Day: 05/29/2013

Front Groups Exposed—50 Industry Groups Form a New Alliance to Manipulate Public Opinion About Junk Food, GMOs, and Harmful Additives.

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atrazine

Story at-a-glance

  • The United Nations established the Codex Alimentarius Commission in 1962. Usually referred to as “Codex,” it consists of approximately 170 member countries that set food guidelines and standards for the world.
  • Over the years, Codex has been embroiled in controversy for a number of reasons, but now our investigations show that Monsanto―one of the world’s largest producers of genetically-modified seeds― is behind a significant number of front groups that control Codex policy.
  • Most recently, more than 50 industry trade groups formed a new alliance called Alliance to Feed the Future. These groups represent multi-national food-, biotech-, and chemical companies that generate hundreds of billions of dollars-worth of revenue each year
  • Alliance to Feed the Future claims its purpose is to “balance the public dialogue” on modern agriculture and large-scale food production and technology. Or, in other words, they aim to become the go-to source for “real” information about the junk being sold as “food”
  • The Kellen Company is instrumental in creating and managing front groups for the processed food and chemical industries. These front groups are specifically created to mislead you about the product in question, protect industry profits, and influence regulatory agencies

 

If you think it’s tough sorting truth from industry propaganda and lies, get ready for even tougher times ahead. More than 50 front groups, working on behalf of food and biotechnology trade groups―Monsanto being the most prominent―have formed a new coalition called Alliance to Feed the Future.

The alliance, which is being coordinated by the International Food Information Council (IFIC), was created to “balance the public dialogue” on modern agriculture and large-scale food production and technology, i.e. this group will aim to becomethe go-to source for “real” information about the junk being sold as “food.”

The groups comprising this new alliance represent multi-national food companies,biotech industry, and chemical companies that generate hundreds of billions of dollars worth of revenue from food related sales every year.

On the upside, this alliance and many other industry-sponsored front groups masquerading as non-profits and consumer protection organizations are becoming increasingly exposed for what they really are, and I will point out several of them in this article.

Michele Simon, JD, MPH, policy consultant with Center for Food Safety recently published a report titled: Best Public Relations Money Can Buy: A Guide to Food Industry Front Groups1 also reveals how the food and agricultural industryhide behind friendly-sounding organizations aimed at fooling the public, policymakers and media alike.

Many Industry Front Groups Are Created to Dominate Codex Discussions

The Codex Alimentarius Commission, conceived by the United Nations in 1962, was birthed through a series of relationships between the World Health Organization (WHO), the Food and Agriculture Organization (FAO), the World Trade Organization (WTO) as well as the American FDA and USDA.

The Codex Alimentarius itself is a compilation of food standards, codes of practice and guidelines that specify all requirements related to foods, whether processed, semi-processed, genetically engineered, or raw.

Its purported purpose is to “protect consumers’ health, ensure fair business practices within the food trade, and eliminate international food trade barriers by standardizing food quality.”

There are a number of different working groups that meet regularly to establish food standards of every imaginable kind. For example, the Physical Working Group on Food Additives recently held meetings in Beijing, China. The 45th session of the Codex Committee on Food Additives (CCFA) ended on March 22.

On the agenda were discussions about aluminum-containing food additives. Are they safe or should they be eliminated from the worldwide Codex standards? The National Health Federation (NHF), the only health-freedom group allowed to speak at the meeting, dished out harsh criticism on the additives, calling for their removal. In a Facebook update, the NHF wrote:2

“The usual Codex suspects (the delegations of Australia, the United States and Canada) plus the trade organizations of the International Food Additives Council (IFAC) and the International Council of Grocery Manufacturers Associations (ICGMA) were the industry apologists for keeping aluminum in food additives.

In dishing out scorching criticism of aluminum’s proponents, NHF came under return fire from Australia, IFAC, and the Chairman.

IFAC – which does not seem to disclose any of its members… along with its sidekick ICGMA, cried out constantly that the ‘Industry’ just could not make it without aluminum food additives. Their members spraying equipment ‘might overheat and catch fire,’ IFAC lamented.

When NHF suggested that this was a not a genuine issue; that the industry could easily innovate its way out of this ‘problem’ and create non-overheating equipment, NHF was criticized by the Chairman for suggesting that IFAC might not be telling the truth.

By the end of the day, the success of the EU and NHF could be tallied by numerous uses of aluminum food additives that the Working Group will suggest be discontinued to the full Committee meeting… although there were also many food-additive uses that stayed in place (albeit usually at reduced levels), no thanks to the interventions of Australia, the U.S., Canada, IFAC, and ICGMA.”

Who’s Behind the International Food Additives Council (IFAC)?

The International Food Additives Council (IFAC) is “an international association representing companies that produce high quality substances used worldwide as food ingredients in traditional and organic products.” The group is very active in Codex. But how do you know who they are, and who they represent, when it’s almost impossible to find out who their members are?

As the NHF noted above, it’s virtually impossible to locate a list of its members (which naturally would indicate sources of funding, and potentially reveal behind-the-scenes agendas).

But here, I’m making public IFAC’s list of officers and board members as of 2011. It wasn’t easy to find this list, primarily because IFAC isn’t a regular 501(c)(3). In fact, it isn’t a 501(c)(3) at all. Actually, it’s a 501(c)(6)―an IRS classification for nonprofit “commercially oriented” organizations such as football leagues, chambers of commerce and, apparently, groups like IFAC. Once you know its non-profit classification, you can find its 990 forms―which all non-profits must file, complete with lists of officers and directors. I obtained IFAC’s 990s for the years 2004-2011. And there I learned the truth.

Except for two, who I couldn’t find any information at all on, all of IFAC’s officers and directors are linked to processed foods and additives in some way, with at least six of them having direct or business links to Monsanto and/or DuPont. That’s right. Six of IFAC’s governing board members are linked to the largest GMO producers in the world.

If you look up these board members’ contact information, you’ll find that all contacts for IFAC3 go to a corporation called The Kellen Company. Kellen “provides the essential services to advance associations to the next level of their evolution.” Such services include management, administration, accounting, meeting planning, membership marketing and strategic advice. According to the company’s website:

“Kellen takes the mission and message of each association client and brings it to audiences large and small, internal and external, domestic and international. Utilizing communications tools that are customized for each association, Kellen identifies the audiences, develops the strategies, defines the tactics and executes a planned and carefully reasoned communications plan.”

“Our consulting expertise enables us to reorganize association governance and assets, optimize association resources, extend reach for U.S. associations into Europe and Asia… Kellen’s team is expert in all strategic and tactical elements of associations and can provide insightful analysis and guidance on industry alignment… establishing new legal entities and building consensus. “ [Emphasis mine]

Additionally, if you look up IFAC’s origins in Internet business profiles, you’ll find that it was formed in 1980 by Patrick M. Farrey, who just so happens to be The Kellen Company’s group vice president. In short, The Kellen Company not only is linked to the formation of IFAC, but also serves as the managing entity behind IFAC. And its members, although a proper members list has not been obtained, are bound to be like their governing body― manufacturers of food additives, including but certainly not limited to manufacturers of artificial sweeteners and glutamate (i.e. MSG).

This association is clearly spelled out in the Council’s name. But what’s troublesome about it is that IFAC represents companies that create food ingredients in organic products as well, although there’s not a shred of evidence that any person, company or organization dedicated to organics is actually represented by IFAC. If that is the case, this means IFAC probably does NOT have any incentive at all to ensure such ingredients are appropriate for organic products, and most likely, they will just do what needs to be done to ensure its members’ ingredients are allowed to be used in organics no matter what.

You need look no further than its board members―and their links to Monsanto and DuPont, and their managing entity, Kellen―to see what I’m talking about, because Kellen tells you plainly on its website where the organization it represents stand when it comes to organics. Boasting that Kellen and its members joined the “Say No to Proposition 37” movement in California, Kellen explains right on its website how they defeated the bill that would have mandated that all GMO products be labeled as such:

“Almost all of Kellen Company’s food clients would have been negatively affected by Prop. 37, but no single association was in a position to lead opposition efforts to GMO labeling. A coalition was a perfect solution; our team decided to join the ‘No on 37 Coalition,’ a multi-stakeholder group that led opposition efforts and helped to educate Californian voters about the shortcoming of Prop. 37. And that story has a happy ending – the proposition was not passed and food companies in California are not required to include potentially misleading labeling.”

The site goes further, detailing the steps to “success” of this campaign, advising site visitors: “With proposed ballot initiatives beginning to be certified and many states opening their 2013 legislative sessions this month, now is the time to think about your association’s plans should state legislation or a ballot initiative affecting your industry be introduced in 2013.”

Finally, if you have any doubt about what IFAC’s goals are, you need look no further than a PowerPoint presentation4 that the group is currently giving at symposia and conventions around the world. One of the slides on this presentation states that IFACpromotes “independently determined” studies of safety in its members’ products. By “independent,” they explain that this means: “experts chosen and employed by the manufacturer.” This is the same procedure that gets Monsanto’s products to market: Monsanto gets to do its own safety studies and submit them to the FDA as “proof” that their products won’t harm you.

Front Groups Working to Keep Harmful Food Additives Hidden and on the Market

The Kellen Company has ties with other major industry players. According to a 2011 press release,5 one of the Kellen Company executives was honored as president of the Calorie Control Council, a non-profit association that represents manufacturers and suppliers of low-calorie, sugar-free and reduced sugar foods and beverages. It’s also closely tied to the International Council of Grocery Manufacturers Associations (ICGMA), which, along with IFAC, urged the Codex working group to keep aluminum in food additives, despite the many known health risks associated with aluminum.

According to Truthinlabeling.org,6 there are a number of front groups for the glutamate and artificial sweetener industry in the US. In an article titled: Meet the people who get the job done so effectively, they write:

“In the United States, the glutamate industry has two arms. Both work to keep MSG hidden in food. One is the International Hydrolyzed Protein Council… The second and more active arm is spearheaded by Ajinomoto’s International Glutamate Technical Committee (IGTC) and its American subsidiary, The Glutamate Association (TGA), with representative organizations throughout the world.”

Now here’s where it gets interesting, as it again shows the intricate ties of the glutamate industry with the Kellen Company:

“In 1977, the IGTC spun off The Glutamate Association, with both organizations accommodated under the umbrella of The Robert H. Kellen Company… a trade organization and association management firm, specializing in the food, pharmaceutical, and health care industries. [Editor’s note: although not covered in this article, this is a clue that there are many front groups operating in the drug and health care industry as well, under the careful management of the Kellen Company. Such front groups ensure you will NOT get the truth about drugs and health care issues where corporate profits are at stake.]

The Encyclopedia of Associations (The Glutamate Association, 1990) listed Robert H. Kellen as president of The Glutamate Association. Richard Cristol, executive director of The Glutamate Association, was also Vice President of The Kellen Company. Cristol assumed management of the Washington, DC operations of The Kellen Company and its subsidiary, HQ Services, in 1993…

In 1992, and still in 1998, Andrew G. Ebert, Ph.D., Chairman of the International Glutamate Technical Committee (IGTC), was also Senior Vice President of The Kellen Company. Membership in The Glutamate Association is secret. However, a source from within the glutamate industry, who asked to remain anonymous, told us that besides Ajinomoto, Archer Daniels Midland, Campbell, Corn Products Corporation, McCormick & Company, Pet Foods, Pfizer Laboratories, and Takeda were among its members; and Nestle was a former member.”

The fact that membership is a secret is telling in and of itself, and it’s quite ironic, considering the Glutamate Association is ardently working to keep the presence of glutamate in foods and other products, such as fertilizers and growth promoters, hiddenfrom the consumer… But there’s more. I’ve often discussed the revolving door between the US Food and Drug Administration, and here we see the door swinging yet again. According to another article by TruthInLabeling.org:7

“Influence of the International Glutamate Technical Committee (IGTC) can be felt at every level. [Andrew G.] Ebert has served the Grocery Manufacturers of America; the National Food Processors Association; the Institute of Food Technology; the National Research Council of the National Academy of Sciences Assembly of Life Sciences; theAmerican Medical Association; the FAO/WHO Codex Alimentarius Food Standards Program as an Industry Observer; and the International Food Additives Council (IFAC) as Executive Director. In 1992, FDA appointed both Andrew G. Ebert, Ph.D., IGTC chairman, and Kristin McNutt, Ph.D., paid spokesperson for the IGTC, to the FDA Food Advisory Committee.” [Emphasis mine]

At this point, it would appear The Kellen Company is instrumental in creating and managing front groups for the processed food and chemical industries. These front groups are specifically created to mislead you about the product in question, protect industry profits, and influence regulatory agencies. This amount of collusion simply is not necessary for a food or product that is truly safe and has great intrinsic value, but it must be done for inferior and/or dangerous products that cannot stand up to closer scrutiny by truly independent sources.

What’s more, it appears all these front groups (there are many others not specifically mentioned in this article) have been created in order to have more seats at the Codex meetings, essentially giving chemical companies and major food manufacturers a much louder voice, in order to control the decisions made.

Front Man Steven Milloy, and Other Non-Profit Front Organizations with Ties to Industry

Steven Milloy, author of Green Hell: How Environmentalists Plan to Control Your Life and What You Can Do to Stop Them, and owner and operator of Junkscience.com8 — a site dedicated to denying environmental and health concerns related to pollutants and chemicals, including those used in agriculture and food production — appears to have been registered as a lobbyist with The EOP Group, a lobbying firm based in Washington, DC. Clients of the firm have included the American Crop Protection Association, the Chlorine Chemistry Council, and Edison Electric Institute.9

Milloy’s clients10 included both Monsanto and the International Food Additives Council (IFAC). Milloy has denied ever being a lobbyist, claiming that he was “a technical consultant” for the lobbying firm.

“However, Milloy shows up in federal lobbyist registration data for 1997 as having lobbying expenditures on his behalf, indicating his firm, the EOP Group, believed him to be an active lobbyist, ‘technical’ or otherwise,” TRWNews11 states in its expose of the industry front man.

Milloy also headed up the now defunct corporate front group, The Advancement of Sound Science Coalition (TASSC). According to TRWNews,12 TASSC and the Junkscience.com site were one and the same. Integrity in Science,13 which lists non-profit organizations with close ties to industry, reports that TASSC received financial support from hundreds of corporations, including the likes of Procter & Gamble, Exxon, Dow Chemical, and Philip Morris. I’ll leave it up to you to guess what kind of ‘sound science’ was advanced by those sources…

“Its objective is to act as a speakers bureau to deliver the corporate message that environmental public policy is not currently based on ‘sound science,’ and to counter excessive regulations that are based on what it considers ‘junk’ science,” Integrity in Science states. [Emphasis mine]

Other non-profit organizations that are in actuality doing the bidding of various industry giants include:

  • Air Quality Standards Coalition, “created specifically to battle the clean air proposals, the coalition operates out of the offices of the National Association of Manufacturers, a Washington-based trade group. Its leadership includes top managers of petroleum, automotive and utility companies”
  • Alliance for the Prudent Use of Antibiotics, while sounding like it would work for your benefit, actually gets “unrestricted grants” from a long list of pharmaceutical companies
  • Alliance to Save Energy, which “supports energy efficiency as a cost-effective energy resource under existing market conditions and advocates energy-efficiency policies that minimize costs to society and individual consumers,” was founded by, among others: BP…
  • American Academy of Pediatrics receives $1 million annually from infant formula manufacturers. Other donors include (but is not limited to) the National Cattlemen’s Beef Association, Johnson & Johnson Consumer Products, both Wyeth’s and Merck’s vaccine divisions, the Food Marketing Institute, the Sugar Association, and the International Food Information Council (IFIC) — which you will see below, is not only a front group for the glutamate industry; it’s also the coordinating agent for a new alliance of over 50 industry groups aimed at directing the dialogue and altering public opinion about large-scale, genetically engineered and chemical-based food production
  • American Council for Fitness and Nutrition. This one takes the cake with a member list that includes the American Bakers Association, the American Meat Institute, the Biscuit & Cracker Manufacturers Association, Chocolate Manufacturers Association, Coca-Cola, Hershey’s, National Confectioners Association and many others that are FAR from suited to devise appropriate “comprehensive, long-term strategies and constructive public policies for improving the health and wellness of all Americans”

IFIC Created ‘Crisis Management’ Protocol in Case Truth Would Be Exposed

Although their names may differ, many of the functions of these groups overlap, as they’re really serving the same industry. TruthInLabeling explains how front groups such as these serve the distinct interests of the industry, not your or your children’s health, even when their well-chosen name may mislead you to think otherwise.14 Take the International Food Information Council (IFIC) for example:

“In 1990, faced with the threat of a ’60 Minutes’ segment… that might expose the toxic potential of monosodium glutamate, IFIC became actively involved in representing the interests of the glutamate industry. The IFIC represents itself as an ‘independent’ organization. It sends attractive brochures to dietitians, nutritionists, hospitals, schools, the media, and politicians, proclaiming the safety of monosodium glutamate. In 1990, an anonymous person sent us a copy of a ‘Communication Plan’ dated July-December 1991, that detailed methods for scuttling the ’60 Minutes’ segment on MSG, or, failing that, provided for crisis management.

…Depending on the roles they play, researchers might be considered agents of the glutamate industry. In addition, there are those who promote the products of those they work for, just as public relations firms do, but these organizations highlight the fact that they are nonprofit corporations, while minimizing the fact that they promote the products of those who financially support them. The International Food Information Council (IFIC) and the International Life Sciences Institute (ILSI) are examples of such glutamate-industry agents.”

50+ Industry Front Groups Form New Alliance to ‘Balance Public Dialogue’ on Food Production

As reported by Sustainable Food News15 on March 17, more than 50 of these front groups, working on behalf of food and biotechnology trade groups, have formed a brand new alliance called Alliance to Feed the Future. Again, the alliance is being coordinated by the glutamate-protecting International Food Information Council (IFIC). The stated aim of the alliance is to “balance the public dialogue on modern agriculture and large-scale food production.”

“The Alliance to Feed the Future said “in an effort to meet the world’s increasing food needs responsibly, efficiently and affordably,” its members want to ‘tell the real story of’ and dispel “misperceptions about modern food production and technology,’” the article states.16

The groups comprising the alliance represent multi-national food, biotech, and chemical companies that generate hundreds of billions of dollars-worth of revenue each year. Some of the most notable of these 50 industry groups include the very players already mentioned in this article. For the full list of all 50+ groups that are part of the alliance, please see the original article:17

American Soybean Association Biotechnology Industry Organization (which represents biotech crop giants Monsanto, DuPont, and Syngenta) Calorie Control Council (which represents the artificial sweetener industry)
Council for Biotechnology Information Grocery Manufacturers Association (GMA) International Food Additives Council (IFAC)

 

According to the featured article:18

“When asked by Sustainable Food News what misperceptions the group seeks to dispel, Dave Schmidt, CEO at the International Food Information Council, who coordinates the alliance, said the most common misperceptions – perpetuated by what he calls ‘a large popular culture’ that can be found in recent ‘books and movies’ – are that ‘technology is bad and we need to go back to a time when there was less technology. Or, food processing or large-scale food production is bad.’

…The alliance’s aim is to educate who he called ‘opinion leaders,’ including those in the university sector, professional societies, journalists and government officials. However, another target demographic is the ‘informed consumer,’ who he expects will find the group’s information online.

The Alliance’s effort appears to be an attempt to squelch the growing consumer perception that modern food production can have a negative impact on the health of humans and the environment as espoused by the organic and sustainable food movement.” [Emphasis mine]

Meanwhile, close to a dozen of the members of this new industry alliance have resigned from the Leonardo Academy’s National Sustainable Agriculture Standards Committee,19 which is currently developing a national standard for sustainable agriculture under the rules of the American National Standards Institute (ANSI). According to Russell Williams of the American Farm Bureau Federation, this exodus occurred because:

“…the committee is dominated by environmental groups, certification consultants, agro-ecology and organic farming proponents. Based on their recent actions, it is apparent that these groups have neither the vision nor desire to speak for mainstream agriculture or the 95 percent of farmers who will be materially affected by any resulting standard.”

Is the Information You’re Given Created by a Front Group Pretending to Be ‘Independent’?

As TruthInLabeling points out, the industry has manipulated public knowledge using innocent-sounding front groups for a very long time. As I’ve already shown, the International Food Additives Council (IFAC) is a perfect example of how industry giants can masquerade as a so-called non-profit, independent organization. While their membership still remains secret, the directors and officers on the IFAC board show quite plainly who’s running the show when it comes to food additives―and IFAC is obviously NOT a group of consumer advocates.

Another example can be shown through the distribution of information about MSG, which has been completely directed by the industry itself, through The Glutamate Association:

“Present FDA practice includes distributing unsolicited copies of an FDA Medical Bulletin that assures physicians that MSG is safe; and distributing similar material to food service people. In the January-February, 2003 FDA Consumer magazine, the FDA’s Michelle Meadows, in an article titled: MSG: A Common Flavor Enhancer, spewed out paragraphs that look like they came right off The Glutamate Association or the International Glutamate Information Service Web pages. Trying to convince us that MSG is ‘safe’ while saying nothing.”

The same goes for genetically engineered crops, prescription drugs, artificial sweeteners and a whole host of other harmful substances used in food production and medicine. You can bet if there’s a harmful substance out there that makes money, there are at least one or more front groups, posing as independent non-profit organizations, disseminating anything but independent safety reviews and information pertaining to it…

As for the Codex meetings, and the Group on Food Additives in particular; they’re being shrewdly manipulated by multiple front groups, which ensures that their side comes across as the strongest and most vocal. It also creates the illusion of consensus, when in fact it’s nothing but collusion… It’s high time to pull back the curtain and see who’s really pulling the strings and levers. And whenever you hear the talking points from Alliance to Feed the Future or the International Food Additives Council (IFAC), you now know exactly who is talking, and why. It’s an alliance of multi-national food-, biotech-, and chemical companies that are hell-bent on protecting hundreds of billions of dollars-worth of annual revenue in the face of a burgeoning organic and sustainable food movement. Believe what they tell you at your own risk…

Keep Fighting for Labeling of Genetically Engineered Foods

While California Prop. 37 failed to pass last November, by a very narrow margin, the fight for GMO labeling is far from over. The field-of-play has now moved to the state of Washington, where the people’s initiative 522, “The People’s Right to Know Genetically Engineered Food Act,” will require food sold in retail outlets to be labeled if it contains genetically engineered ingredients. As stated on LabelitWA.org:

“Calorie and nutritional information were not always required on food labels. But since 1990 it has been required and most consumers use this information every day. Country-of-origin labeling wasn’t required until 2002. The trans fat content of foods didn’t have to be labeled until 2006. Now, all of these labeling requirements are accepted as important for consumers. The Food and Drug Administration (FDA) also says we must know with labeling if our orange juice is from fresh oranges or frozen concentrate.

Doesn’t it make sense that genetically engineered foods containing experimental viral, bacterial, insect, plant or animal genes should be labeled, too? Genetically engineered foods do not have to be tested for safety before entering the market. No long-term human feeding studies have been done. The research we have is raising serious questions about the impact to human health and the environment.

I-522 provides the transparency people deserve. I-522 will not raise costs to consumers or food producers. It simply would add more information to food labels, which manufacturers change routinely anyway, all the time. I-522 does not impose any significant cost on our state. It does not require the state to conduct label surveillance, or to initiate or pursue enforcement. The state may choose to do so, as a policy choice, but I-522 was written to avoid raising costs to the state or consumers.”

Remember, as with CA Prop. 37, they need support of people like YOU to succeed. Prop. 37 failed with a very narrow margin simply because we didn’t have the funds to counter the massive ad campaigns created by the No on 37 camp, led by Monsanto and other major food companies. Let’s not allow Monsanto and its allies to confuse and mislead the people of Washington and Vermont as they did in California. So please, I urge you to get involved and help in any way you can, regardless of what state you live in.

  • No matter where you live in the United States, please donate money to these labeling efforts through the Organic Consumers Fund.
  • If you live in Washington State, please sign the I-522 petition. You can also volunteer to help gather signatures across the state.
  • For timely updates on issues relating to these and other labeling initiatives, please join the Organic Consumers Association on Facebook, or follow them on Twitter.
  • Talk to organic producers and stores and ask them to actively support the Washington initiative.

Source: mercola.com

What are biosimilars and are they important?

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Abstract

All prescribers will be familiar with the issues associated with the use of branded and generic ‘chemical’ medicines.1 For biological products (e.g. epoetin, filgrastim), a biosmilar medicine is a new biological product that is similar to a medicine that has already been authorised to be marketed in the EU (the biological reference medicine).2 Six biosimilar medicinal products are currently marketed in the UK—three versions of filgrastim (▼Nivestim, ▼Tevagrastim and Zarzio),3–5 two versions of epoetin (Binocrit and Retacrit)6,7 and one version of somatropin (Omnitrope).8 Applications for biosimilar versions of follitropin alfa and infliximab are under evaluation by the European Medicine’s Agency (EMA) Committee for Medicinal Products for Human Use.9 In the future there may also be biosimilar versions of insulins, recombinant vaccines, interferons and monoclonal antibodies such as rituximab and trastuzumab.10 It is estimated that about 50% of the current UK market for biological medicines by spend may be subject to biosimilar competition by 2019. In this article, we will consider the background to developing biosimilar medicines, how and why they differ from traditional generic medicines in their licensing requirements and the issues that may arise as they are introduced to clinical practice.

Source: BMJ

 

 

What place for racecadotril?

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Abstract

Worldwide, there are about two billion cases of diarrhoeal disease every year and it is the second leading cause of death in children under 5 years of age, killing 1.5 million children annually.1 The most severe threat posed by diarrhoea is dehydration. In the UK, the incidence of diarrhoea is about one episode per person per year,2 and approximately 10% of children younger than 5 years old present to healthcare services with gastroenteritis each year.3▼Racecadotril (Hidrasec) is the first in a new class of antidiarrhoeal drug (‘enkephalinase inhibitor’) that has an antisecretory mechanism and is licensed in adults, children and infants (over 3 months of age) for symptomatic treatment of acute diarrhoea or as complementary treatment when causal treatment is possible.4–6 Here we review the evidence for racecadotril and its place in the management of acute diarrhoea.

 

Source: BMJ

 

 

 

Time to say goodbye to minocycline?

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Minocycline has been licensed for over 35 years for a wide range of bacterial infections (a Summary of Product Characteristics [SPC] lists 16 indications) including respiratory, genitourinary and skin conditions.1,2 However, much of its popularity has been for its use in treating acne. Minocycline was associated with claims that it was “more effective, less likely to cause bacterial resistance and easier to take than other tetracyclines”.3 In addition, the availability of an adherence-friendly, once-daily, modified-release preparation and a lack of restriction when taken with food or ‘moderate amounts of milk’, quickly made it a favourite with general practitioners and patients. It became particularly popular for use for teenagers with acne, a group notorious for non-adherence and for whom a single daily dose was seen as an advantage. Between 1997 and 2006 about 500,000 prescriptions for minocycline were dispensed each year in England, accounting for about one third of all tetracycline prescriptions by volume and two thirds by cost.4 Partly as a result of concerns over its safety, the amount of minocycline prescribed has fallen by about two thirds, while the overall volume of prescribing of all tetracyclines has increased by 10%. However, given that over 100,000 prescriptions for minocycline are still issued each year, is further action required in light of the adverse effect profile of the drug?

Doubts about the safety of minocycline started in the 1990s with reports of rare but serious and apparently idiosyncratic adverse effects that included hypersensitivity reactions of eosinophilia, pneumonitis and nephritis, autoimmune hepatitis and lupus erythematosus-like syndrome.5,6Such reactions seem to be more common with minocycline than with other tetracyclines.7 In addition, minocycline appears to be the only tetracycline that can cause potentially irreversible slate-grey pigmentation of the skin.

Source: BMJ

 

 

Why Creating a Life-list is Important..

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If you set goals and go after them with all the determination you can muster, your gifts will take you places that will amaze you. ~Les Brown

As my debut novel, The Lake House, hit the shelves in early May, I was overwhelmed with work and found that I had little time for social activities. In an effort to reorganize for efficiency, I tracked the time I spent on tasks. To my surprise, in one day I logged over three hours just on Facebook, Twitter, Pinterest, sending emails and texts.

Now total that by seven and I’ve spent almost a full day of my week online. Multiply it by fifty-two weeks and a month and a half of my year has disappeared into the Internet. Frightening!

When you couple in workloads, household tasks, taking care of those we love, commuting, and watching our favorite television programs along with other activities it’s easy to see how a life can slip away without the focus being on our dreams becoming reality.

Most people say, “Someday I’ll ___________.” But the truth is that someday will never come when buried under the mountain of responsibility and exhaustion from overloading stimuli.

Five years ago, I made a life-list of 101 dreams I wanted to come true and I made a promise to go after my dreams with everything I had no matter how afraid I became or what roadblock I encountered. Having made this promise, I hung the list in a prominent place in my home and made it my mission to pursue as many as possible each year. I’ve now completed 90 of my biggest dreams.

The list contained four categories:

Personal life

Examples: Create an incredible group of friends who like to get the most out of life. Learn to communicate without need or expectation. Stop worrying about perfection. Fall in love with life, the world and myself.

Travel

Live in Tuscany for a month. Raft the Futaleufu River in Chile. Go to Carnival in Rio. See and photograph the slot canyons.

Career

Write a novel and get it published. (The Lake House Gallery Books/ Simon & Schuster May 7, 2013). Start my own company (Elegant Bridal Designs).

Things I Want to Learn

Learn to Salsa and Tango. Become a competitive figure skater. Learn photography.

The incredible thing about the list was that I had no idea how I was going to accomplish any of it. Most of the items felt impossible, but something miraculous happened when I placed my intention and set these goals – I began to see doorways and I refused to quit no matter what happened. Instead of spending hours watching television I went to classes. I rearranged my schedule to write. I said, ‘yes’ to opportunities. Once I made the promise, my life became focused on making my dreams come true instead of letting life happen to me.

People make lists for the grocery store. They write down household repairs and upgrades, yet many don’t make a plan for their lives. In this world of technology it’s too easy to lose your time in a virtual world instead of getting out and exploring this incredible playground we call life.

So how do you start? Sit down with a pen and paper and think about everything you’ve ever wanted to do. Dream bigger than you can see yourself being. Realize if you’re afraid then you’re on the right track. Fear tells you that you want it so badly it would hurt not to accomplish it.

Now I have to get off of my computer because the time I’ve allotted for work is up. Next on the list is to learn how to play on silks at an acrobatic school.

Source: Purpose Fairy

Management of infantile colic.

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Abstract

Although infantile colic is considered to be a self-limiting and benign condition, it is often a frustrating problem for parents and caregivers. It is a frequent source of consultation with healthcare professionals and is associated with high levels of parental stress and anxiety.1,2Several published reviews of the literature have explored dietary, pharmacological, complementary and behavioural therapies as options for the management of infantile colic.1,3 Here, we assess whether these management options are supported by the literature and if there are any novel treatment options.

About infantile colic

Infantile colic has been defined as paroxysmal uncontrollable crying in an otherwise healthy infant less than 3 months of age, with more than 3 hours of crying per day, in more than 3 days a week and for more than 3 weeks.4,5 It is known to have a significant impact on infants and their families, with up to one in six families with children with symptoms of colic consulting healthcare professionals.6

Background

Despite the prevalence of the condition, the pathogenesis remains incompletely understood. One hypothesis has suggested that infantile colic is caused by the impact of abnormal gastrointestinal motility and pain signals from sensitised pathways in the gut viscera.2 Another hypothesis is that inadequate amounts of lactobacilli and increased amounts of coliform bacteria in the intestinal microbiota influences gut motor function and gas production, which subsequently contributes to the condition.2

More controversially, behavioural issues such as family tension, parental anxiety or inadequate parent-infant interaction have also been explored as causative factors for infantile colic.1 In addition, little is known about concomitant risk factors; however, maternal smoking, increased maternal age and firstborn status are thought to be associated with the development of infantile colic. No association with feeding method has been noted.1

As a consequence of the lack of understanding of the cause of the condition, a wide spectrum of treatment modalities have been suggested, with each one targeted to address a postulated cause.

Diagnosis

Although infantile colic is by definition a benign condition, healthcare professionals should address parental concerns carefully, as the diagnosis is made by exclusion of more sinister causes.

Management options

There are numerous issues with the methodological rigour of many intervention studies with several systematic reviews on infantile colic describing shortcomings in trial methodology. Whilst some form of randomisation was performed with many of these studies, lack of a clear definition for infantile colic, absence of clinically meaningful  end-points (aside from crying duration), and limited detail on sample size calculations, allocation concealment and randomisation methods are likely to have affected the validity of the results. It is therefore appropriate to take a cautious approach in translating the outcomes of research to practical recommendations for managing infantile colic.

Diet modification

Based on the theory that infantile colic results from excessive gas production from poor gut digestion of cow’s milk proteins, several nutritional interventions have been reviewed.2

In practice, any positive impact of diet modification may result from improving symptoms of colic secondary to a previously undiagnosed cow’s milk protein allergy in the infant. Therefore, it is important that cow’s milk protein allergy is considered during the assessment of an infant with inconsolable crying. There are currently no reported unwanted effects for any of the diet modification studies described below.9

Hypoallergenic formula preparations for bottle-fed infants

In hydrolysed formulae, whole milk proteins are broken down to prepare them for digestion. These can range from partially hydrolysed to completely hydrolysed formula preparations with the former often used for lactose intolerance and the latter used in the management of cow’s milk protein allergy.9

Several systematic reviews have identified studies that demonstrated that completely hydrolysed formulae significantly improved clinical symptoms of infantile colic, such as crying time.1,9,10 These studies used standard cow’s milk formula as the comparator and improvements were noted from 7 days onwards. When carbohydrate and fat content compositions were varied in one study, both proved similarly effective in reducing colic symptoms, suggesting that changes to carbohydrate and fat content had no effect.9

In one systematic review, two randomised controlled trials (RCTs) noted that partially hydrolysed formulae reduced colic symptoms after 14 days of feeding. However, the trials did not involve a direct comparison with a regular cow’s milk formula, but compared partially hydrolysed formulae and soy-based formulae.9

Where a suspicion of cow’s milk protein allergy exists there is some evidence that the use of an empirical time limited trial of a completely hydrolysed formula is a reasonable option.1,9,10Correspondingly, whilst there is some literature advocating the use of partially hydrolysed formula,9 its use for the dietary management of colic would not be recommended because partially hydrolysed formulae are not hypoallergenic and therefore will not address colic symptoms secondary to a protein allergy.10

High-fibre formula

High fibre or fibre-enriched formulas are those that are fortified with typically a soy polysaccharide to increase the dietary fibre concentration. An RCT identified by two systematic reviews found no significant difference in symptoms when comparing a high-fibre formula with a standard formula.1,9

Soy-based formula

Two systematic reviews noted several low quality studies that demonstrated a reduction in crying duration when comparing soy-based formula with standard cow’s milk formula after 7 days of feeding.9,10 However, due to concerns about the levels of phytoestrogens in soy-based formula and that soy protein may be an allergen in infancy, its use in infantile colic is not recommended.10,11

Hypoallergenic maternal diet for breast-fed infants

A hypoallergenic diet for breast feeding mothers excludes cow’s milk products and other possible trigger foods. In comparison to the use of a hypoallergenic infant formula, there is limited evidence supporting the use of hypoallergenic maternal diet, with several studies noting equivocal results.1,9,10 This has been attributed to the use of an incompletely hydrolysed diet without a thorough exclusion of trigger foods that could have reduced the effect of the intervention.9

One systematic review, identified a good quality RCT in which mothers eliminated dairy foods, eggs, peanuts, tree nuts, wheat, soy and fish from their diet.9 The primary endpoint of the study was a reduction in cry/fuss duration of >25% from baseline with more responders in the low-allergen diet group compared with the control group, 74% vs. 37%, an absolute risk reduction of 37% (95%CI 18% to 56%).10 Two earlier studies reported similar findings but neither separated the results for breastfed infants from hypoallergenic formula fed infants.9

On balance there is limited evidence to suggest that hypoallergenic diets in mothers may be helpful. If a time limited trial is undertaken, mothers should be advised to exclude trigger foods including cow’s milk products from their diet and to ensure that they and their infant receive appropriate nutritional support, including calcium and vitamin D intake. They should also be advised not to discontinue breastfeeding while switching to the hypoallergenic maternal diet.1,9,10

Lactase therapy

In lactase therapy, galactosidase (lactase) drops are mixed with breast or bottle milk feeds up to 24 hours prior to feeding the infant. A systematic review identified two RCTs where an improvement in symptoms was noted with the use of lactase therapy. In one RCT, a relative decrease in crying time of 22.4% (95% CI 13% to 44%) was noted.1 This conflicted with several other RCTs noting no improvement with the use of lactase in either breast or formula milk. In one example, only a 40-minute reduction in crying time was observed compared with placebo.1

Pharmacological management

It is hypothesised that the gut’s peristaltic cholinergic activity is linked to gastrointestinal discomfort in infantile colic. Consequently, anticholinergics, such as dicyclomine hydrochloride and cimetopium bromide, which reduce smooth muscle activity, have been studied. Neither of these drugs are licensed in the UK for use in infants.

In one systematic review, two studies investigating dicyclomine hydrochloride noted improvement in colic symptoms. However, severe adverse effects including respiratory distress and seizures led to its licence withdrawal in infants less than 6 months of age.7 One study has reported significant improvements with the use of cimetropium bromide with only drowsiness noted as a side effect.1,3–7

Simethicone (Infacol®), which reduces intraluminal gas and is readily available over the counter, has been studied in two RCTs. No difference in reducing colic episodes was shown compared with placebo.1,7

Complementary therapies and other interventions

In the absence of safe and effective pharmacological interventions, complementary therapies have taken a more prominent role in the management of infantile colic. These can range from conventional therapies, such as dietary supplements, sugar solutions, herbal extracts or massage, to controversial options such as chiropractic treatment.

Herbal supplements

A systematic review identified several studies of herbal supplements, such as fennel extract and mixed herbal tea that showed a reduction in symptoms of infantile colic.12 However, several adverse effects such as vomiting, sleepiness, constipation and loss of appetite were also noted.12 Minimal information on extraction and preparation of herbs and lack of standardisation of dosage and formulations have also limited their use.2

Sucrose solutions

Two studies compared glucose solutions with placebo and found positive effects in relieving symptoms.2 However, there are concerns about potential nutritional effects, in particular the content of sugar and alcohol, the lack of formulation standardisation and the poor quality of the evidence.2,12,13

Probiotics

Based on the hypothesis that aberrant intestinal microflora affecting gut function and gas production may contribute to the condition, the use of probiotics in infantile colic has become more common. Numerous studies have been identified in a systematic review.12,14,15 One randomised double blind placebo controlled trial involving 46 infants used a suspension of freeze-dried Lactobacillus reuteri. There were significantly more responders (50% reduction in crying time from baseline) in the L reuteri group on days 7 (20 vs. 8; p = 0.006), 14 (24 vs. 13; p = 0.007), and 21 (24 vs. 15; p = 0.036). A further RCT identified good weight gain and gastrointestinal tolerance.2

Massage

One study noted a positive effect in massage utilising aromatherapy oils. However, the results were not separated between massage and aromatherapy.16 Whilst several other studies identified in a systematic review12,13 showed some improvement on symptoms of colic, overall the quality of these studies is poor.

Swaddling

Swaddling has traditionally been used by some parents to reduce crying in infancy. A systematic review noted that swaddling reduced crying symptoms compared with massage in excessively crying infants with cerebral damage.17 However, there is a known associated risk of developing hip dysplasia, overheating or sudden infant death syndrome if placed in the prone position. The current evidence base, therefore, does not support the use of swaddling in the management of infantile colic.

Chiropractic treatment

As a more controversial complementary therapy, chiropractic care is sometimes advocated as a treatment option for infantile colic. Chiropractic care can include, but is not limited to, cranial osteopathy and spinal manipulation therapy. The evaluation of treatment options in this field is challenging due to the absence of good quality RCTs. Additionally, adverse effects such as vertebral artery dissection have been reported anecdotally.18,19

It is hypothesised that chiropractic care can have a positive effect on symptoms; however, the literature has noted that this may be a consequence of improving parents’ coping ability with the condition rather than true effectiveness of chiropractic care.20

In several systematic reviews, one single blinded RCT was identified noting no differences in outcomes between chiropractic care and placebo, which was infant holding by a nurse.21Several other studies were identified noting positive treatment effects; however, these were noted to be of low quality.12,18,19,21,22

Acupuncture

Several RCTs evaluating acupuncture were identified, of which two RCTs noted a shorter duration and intensity of infantile colic symptoms.23,24 Another good quality double blinded RCT comparing acupuncture with a sham needle insertion noted no major effect on symptoms including feeding, bowel movement frequency and sleep.25

Behaviour modification

Several behavioural interventions were identified, that aimed to provide reassurance to parents and offer alternative methods to treat colic.3

One systematic review identified two controlled trials where the use of modified parent and infant interaction led to significant reduction in colic symptoms and additional benefits of early gains in development.1,26 This has been attributed to increased maternal responsiveness and time spent with infants resulting in increased infant alertness. In another study, entire family involvement utilising an integrated care model led to the relief of infantile colic symptoms more readily than standard care.27 The use of ‘contingent music’ was noted to decrease symptoms in another study.1

It has been noted that the identification of effective coping strategies and counselling methods to assist parents in managing this stressful condition is imperative.28 A systematic review identified two studies addressing this; one study utilised a home based nursing intervention and another utilised counselling on specific management techniques and car ride simulation in infants over 6 weeks of age, leading to significant reductions in parental stress and anxiety.1,3

Guidelines

The National Institute for Health and Clinical Excellence guideline on postnatal care advises that holding the baby through the crying episode, and accessing peer support may be helpful, and that the use of hypoallergenic formula in bottle-fed babies should be considered for treating colic, but only under medical guidance.29

A position statement by the Canadian Paediatric Society on dietary interventions commented that a minority of infants have symptoms of infantile colic secondary to cow’s milk protein allergy, and in such cases a maternal hypoallergenic diet for breastfed infants and an extensively hydrolysed formula for bottle fed infants may help.10 In addition, it concluded that there is no proven role for the use of soy-based formulas or lactase therapy and insufficient data to make a recommendation on the effect of probiotics.

The Clinical Knowledge Summary (CKS) noted that “although there are many studies of interventions for infantile colic, most are of poor methodological quality”.30 The guidance suggests that clinicians should “only consider trying medical treatments if parents feel unable to cope despite advice and reassurance”. Options listed include a 1-week trial of simeticone drops (breastfed or bottle-fed infants); a 1-week trial of diet modification to exclude cow’s milk protein (dairy-free diet for the mother [breast-fed infants], hypoallergenic formula [bottle-fed infants]); a 1-week trial of lactase drops (breastfed or bottle-fed infants). However, it should be noted that the CKS guidance was last revised in 2007. A Map of Medicine healthguide on infantile colic also cites the CKS guidance.31

Other issues

There is evidence of inconsistent advice relating to early infant crying and colic in various media outlets such as parenting magazines.32 Advice was noted to be “diffuse, varied, and generally unrelated to the current evidence-based conceptualization of early infant crying”.

Advice for community pharmacists has summarised many of the options available over the counter (including those for which there is little evidence of efficacy e.g. gripe water) and highlighted resources and support groups.33

Conclusion

Parents with infants with colic commonly consult a healthcare professional. Each case should be thoroughly assessed because of the wide range of other conditions that can present in a similar way. For the majority of cases simple reassurance is all that is required. If the clinician feels intervention is required, there are a wide range of options available with a poor evidence base to support any of them.

Currently, there are no effective and safe pharmacological management options available over the counter or by prescription. Simeticone, lactase drops and probiotics are unlikely to be harmful, but there is little evidence to support their use. Whilst complementary treatment options exist there is currently insufficient evidence to recommend their use. The absence of strong evidence is similarly noted for behavioural modification interventions. Despite this, the absence of side effects makes the argument for a trial of such an intervention more compelling.

Where there is a suspicion of cow’s milk protein allergy, a short trial of hypoallergenic feeding, through a hypoallergenic formula in bottle-fed infants may be considered. The improvement in infants with this approach may in part be as a result of treatment of undiagnosed cow’s milk allergy rather than symptomatic improvement of colic. In breastfeeding mothers there is limited evidence that a fully hypoallergenic exclusion diet may be helpful if undertaken carefully.

Infantile colic, whilst self-limiting and benign, can cause considerable distress to parents and it is therefore important that parental support is provided. Advice and guidance on where to obtain support outside conventional healthcare sources should be discussed with parents.

Source: BJM

How to Follow Your Passion when People Doubt You.

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DREAMZS

And the day came when the risk to remain tight in a bud was more painful than the risk it took to blossom. ~Anaïs Ni

I’ve been so incredibly lucky recently. I’ve (finally!) discovered my absolute passion, the thing that makes me sprint home from work, makes me jump out of bed in the morning (I know!) and gives me natural energy. Writing and reading about all things inspirational and communicating with my readers is what keeps me going.

If you’ve been reading Purpose Fairy for a while, you’re probably in this category as well.  If you’re anything like me, you probably have people in your life who respond to this is various ways:

People who think you’re a bit weird and just leave you alone.

People who are curious, but don’t want to ask about it in case someone else finds out.

People who ask and then have huge ‘a-ha’ moment as you speak.

People who are crazy interested and completely on the same wavelength.

People who think you’re just going through a bit of a phase and roll and their eyes at you.

People who laugh at it and joke that you’ll end up in a hippy commune before you can say ‘incense’.

However, for years, I was unwilling to tell anyone know that I was interested in self-improvement and spiritually. I even managed to fool myself for a while and pushed it away for as long as possible. I didn’t want to look like I had my head in the clouds and definitely didn’t want to explain any of my reasons for dive-bombing into my passion and going full-steam ahead with it.

Would everyone say ‘I told you’ so if it failed? What if they spoke about me behind my back? What if they criticized me?

I’ve learned over time that the universe will bring people and events into your path for a reason. It’s so easy though when you’re totally ‘in the zone’, to ignore all these comments and fire on through because you want it so badly. But often the universe guides you through the messages of those close to you.

There will be times when you will encounter resistance from those around you, there will be moments when nobody will believe in you and your dreams but if

Your time is limited, so don’t waste it living someone else’s life. Don’t be trapped by dogma – which is living with the results of other people’s thinking. Don’t let the noise of other’s opinions drown out your own inner voice. And most important, have the courage to follow your heart and intuition. They somehow already know what you truly want to become. Everything else is secondary. ~Steve Jobs

If someone chooses to ask about your interests, see this as a gift- they are giving their time and are genuinely interested in your life. Don’t presume they just being nice- you’ve obviously sparked something in them.

Hear their answers as much as you’d like them to hear yours- they might have some golden wisdom of their own, and they might even be able to help you or connect you with someone.

Listen to their concerns- they’re not always doing it to discourage you. Do you really need to spend thousands of dollars on that course when you could just start today? Are you procrastinating out of fear? Sometimes people see things that we don’t when we’re in our heads, and it’s these things that can real turn projects and ideas into game-changers.

Meditate on your passion and be sure it’s what you really what in your heart of hearts- are you doing it for you, or for someone else? Is this what you really want or are you doing it to prove a point to someone, or to yourself?

If people seem to be laughing at you, laugh with them- don’t take it so personally. All my friends know I’m vegan, a metaphysical book freak and I love wearing 80′s clothing, and I’m fine with that (more importantly, I realized, so are they). Passionate should be joyous, liberating and harmonious, not serious, rigid and stifling.

Listen to others and thank them for their words. Sometimes, people have a funny way of showing it (cue family!), but they always have your best interests at heart. But just think, are they reallyholding you back or are you using them as an excuse not to blossom?

 

Source: purpose fairy

 

9 Dodgy Food Practices Banned in Europe but Just Fine Here.

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pig-feedcow-feed 

Story at-a-glance

  • Thanks to a largely industry-beholden government and regulatory system, Americans are not being afforded many of the same food protections given to Europeans
  • Examples of chemicals and drugs allowed in US foods and agriculture but banned in Europe include the endocrine-disrupting weed killer Atrazine, arsenic in chicken feed, antibiotics as agricultural growth promoters and chlorine washes for poultry carcasses
  • The US also embraces water fluoridation and genetically modified (GM) foods, two practices that are much less accepted, and in some cases banned, in Europe
  • If you want to avoid these questionable ingredients, additives and unethical practice and you live in the US, ditching processed foods entirely is the best option
  • The US Department of Agriculture (USDA) is rolling out new rules that would permit poultry producers to put all the poultry through an antimicrobial wash, using chlorine and other chemicals to kill pathogens. We already have a problem with antibiotics causing antibiotic-resistant “super germs” when used in animal feed, and this could likely make the problem even worse.

    Workers in the plants have also reported health problems from the chemical washes, including asthma and other respiratory problems. In the European Union, the use of chlorine washes is not only banned, but they won’t even accept US poultry that’s been treated with these antimicrobial sprays.

  • Many Americans believe the US is at the forefront of technology and advancements to protect its citizens’ health. But, time and again we’re seeing that Americans are actually less healthy than their peers overseas.
  • In fact, despite spending twice the amount per capita on health care, the US recently ranked last in a health and mortality analysis of 17 developed nations.1
  • In many cases, adhering to government-sponsored health and dietary guidance has led Americans astray but so, too, has exposure to harmful substances and practices that continue to receive the “green light” in the US while being banned in Europe.
  • Thanks to a largely industry-beholden government and regulatory system, Americans are simply not being afforded the same protections given to Europeans.
  • Mother Jones recently highlighted seven dodgy practices banned in Europe but allowed in the US,2 and I added in a couple of my own. In terms of looking out for your safety, this list gives an eye-opening perspective on where US regulatory agencies’ true interests lie.
  • 1. Atrazine
  • Banned in Europe in 2003, Syngenta‘s weed killer Atrazine is a potent endocrine disruptor that, according to UC Berkeley Professor Tyrone Hayes, “chemically castrates and feminizes wildlife and reduces immune function in both wildlife and laboratory rodents.” The chemical has also been found to induce breast and prostate cancer, retard mammary development and induce spontaneous abortion in lab animals, with studies in humans suggesting similar risks.
  • In the US, Atrazine is widely used and has become a common drinking water contaminant. Syngenta already had to pay $105 million to settle a class-action lawsuit in which water utilities in the Midwest claimed Atrazine had contaminated their drinking water.3
  • Atrazine has been banned in the European Union—including Switzerland, where it’s manufactured—as well as several Wisconsin counties in the US. However, the US Environmental Protection Agency (EPA) still allows its use and is only going to begin conducting a registration review, “EPA’s periodic reevaluation program for existing pesticides,” in mid-2013.4
  • 2. Arsenic in Chicken, Turkey and Pig Feed
  • Arsenic-based drugs are approved for use in animal feed in the US because they make animals grow quicker and make the meat appear pinker (i.e. “fresher”). The US Food and Drug Administration (FDA) has stated these products are safe because they contain organic arsenic, which is less toxic than the other inorganic form, which is a known carcinogen.
  • The problem is, scientific reports surfaced stating that the organic arsenic could transform into inorganic arsenic, which has been found in elevated levels in supermarket chickens. The inorganic arsenic also contaminates manure where it can eventually migrate into drinking water and may also be causing heightened arsenic levels in US rice.
  • In 2011, Pfizer announced it would voluntarily stop marketing its arsenic-based feed additive Roxarsone, but there are still several others on the market. Several environmental groups have filed a lawsuit against the FDA calling for their removal from the market. In the European Union, meanwhile, arsenic-based compounds have never been approved as safe for animal feed.
  • 3. Poultry Litter in Cow Feed
  • Chicken litter, a rendered down mix of chicken manure, dead chickens, feathers and spilled feed, is marketed as a cheap feed product for cows. The beef industry likes it because it’s cheaper than even corn and soy, so an estimated 2 BILLION pounds are purchased each year in the US.
  • However, any cow that eats chicken litter may also be consuming various beef products intended for chickens – raising concerns about Mad Cow Disease. And it’s not only the spilled feed that’s the problem; the infectious agent can also be passed through the chicken manure as well. In the US, the use of poultry litter in cow feed is unrestricted. Europe banned all forms of animal protein, including chicken litter, in cow feed in 2001.
  • 4. Chlorine Washes for Poultry Carcasses
  • The US Department of Agriculture (USDA) is rolling out new rules that would permit poultry producers to put all the poultry through an antimicrobial wash, using chlorine and other chemicals to kill pathogens. We already have a problem with antibiotics causing antibiotic-resistant ”super germs” when used in the animals’ feed, and this could likely make the problem even worse.
  • Workers in the plants have also reported health problems from the chemical washes, including asthma and other respiratory problems. In the European Union, the use of chlorine washes is not only banned, but they won’t even accept US poultry that’s been treated with these antimicrobial sprays.
  • 5. Antibiotics as Growth Promoters on Livestock Farms
  • Agricultural uses account for about 80 percent of all antibiotic use in the US, so it’s a MAJOR source of human antibiotic consumption. Animals are often fed antibiotics at low doses for disease prevention and growth promotion, and those antibiotics are transferred to you via meat, and even via the manure used as crop fertilizer. Feeding livestock continuous, low-dose antibiotics creates a perfect storm for widespread disease proliferation — and, worse yet, antibiotic-resistant disease.
  • The FDA has long held — since 1977 in fact — that administering low doses of antibiotics to livestock, as is common among Confined Animal Feeding Operations (CAFOs), was inappropriate, yet they continue to pander to the drug industry and are allowing the practice to continue.
  • The FDA says it will focus its efforts on voluntary reform in the realm of antimicrobial use, which means the industry would have to decide to stop using low-dose antibiotics in animal feed on their own — a measure they have been vehemently opposed to because the antibiotics make the animals grow faster, which increases their profit margins. In Europe, all antibiotics used in human medicine are banned in agriculture, and no antibiotics can be used for growth-promoting purposes.
  • 6. Ractopomine and Other Pharmaceutical Growth Enhancers in Animal Feed
  • Ractopamine is banned in 160 countries, including Europe, Taiwan and China. If imported meat is found to contain traces of the drug, it is turned away, while fines and imprisonment result for its use in banned countries. Yet, in the United States an estimated 60-80 percent of pigs, 30 percent of ration-fed cattle, and an unknown percentage of turkeys are pumped full of this drug in the days leading up to slaughter because it increases protein synthesis.
  • In other words, it makes animals more muscular … and this increases food growers’ bottom line. Adding insult to injury, up to 20 percent of ractopamine remains in the meat you buy from the supermarket, and this drug is also known to cause serious disability, including trembling, broken limbs and an inability to walk, in animals.
  • It’s also killed more pigs than any other animal drug on the market. While Europe has remained steadfast on its Ractopamine ban, including refusing imported meat treated with it, the US is actively trying to get other nations to change their minds and accept Ractopamine-treated pork.
  • 7. Gestation Crates
  • Gestation crates are two-foot-wide cages where breeding pigs spend nearly their entire lives, unable to even turn around. Commonly used on CAFOs, the crates are the definition of inhumane and cause severe stress to the animals, who in some cases will resort to chewing the bars of the cages incessantly, causing them become covered in blood.
  • While several US pork producers, including Smithfield, Cargill and Hormel, have pledged to phase the crates out, and fast-food chains including McDonald’s, Burger King, Wendy’s and Subway have promised to stop buying from pork producers who use them, the practice remains widespread in the US. Europe, however, banned gestation crates entirely, effective this year.
  • 8. Water Fluoridation
  • Many do not realize that fluoride is a drug that is available only with a prescription. Yet it’s added to municipal water supplies used by more than 180 million Americans, including infants and the elderly without any attention to personalized dosing or potential interactions.
  • Swallowing fluoride has been shown to cause weakened bones, bone cancer, hyperactivity and/or lethargy, lowered thyroid function, lowered IQ, dementia, kidney issue, arthritis and more, while studies have failed to show benefits for preventing cavities when taken internally. Cities around the US spend millions adding fluoride to communal water supplies each year, yet most European countries do not fluoridate their water.
  • 9. Genetically Modified (GM) Foods
  • The European Union has historically taken a strict, cautious stance regarding GM crops, much to the chagrin of biotech giant Monsanto and in stark contract to the US. For instance, while GM crops are banned in several European countries, and all genetically modified foods and ingredients have to be labeled, the US has recently begun passing legislation thatprotects the use of GM seeds and allows for unabated expansion, in addition to the fact that GM ingredients do not have to be labeled.
  • Virtually all of the claims of benefit of GM crops – increased yields, more food production, controlled pests and weeds, reductions in chemical use in agriculture, drought-tolerant seeds — have not materialized while evidence pointing to theirserious risks for human health and the environment continues to grow.
  • The list above is only a partial one. There are, unfortunately, many other examples where the US has sold out to industry at the expense of its citizens’ health, while other countries have chosen to take a much more precautionary or ethical stance. For instance, food additives banned in other countries yet allowed in the US include various food dyes, the fat substitute Olestra, brominated vegetable oil, potassium bromate (aka brominanted flour), Azodicarbonamide, BHA, BHT, rBGH and rBST. Europe has also recently banned animal testing for cosmetics and personal hygiene products, a practice that is still allowed in the US.
  • If you want to avoid these questionable ingredients, additives and unethical practices and you live in the US, ditching processed foods entirely is the best option. If you live in Europe you may have more options than Americans, as you may be able to find some processed foods that do not contain any synthetic additives (although non-processed is still highly preferable). About 90 percent of the money Americans spend on food is spent on processed foods, so there is massive room for improvement in this area for most people.
  • Swapping your processed-food diet for one that focuses on fresh whole foods is a necessity if you value your health. For a step-by-step guide to make this a reality in your own life, whether you live in the US or elsewhere, simply follow the advice in myoptimized nutrition plan, starting with the beginner plan first.

·         9 Dangerous Practices Banned in Europe but Allowed in the US

·         Do You Want REAL Food for Your Family?

Source: mercola.com

Panitumumab Fails to Improve Outcome in Esophagogastric Cancer.

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Adding panitumumab to chemotherapy resulted in significantly shorter overall survival.

 

For patients with adenocarcinomas of the esophagus and stomach, conventional 5-fluorouracil (5-FU) plus platinum-based chemotherapy achieves an overall survival of only 9 to 11 months. The only targeted therapy approved for this disease is trastuzumab, which improves response and survival when combined with chemotherapy in human epidermal growth factor receptor 2 (HER2)-positive metastatic disease (JW Oncol Hematol Sep 14 2010).

Investigators from the U.K. now report the results of an industry-funded, open-label, multicenter, randomized, phase III trial of the epidermal growth factor receptor (EGFR)-targeted agent panitumumab plus chemotherapy for untreated metastatic esophagogastric cancer. Patients received either EOC: epirubicin (50 mg/m2), oxaliplatin (130 mg/m2), and capecitabine (1250 mg/m2/day for 21 days) cycled every 3 weeks; or modified EOC plus panitumumab: epirubicin (50 mg/m2), oxaliplatin (100 mg/m2), and capecitabine (1000 mg/m2/day for 21 days) plus panitumumab (9 mg/kg) cycled every 3 weeks.

Of 1000 planned patients, only 553 were treated due to early trial closure after an interim analysis showed inferior overall survival with modified EOC plus panitumumab. Most patients treated were male (82%–83%), were age 60 or older (60%–62%), and had performance status 1 (52%) and cancers of the esophagus (38%–40%) or gastroesophageal junction (27%–34%).

Although rates of response were equivalent in the two treatment arms (42%–46%), modified EOC plus panitumumab resulted in inferior overall survival (the primary endpoint; 8.8 vs. 11.3 months; HR 1.37; P=0.013) and a trend toward inferior progression-free survival (6.0 vs. 7.4 months; HR 1.22; P=0.068). Modified EOC plus panitumumab resulted in more grade 3 or 4 diarrhea, mucositis, and skin rash, but less grade 3 or 4 neuropathy and hematologic toxicity, likely due to a shorter duration of therapy.

Comment: This large, randomized trial in unselected patients with advanced esophagogastric cancer indicates that the addition of panitumumab to chemotherapy has a deleterious effect on patient outcomes. These findings are consistent with those simultaneously reported for cetuximab (JW Oncol Hematol May 28 2013).Given these strikingly negative results, interest in further study of potential EGFR-targeted therapies for esophagogastric cancer will likely diminish, and the possibility of discovering a biomarker to identify patients who might benefit from such treatments is unlikely.

 

Source: Journal Watch Oncology and Hematology

 

 

 

Selective Amygdalohippocampectomy vs. Anterior Temporal Lobectomy for Epilepsy

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In a meta-analysis of nonrandomized studies, seizure-free outcome was greater after ATL than after SAH.

 

In the surgical treatment of intractable medial temporal lobe epilepsy (MTLE), an important unanswered question is whether seizure-free outcome is better with standard anterior temporal lobe resection (ATL) or with a more restrictive procedure, selective amygdalohippocampectomy (SAH). In theory, SAH might mitigate some neuropsychological deficits that are associated with ATL. However, seizure freedom also has important psychosocial benefits. To examine this question, researchers conducted an exhaustive systematic review and meta-analysis of published studies on seizure outcomes following either ATL or SAH. They identified 13 studies that compared the two procedures. Nearly all studies were from individual centers, and follow-up was carried out by clinic visits or telephone calls by investigators or unspecified individuals. Duration of outcome measures ranged from 1 year to a median of 10.9 years. Only three studies separated follow-up according to procedure type; in two, follow-up was an average of 14 to 26 months longer for ATL; in the third, follow-up was an average of 2 months longer for SAH. Other differences in study populations were not specified.

From 11 studies that provided dichotomous outcomes (Engel class I vs. Engel class II–IV), 583 participants had SAH and 620 had ATL. Seizure-free outcome was significantly greater with ATL at final follow-up (relative risk, 1.32; risk difference, 8%; number needed to treat, 13). Results were similar with a more conservative random effects model, in the subset of studies with standardized outcome duration, and among patients with only hippocampal sclerosis. Cumulative addition of studies to the meta-analysis demonstrated a stable RR estimate starting before the most recent three studies were added. Five studies providing data on surgical complications in 392 after ATL and 309 after SAH showed no significant difference.

Comment: This thorough meta-analysis exploited a sufficiently large number of cases, roughly balanced between anterior temporal lobe resection and selective amygdalohippocampectomy (SAH), to provide meaningful information regarding the difference in seizure-free outcomes. This study is particularly valuable because a randomized, controlled trial (RCT) — which the authors say is “justified” — is unlikely to be funded. And yet, an RCT is a compelling proposal if only to address the need for balance in each treatment arm of known variables that affect seizure outcome. Further, only an RCT can answer whether the central postulated benefit of SAH — reduced neuropsychological deficits — exists.

 

Source: Journal Watch Neurology