24 weeks, 95.9 percent were virus-free 12 weeks after the end of therapy.

 

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 Combination Drug Therapy Amazingly Effective In Tackling Hepatitis C

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ScienceDaily: Your source for the latest research news

 

New combination drug therapy proves very effective in hepatitis C treatments

Date:
April 12, 2014
Source:
Beth Israel Deaconess Medical Center
Summary:
Treatment options for the 170 million people worldwide with chronic Hepatitis C Virus (HCV) are evolving rapidly, although the available regimens often come with significant side effects. Two multi-center clinical trials show promise for a new option that could help lead to both an increase in patients cured with a much more simple and tolerable all oral therapy.

Treatment options for the 170 million people worldwide with chronic Hepatitis C Virus (HCV) are evolving rapidly, although the available regimens often come with significant side effects. Two multi-center clinical trials led by Beth Israel Deaconess Medical Center show promise for a new option that could help lead to both an increase in patients cured with a much more simple and tolerable all oral therapy.

A new 12-week single tablet regimen of ledipasvir and sofosbuvir have proven to be highly effective in treating a broad range of patients with HCV genotype 1, a form of the virus found in up to 75 percent of infections, according to results unveiled today at the European Association for the Study of the Liver and published simultaneously online by the New England Journal of Medicine.

Between 94 percent and 99 percent of patients were cured of hepatitis C and results were similar in patients who have never been treated and for those who had previously been treated with a combination of peginterferon and ribavirin, the current course that carries sometimes significant side effects.

“Eliminating interferon and ribavirin from treatment regimens is expected to reduce the incidence and severity of adverse events, to simplify the treatment of patients with HCV infection and to provide an option for patients who are ineligible for the current interferon-based treatments,” said Nezam Afdhal, MD, the senior author of the studies, Director of the Liver Center at Beth Israel Deaconess Medical Center and a Professor of Medicine at Harvard Medical School.

Hepatitis C is an infectious disease primarily affecting the liver and which can lead to scarring and cirrhosis and is transmitted primarily through blood transfusions (prior to 1991), intravenous drug use, poorly sterilized medical equipment and sexual transmission.. After exposure 80 percent of patients develop a chronic hepatitis which can lead to cirrhosis, liver failure and liver cancer and hepatitis C is the most common cause for liver transplantation in the US.

Prior treatments have been with interferon which is an injectable cytokine released in response to viral infections. Interferon is combined with other antiviral agents and needs to be used for up to 48 weeks to cure hepatitis C. but is associated with number of side effects, including influenza-like symptoms depression and anemia. Many patients are ineligible for these interferon-based therapies.

“The real advances seen in the Ion trials is that the sofosbuvir-ledipasvir combination tablet enables us to treat almost all genotype 1 patients with a short duration of 8-12 weeks of treatment expanding the treatment pool and increasing the overall cure rate,” said Afdhal.

Recent recommendations by the CDC and endorsed by the USPHS Task force have recommended screening of baby boomers (persons born between 1945 and 1965) for hepatitis C since up to3 percent may have silent infection without symptoms.
“Screening for HCV needs to be associated with a safe and effective treatment for these “baby boomers” with newly identified HCV and the ION trials clearly give an exciting new option for these patients” stated Afdhal.

 

 

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Consumer alert: GMO labeling to be outlawed by ‘Safe and Accurate Food Labeling Act’ introduced today in Congress

 

GMO

Thursday, April 10, 2014
by Mike Adams, the Health Ranger
Editor of NaturalNews.com (See all articles…)

 

(NaturalNews) A proposed new federal law just introduced by Rep. G.K. Butterfield (a Democrat) and Rep. Mike Pompeo (a Republican) would outlaw state-enacted GMO labeling laws. The new law, ridiculously called the Safe and Accurate Food Labeling Act, is actually an last-ditch, desperate effort by the biotech industry and the GMA to forever bury the truth about GMOs so that consumers don’t know they’re eating poison.

According to mainstream media reports (1), the bill would require the FDA to mandate GMO labeling only if those foods “are found to be unsafe or materially different from foods produced without biotech ingredients.”

Because the FDA and USDA have already decided, against all scientific evidence, that GMOs are “safe” and “not materially different” from other foods, this requirement is nothing but sheer sleight of hand and a pandering to idiocy. In truth, this new bill, if passed into law, would allow food companies to permanently and insidiously hide GMOs in all their products forever, nullifying the numerous state-based GMO labeling laws which are on the verge of passing.

The Environmental Working Group calls this proposed new law the “DARK Act” (Denying Americans the Right to Know), saying:

After two states have passed GE labeling bills and more than 30 others are poised to consider similar labeling bills and ballot initiatives, the food and biotech industry have goat-roped some members of Congress into introducing legislation to block state GE labeling laws.

Push for GMOs run by criminally-minded organizations

GMOs have already been restricted or banned in over 60 countries (2), and Americans are very close to achieving victory in state-based GMO labeling campaigns. The very idea that American consumers might find out they’ve been eating GMO poisons in most of their favorite foods is so horrifying to the biotech industry (and the processed food front groups) that its enforcers are now seeking this “nuclear option” to legally deceive consumers about GMOs with the complicity of the FDA.

 

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U.S. bill seeks to block mandatory GMO food labeling by states

April 9 Wed Apr 9, 2014 12:46pm EDT

(Reuters) – A Republican congressman from Kansas introduced legislation on Wednesday that would nullify efforts in multiple states to require labeling of genetically modified foods

The bill, dubbed the “Safe and Accurate Food Labeling Act” was drafted by U.S. Rep. Mike Pompeo from Kansas, and is aimed at overriding bills in roughly two dozen states that would require foods made with genetically engineered crops to be labeled as such.

The bill specifically prohibits any mandatory labeling of foods developed using bioengineering.

“We’ve got a number of states that are attempting to put together a patchwork quilt of food labeling requirements with respect to genetic modification of foods,” said Pompeo. “That makes it enormously difficult to operate a food system. Some of the campaigns in some of these states aren’t really to inform consumers but rather aimed at scaring them. What this bill attempts to do is set a standard.”

Consumer groups have been arguing for labeling because of questions they have both about the safety for human health and the environmental impacts of genetically modified foods, also called GMOs.

Ballot measures in California in 2012 and last year in Washington state narrowly lost after GMO crop developers, including Monsanto Co., and members of the Grocery Manufacturers Association (GMA) poured millions into campaigns to defeat the measures.

The companies say the crops are safe and cite many scientific studies back those claims. Pompeo on Wednesday reiterated those claims, stating GMOS are safe and “equally healthy” and no labeling is needed.

“It has to date made food safer and more abundant,” said Pompeo. “It has been an enormous boon to all of humanity.”

But there are also many scientific studies showing links to human and animal health problems, and many indicating environmental damage related to GMO crops.

 

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Congress considers blocking GMO food labeling

Published time: April 09, 2014 20:10
Edited time: April 10, 2014 11:01
AFP Photo / Robyn Beck

AFP Photo / Robyn Beck

A new bill introduced in Congress looks to ban states from implementing their own labeling laws when it comes to food containing genetically engineered ingredients.

According to Reuters, US Rep. Mike Pompeo (R-Kan.) introduced the legislation on Wednesday, which is intended to head off bills in about 24 states that would require companies to inform customers when their food is produced using genetically modified organisms (GMOs). Titled the “Safe and Accurate Food Labeling Act,” the proposal would forbid states from enacting such proposals.

“We’ve got a number of states that are attempting to put together a patchwork quilt of food labeling requirements with respect to genetic modification of foods,” Pompeo told Reuters. “That makes it enormously difficult to operate a food system. Some of the campaigns in some of these states aren’t really to inform consumers but rather aimed at scaring them. What this bill attempts to do is set a standard.”

Supporters of GMO labeling argue that modified ingredients pose a threat to human health, and that as a result they should be clearly labeled in the marketplace so that consumers can make informed decisions. In addition to health concerns, they also point to the negative environmental consequences that could arise from widespread GMO use, since millions of acres of farmland and weeds are developing resistances to the pesticides used.

Opponents, however, point to their own studies, showing that GMO crops are safe and therefore do not need to be labeled differently than other products.

 

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What the Tamiflu saga tells us about drug trials and big pharma

We now know the government’s Tamiflu stockpile wouldn’t have done us much good in the event of a flu epidemic. But the secrecy surrounding clinical trials means there’s a lot we don’t know about other medicines we take

Tamiflu capsules

Tamiflu capsules. Photograph: Per Lindgren/REX

Today we found out that Tamiflu doesn’t work so well after all. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, finally obtained all the information. Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia.

That is a scandal because the UK government spent £0.5bn stockpiling this drug in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are still routinely and legally being withheld from doctors, researchers and patients. It is simple bad luck for Roche that Tamiflu became, arbitrarily, the poster child for the missing-data story.

And it is a great poster child. The battle over Tamiflu perfectly illustrates the need for full transparency around clinical trials, the importance of access to obscure documentation, and the failure of the regulatory system. Crucially, it is also an illustration of how science, at its best, is built on transparency and openness to criticism, because the saga of the Cochrane Tamiflu review began with a simple online comment.

In 2009, there was widespread concern about a new flu pandemic, and billions were being spent stockpiling Tamiflu around the world. Because of this, the UK and Australian governments specifically asked the Cochrane Collaboration to update its earlier reviews on the drug. Cochrane reviews are the gold-standard in medicine: they summarise all the data on a given treatment, and they are in a constant review cycle, because evidence changes over time as new trials are published. This should have been a pretty everyday piece of work: the previous review, in 2008, had found some evidence that Tamiflu does, indeed, reduce the rate of complications such as pneumonia. But then a Japanese paediatrician called Keiji Hayashi left a comment that would trigger a revolution in our understanding of how evidence-based medicine should work. This wasn’t in a publication, or even a letter: it was a simple online comment, posted informally underneath the Tamiflu review on the Cochrane website, almost like a blog comment.

Tamiflu being made by Roche The UK government spent £0.5bn stockpiling Tamiflu. Photograph: Hanodut/EPA

Cochrane had summarised the data from all the trials, explained Hayashi, but its positive conclusion was driven by data from just one of the papers it cited: an industry-funded summary of 10 previous trials, led by an author called Kaiser. From these 10 trials, only two had ever been published in the scientific literature. For the remaining eight, the only available information on the methods used came from the brief summary in this secondary source, created by industry. That’s not reliable enough.

This is science at its best. The Cochrane review is readily accessible online; it explains transparently the methods by which it looked for trials, and then analysed them, so any informed reader can pull the review apart, and understand where the conclusions came from. Cochrane provides an easy way for readers to raise criticisms. And, crucially, these criticisms did not fall on deaf ears. Dr Tom Jefferson is the head of the Cochrane respiratory group, and the lead author on the 2008 review. He realised immediately that he had made a mistake in blindly trusting the Kaiser data. He said so, without defensiveness, and then set about getting the information needed.

First, the Cochrane researchers wrote to the authors of the Kaiser paper. By reply, they were told that this team no longer had the files: they should contact Roche. Here the problems began. Roche said it would hand over some information, but the Cochrane reviewers would need to sign a confidentiality agreement. This was tricky: Cochrane reviews are built around showing their working, but Roche’s proposed contract would require them to keep the information behind their reasoning secret from readers. More than this, the contract said they were not allowed to discuss the terms of their secrecy agreement, or publicly acknowledge that it even existed. Roche was demanding a secret contract, with secret terms, requiring secrecy about the methods and results of trials, in a discussion about the safety and efficacy of a drug that has been taken by hundreds of thousands of people around the world, and on which governments had spent billions. Roche’s demand, worryingly, is not unusual. At this point, many in medicine would either acquiesce, or give up. Jefferson asked Roche for clarification about why the contract was necessary. He never received a reply.

Then, in October 2009, the company changed tack. It would like to hand over the data, it explained, but another academic review on Tamiflu was being conducted elsewhere. Roche had given this other group the study reports, so Cochrane couldn’t have them. This was a non-sequitur: there is no reason why many groups should not all work on the same question. In fact, since replication is the cornerstone of good science, this would be actively desirable.

Then, one week later, unannounced, Roche sent seven documents, each around a dozen pages long. These contained excerpts of internal company documents on each of the clinical trials in the Kaiser meta-analysis. It was a start, but nothing like the information Cochrane needed to assess the benefits, or the rate of adverse events, or fully to understand the design of the trials.

Packets of Tamiflu Packets of Tamiflu in a drawer at a German pharmacy. Photograph: Wolfgang Rattay/Reuters At the same time, it was rapidly becoming clear that there were odd inconsistencies in the information on this drug. Crucially, different organisations around the world had drawn vastly different conclusions about its effectiveness. The US Food and Drug Administration (FDA) said it gave no benefits on complications such as pneumonia, while the US Centers for Disease Control and Prevention said it did. The Japanese regulator made no claim for complications, but the European Medicines Agency (EMA) said there was a benefit. There are only two explanations for this, and both can only be resolved by full transparency. Either these organisations saw different data, in which case we need to build a collective list, add up all the trials, and work out the effects of the drug overall. Or this is a close call, and there is reasonable disagreement on how to interpret the trials, in which case we need full access to their methods and results, for an informed public debate in the medical academic community.

This is particularly important, since there can often be shortcomings in the design of a clinical trial, which mean it is no longer a fair test of which treatment is best. We now know this was the case in many of the Tamiflu trials, where, for example, participants were sometimes very unrepresentative of real-world patients. Similarly, in trials described as “double blinded” – where neither doctor nor patient should be able to tell whether they’re getting a placebo or the real drug – the active and placebo pills were different colours. Even more oddly, in almost all Tamiflu trials, it seems a diagnosis of pneumonia was measured by patients’ self-reporting: many researchers would have expected a clear diagnostic algorithm, perhaps a chest x-ray, at least.

Since the Cochrane team were still being denied the information needed to spot these flaws, they decided to exclude all this data from their analysis, leaving the review in limbo. It was published in December 2009, with a note explaining their reasoning, and a small flurry of activity followed. Roche posted their brief excerpts online, and committed to make full study reports available. For four years, they then failed to do so.

 

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Row erupts over influenza drug Tamiflu

Tamiflu is on the World Health Organisation's 'essential medicines' list (Flickr: kanonn)

Tamiflu is on the World Health Organisation’s ‘essential medicines’ list (Flickr: kanonn)

Governments who stockpile the anti-flu medicine Tamiflu are wasting billions of dollars on a drug whose effectiveness is in doubt, according to a new study.

The row has drawn in the drugmaker Roche, as well as industry regulators and independent scientists. Supporters of Tamiflu says the review’s conclusions are flawed and insiste the drug is both safe and effective.

The dispute over the benefits of Tamiflu, and to a lesser extent of GlaxoSmithKline’s flu drug Relenza, blew up with the joint publication by the respected Cochrane Review research network and the British Medical Journal of an analysis of trial data, which found no good evidence behind claims the drugs cut hospital admissions or reduce flu complications.

The review’s main findings were that the medicines had few if any beneficial effects, but did have adverse side effects that were previously dismissed or overlooked.

“Remember, the idea of a drug is that the benefits should exceed the harms,” says Carl Heneghan, one of the lead investigators of the Cochrane review and a professor of evidence-based medicine at Britain’s Oxford University. “So if you can’t find any benefits, that accentuates the harms.”

But Roche, which has been under fire for several years over its refusal to allow the Cochrane team unrestricted access to Tamiflu data, rejected the findings, saying it “fundamentally disagrees with the overall conclusions” of their study.

“We firmly stand by the quality and integrity of our data, reflected in decisions reached by 100 regulators across the world and subsequent real-world evidence demonstrating that Tamiflu is an effective medicine in the treatment and prevention of influenza,” it says in a statement.

Tamiflu sales hit almost $3 billion in 2009 — mostly due to its use in the H1N1 flu pandemic — but they have since declined.

The drug, one of a class of medicines known as neuraminidase inhibitors, is approved by regulators worldwide and is stockpiled in preparation for a potential global flu outbreak. It is also on the World Health Organisation’s “essential medicines” list.

 

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young sick Americans Living Sick and Dying Young in Rich America

 

Health Impact News Editor Comments

When I read an article in The Atlantic recently with the title: Living Sick and Dying Young in Rich America - Chronic illness is the new first-world problem – it caught my attention. This is the kind of topic we cover on a regular basis here at Health Impact News, but seldom do you read about it in the mainstream media.

There are 3 things that are rather astonishing about the sad state of health in America today:

1. We’re sicker than previous generations, and most of us know it.

2. We don’t seem to care about it too much. It is not headline news.

3. There doesn’t seem to be much motivation to change this fact: it seems to have been accepted as the new “norm.”

Last year, we reported about a study funded by the government and your tax dollars which clearly showed that the United States ranks #1 on healthcare spending, but last in life expectancy among wealthy nations (See: U.S. Ranks First in Healthcare Spending – Last in Life Expectancy). The mainstream media barely even covered this story, and even here at Health Impact News it was probably not even in the top 100 stories read from everything we published last year.

The sad fact seems to be that most Americans have adopted an attitude that the current health situation in the U.S. cannot be changed.

For those few of you who have not drunk the Kool Aid, and still believe you do have control over your health and have choices you can make to live a healthier life, then this article by John Thomas identifying the problems and solutions is for you.

Please understand that if enough Americans understand that the healthcare system (which is not really a “healthcare” system at all but a MEDICAL system) is the primary problem and take measures to avoid it, that it would absolutely destroy our economy, since so much of it is dependent on sick people. But maybe our economy is heading for destruction anyway, so don’t let that threat stop you from making healthy choices today.

Is it Normal to be Sick?

by John P. Thomas

Is it normal to be sick? Many people think so, but it hasn’t always been this way. What was life like before we became dependent on modern pharmaceutical drugs, major medical centers, and health insurance? If we turn back the clock a hundred and fifty years, we will hardly find anything that looks like the modern medical system. Did previous generations live in the dark ages of medicine, or is the modern age of chronic degenerative illness and modern pharmaceutical drugs actually a dark age of medicine?

I remember overhearing a conversation while waiting for a table in a restaurant some 25 years ago. A grandmother was talking to her 10 year old grandson. She must not have seen him for a while, so she began by asking one of those general types of questions to get the conversation started. “How are you feeling?” Without hesitation, her grandson started discussing his various health problems, which included allergies, asthma, fatigue, etc. In a grandmotherly voice filled with sympathy and concern, she gave a reply that sticks in my mind to this day.  She said, “I understand — we all have something wrong with us.” She went on to tell him that we are all sick and we have to learn to live with it. I don’t know if her words were entirely true then, but they are most certainly true today! We are sick and getting sicker, and we are all being taught to live with it.

Here we are 25 years later and despite all the medical and pharmaceutical advances that have taken place in the United States, we are sicker than ever. How many people do you know who are not taking one or more prescription medications? How many people do you know who do not have a medical diagnosis for some chronic illness? How many people do you know who are not being treated for some condition that requires periodic trips to the doctor to monitor disease progression and to adjust medications? How many people do you know who struggle with paying for medications? If I count the people I know, who do not fall into the groups I just mentioned, I can count them on the fingers of one hand. How about the people you know?

The purpose of this article is to examine how we respond to our illnesses and to questions whether our pharmaceutical drugs and system of healthcare is making us sicker than we need to be.

Does the Healthcare System in the United States Lead the World?

We certainly lead the world in the amount of dollars spent on healthcare. We spend 2.5 times more per person per year than is spent in any other country on Earth for healthcare.1

Does the Money we Spend for Healthcare Make Us the Healthiest people in the World?

The New York Times recently revealed how our healthcare system compares to other countries.

“In the Social Progress Index, the United States excels in access to advanced education but ranks 70th in health, 69th in ecosystem sustainability, 39th in basic education, 34th in access to water and sanitation and 31st in personal safety.”2

The United States is sitting in the 70th position down from the top of the list for the category of health when compared to other countries. Let’s look at the details of how we compare to other wealthy countries.

The Panel on Understanding Cross-National Health Differences Among High-Income Countries, compared the health of people living in the United States with people living in other high income countries, which included Australia, Austria, Canada, Denmark, Finland, France, Germany, Italy, Japan, Norway, Portugal, Spain, Sweden, Switzerland, the Netherlands, and the United Kingdom. They reported:

Over this time period, we uncovered a strikingly consistent and pervasive pattern of higher mortality and inferior health in the United States, beginning at birth: … For many years, Americans have had a shorter life expectancy than people in almost all of the peer countries. For example, as of 2007, U.S. males lived 3.7 fewer years than Swiss males and U.S. females lived 5.2 fewer years than Japanese females.3

We have the most expensive healthcare system in the world, which should make us the healthiest people on Earth, but this is not the case.

Why are We so Sick?….

 

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Expensive pills
March 29, 2014

There is a little known bill in the works which would force people in crisis into forced psychiatric treatment. Mad in America reported on March 28, 2014 that mental health advocates are urging protest against a forced treatment addition to a new Medicare bill. Many national mental health and disability advocacy groups have joined together to urge people to contact their senators in order to protest a section of a bill which was rushed through the House of Representatives by voice vote this week. This bill, Section 224 of HR4302, is up for a vote in the Senate on Monday.

Raymond Bridge, public policy director of the National Coalition for Mental Health Recovery has said: “In its rush to fix a problem with Medicare, the House passed a bill including a highly controversial program, involuntary outpatient commitment, with no debate and no roll call vote.” It appears to Bridge that the Senate may pass a version of the House bill which includes this troublesome provision on Monday. Daniel Fisher, M.D., Ph.D. has commented about this bill, saying: “It would bring America back to the dark ages before de-institutionalization, when people with mental health conditions languished in institutions, sometimes for life.”

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Mental Health Advocates Decry Forced Treatment Provision in “Doc Fix” Bill

 

WASHINGTON, March 28, 2014 /PRNewswire-USNewswire/ — The bill rushed through the House of Representatives by voice vote yesterday to patch Medicare regulations includes a highly controversial provision that has nothing to do with Medicare, and that would subject people in crisis to forced treatment. Studies have shown that such force causes trauma and drives people away from treatment, mental health advocates warned.

Today, an array of national mental health and disability advocacy groups joined together to decry this provision, which they view as a regressive attack on hundreds of thousands of Americans with serious mental health conditions.

“In its rush to fix a problem with Medicare, the House passed a bill including a highly controversial program, involuntary outpatient commitment, with no debate and no roll call vote,” said Raymond Bridge, public policy director of the National Coalition for Mental Health Recovery (NCMHR), a coalition of 32 statewide organizations and others representing individuals with mental illnesses. “And it seems that the Senate may pass a version of the House bill including this troubling provision on Monday,” Bridge added.

The 123-page Protecting Access to Medicare Act of 2014, H.R. 4302, includes a four-year, $60 million grant program (Sec. 224) to expand involuntary outpatient commitment (IOC) – also called Assisted Outpatient Treatment (AOT) – in states that have laws authorizing IOC. The laws allow courts to mandate someone with a serious mental illness to follow a specific treatment plan, usually requiring medication. The facts show that involuntary outpatient commitment is not effective, involves high costs with minimal returns, is not likely to reduce violence, and that there are more effective alternatives.

Assisted Outpatient Treatment is central to the controversial Helping Families in Mental Health Crisis Act (H.R. 3717), proposed by Rep. Tim Murphy in December 2013.

“This legislation would eliminate initiatives that use evidence-based, voluntary, peer-run services and family supports to help people diagnosed with serious mental illnesses to recover,” said Daniel Fisher, M.D., Ph.D., a psychiatrist and an NCMHR founder. “It would bring America back to the dark ages before de-institutionalization, when people with mental health conditions languished in institutions, sometimes for life.”

The provisions of H.R. 3717 would exchange low-cost, community-based services with good outcomes for high-cost yet ineffective interventions, according to the NCMHR; the National Disability Rights Network (NDRN), the non-profit membership organization for the federally mandated Protection and Advocacy (P&A) Systems and Client Assistance Programs (CAP) for individuals with disabilities; and the National Council on Independent Living (NCIL), which advances independent living and the rights of people with disabilities through consumer-driven advocacy.

 

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Young cancer survivor will get experimental treatment

A 7-year-old boy who has beaten cancer four times but whose weakened immune system is being threatened by a rare virus will start receiving an experimental treatment within 48 hours after the drug’s manufacturer reached an agreement with federal officials for a pilot trial to begin immediately.

The boy, Josh Hardy, will be the first patient to be enrolled Wednesday in the new study of the drug, brincidofovir, the Durham, N.C.-based company, Chimerix, announced late Tuesday.

Earlier the company had said it could not release the drug to Josh outside of clinical trials. The boy’s family had been pleading with the company to change its mind.

1904169-667793373261832-408634175-n.jpg

Josh Hardy is seen in this undated photo from the SaveJosh Facebook page. Used with permission from William Burns
Personal photo

The U.S. Food and Drug Administration agreed to the pilot trial of brincidofovir for the treatment of adenovirus infections in immune-compromised patients, the company said in a statement late Tuesday. The FDA will work expeditiously with Chimerix to design a Phase 3 study that would be a continuation of the pilot trial, the company said.

“Josh Hardy’s story brought to public attention the often-devastating impact of adenovirus infection, and helped accelerate a discussion between the FDA and Chimerix regarding the need for additional clinical development to assess brincidofovir’s potential in adenovirus infection,” Kenneth I. Moch, Chimerix’s president and CEO, said in a statement.

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FORBES

Matthew Herper Forbes Staff

Pharma & Healthcare 3/11/2014 @ 9:12PM 4,486 views

Company Makes Drug Available To Ailing Boy Following Public Outcry

Chimerix, a small and unprofitable biotechnology company, will make an experimental drug available to a young Virginia boy who is suffering from an infection he contracted while being treated for cancer.

Chimerix originally said it could not ethically provide the drug to one patient without opening the floodgates to others, presenting it with a huge operational burden that might prevent the drug, brincidofovir, from ever reaching patients. The story of the boy, Joshua Hardy, was shared on CNN, USA Today, The Huffington Post, and generated a large volume of posts on the social networking site Twitter under the hashtag #savejosh. This evening, Chimerix, based in Durham, North Carolina, issued a press release saying that it was going to start a new, 20-patient clinical trial for the treatment of adenovirus (the virus brincidofovir treats) in immunocompromised patients. The first immunocompromised patient, dosed tomorrow morning, will be Josh Hardy.

“This 20-patient open-label study underscores Chimerix’s mission to develop innovative antiviral therapies in areas of high unmet need – for everyone,” said Chimerix Chief Executive Kenneth I. Moch in his company’s press release. “Being unable to fulfill requests for compassionate use is excruciating, and not a decision any one of us ever wants to have to make. It is essential that each individual in a health crisis be treated with equal gravity and value, a principle we have upheld by pursuing further clinical study of brincidofovir that will inform its use in adenovirus and other serious DNA viral infections.”

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Breaking News: FDA’s Sneak Attempt to Ban Another B Vitamin

March 11, 2014

Vitamins Close-upYou can’t live without this vitamin. But the FDA wants to reserve the natural form for monopoly drug companies, leaving only the synthetic form for supplements. Urgent Action Alert!

 

The FDA has just released a new 109-page guidance on the revision of nutrition and supplement labels. (You can read more about the implications of the new labeling rules in our other article this week.)

 

On page 69, the agency slipped in two little paragraphs that could risk the health of millions of people who desperately need folate. It’s a sneak attack so quiet and unobtrusive that few people will even realize it’s there.

 

According to the guidance, the word “folate” will be banned from the Supplement Fact labels—only the term “folic acid” will be allowed.

 

Folate is the naturally occurring form of the water-soluble vitamin B9. It is found in foods such as black-eyed peas, chickpeas and other beans, lentils, spinach, turnip greens, asparagus, avocado, and broccoli, but is also available as a supplement.

 

The human body needs folate to synthesize and repair its DNA. It’s especially important during the kind of rapid cell division and growth seen in infancy and pregnancy. Children and adults both require folate to produce healthy red blood cells and prevent anemia among many other vital functions.

 

Folic acid, on the other hand, is synthetically produced, and refers to just one member of the folate group: pteroylmonoglutamic acid. While folic acid occurs only rarely in whole foods, it’s extremely stable, which is why it’s widely used in dietary supplements and to fortify processed foods.

 

The important thing to remember is that folic acid is not itself biologically active, though for most people the liver can convert it to the folate we need. Most, however, does not mean all. It’s estimated that 30% to 40% of the population can’t efficiently convert synthetic folic acid into folate.

 

In other words, about a third of the human population has two potential problems: a deficiency in folate (because it is hard to get enough from a diet full of processed foods), and possibly even an excess of folic acid (because their body can’t metabolize what could become an overabundance of folic acid present in “fortified” foods):

 

  • According to Dr. Jonathan V. Wright, folate deficiency is one of the most dangerous medical conditions, leading to Alzheimer’s and other brain diseases. If pregnant women are deficient in it, it can also lead to spina bifida and other neural tube birth defects in their children.

 

 

Note that the FDA is not exactly banning the inclusion of folate and requiring the inclusion of folic acid in supplements. As usual, it is playing a much more subtle insider’s game. It is simply banning supplement producers from using the word folate on their labels and conversely only allowing the word folic acid on their labels. But it would of course be fraudulent to put folic acid on your label and then use something else. The FDA understands that perfectly.

 

So on what grounds is the agency banning the use of the word folate on the label? Believe it or not, it is arguing that folate can only be found in “conventional” (whole or minimally processed) foods.

 

Before we examine this absurd claim, we must first explain that limiting a folate claim to food would not prevent drug companies from becoming the only source of folate outside of food. Drug companies don’t care what a chemical is called so long as they can create a high priced monopoly in it. Ironically, the FDA’s position that folate can only be used to describe what is in food would still turn folate over to the drug companies—so long as supplement labels can only use the term folic acid.

 

So what about the agency’s assertion that “folate” can only be found in food? “Folate” is actually a term for a whole B vitamin group. The term “folate” we see on dietary supplement labels refers to “dietary folates,” members of the folate group that can be naturally found in foods. Folinic acid (5-FTHF), calcium methylfolate, and various other tetrahydrofolates can be found in dietary supplements. Many brands feature dietary folate.[1] It would be completely inaccurate and misleading to refer to these dietary folates as “folic acid.” Legally, it would be fraudulent.

 

Why did the FDA do this? One can only guess. But it would not be surprising if it eventually turns out to be a blatant attempt to reserve for drug companies the use of dietary folates. After all, B vitamins are not only essential for life. They are also proven therapeutic agents. Drug company research programs have been coming up short for years; new drug therapeutic agents are in very short supply.

 

Moreover, the drug company Merck already holds patents on Metafolin, which the body recognizes as a bioavailable dietary folate. Metafolin is licensed by dietary supplement companies for some of their products.

 

If, according to FDA “logic,” dietary supplements can’t contain folate like Metafolin, it would only be available from whole foods…or drugs, and only from drugs in higher doses. Since Merck would have exclusivity for a Metafolin “drug,” our guess is that they would make billions. And other forms of patentable folate could then follow.

 

Sound unlikely? It’s not—both forms of fish oil and vitamin D have already been turned into patented drugs. Imagine if competition from supplemental forms of fish oil or D could be wiped out at one stroke by saying no supplement label could use the term!

 

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Anthony Gucciardi

Published on Mar 8, 2014

Anthony Gucciardi joins The Alex Jones Show to discuss the militarization of government wings, how small businesses are being targeted, and much more.

 

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Business Insider  Science

There Might Be A Big Corruption Scandal Surrounding America’s Dangerous New Painkiller

FDA Commissioner Margaret Hamburg

AP

FDA Commissioner Margaret Hamburg

Ever since a coalition of doctors came out against the controversial new painkiller Zohydro, health officials have been questioning how the drug got approved by the Food and Drug Administration in the first place.

Now, two senators are questioning the ethics of a series of meetings between drug companies and federal regulators, MedPage Today reports.

Senators Joe Manchin (D-W.Va.) and David Vitter (R-La.) want answers about what they call “pay-to-play” meetings in which pharmaceutical manufacturers allegedly shelled out thousands of dollars to meet with FDA officials who oversee safety regulations on painkillers. The senators suggest these meetings might have helped Zohydro get approved by the FDA despite an advisory committee voting against it.

 

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Healthy Living

 

 

 

 

Prenatal Tylenol Use Linked to ADHD in Baby

 

More often than not, a woman’s first prenatal visit comes with a lot of dos and don’ts. What to eat. What not to eat. When to exercise. How to exercise. And most importantly, which over-the-counter medications are safe to take in the event of minor ailments like an upset stomach or a headache.

 

Until recently, that list banned ibuprofen but approved acetaminophen (the main ingredient in Tylenol) for reducing fevers, and relieving minor aches and pains.

 

But a new study may have health experts thinking twice about that list as it found that the children of women who took Tylenol during pregnancy were 40 percent more likely to be diagnosed with attention deficit hyperactivity disorder – or ADHD- than children of mothers who did not.

 

The likelihood of a child developing ADHD increased the most – by 63 percent – when the acetaminophen was taken during the last two trimesters of pregnancy. When it was used in the third trimester alone, researchers found an increased in ADHD of about 28 percent. The risk was smallest – about nine percent – when the pregnant woman only used the medication during her first trimester of pregnancy.

 

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