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Entries in FDA (55)

Tuesday
Sep112012

Jason Mark -- Whoa, Is Organic Food No Healthier Than Non-Organic? Controversy Erupts Over Study

I had barely drank my first cup of coffee when I heard the news yesterday morning on NPR [3] – organic food, it turns out, may not be that much healthier for you than industrial food.

The NPR story was based on a new study published in the Annals of Internal Medicine [4] which concluded, based on a review of existing studies, that there is no “strong evidence that organic foods are significantly more nutritious than conventional foods.” The study, written by researchers at the Stanford School of Medicine, also found that eating organic foods “may reduce exposure to pesticide residues and antibiotic-resistant bacteria.”

The interwebs were soon full of headlines talking down the benefits of organic foods. “Stanford Scientists Cast Doubt on Advantages of Organic Meat and Produce,” the NY Times [5] announced, as reporter Kenneth Chang pointed out that pesticide residues on industrially grown fruits and vegetables are “almost always under the allowed safety limits.”CBS news [6], running the AP story on the Stanford study, informed readers: “Organic food hardly healthier, study suggests.”

Organic agriculture advocates were quick with their rebuttals. The Environmental Working Group [7] put out a press release playing up the researchers’ findings that organic produce has less pesticide residue. Charles Benbrook, a professor of agriculture at Washington State University and former chief scientist at The Organic Center [8], wrote a detailed critique you can find here [9]. Benbrook noted that the Stanford study didn’t include data from the USDA and US EPA about pesticide residue levels. He also pointed out that the researchers’ definition of “significantly more nutritious” was a little squishy.

Is this the last word on the nutritional benefits of organic foods? Hardly. As Benbrook said, in the coming years improved measurement methods will hopefully allow for better comparisons of food nutritional quality. (You can find an Earth Island Journal cover story on this very issue here [10].)

I’ll leave it to the PhDs and MDs to fight this out among themselves. As they do, I’ll keep buying (and growing [11]) organic foods. Why? Because even if organic foods are not demonstrably better for my health than industrial foods, I know that organics are better for the health of other people – the people who grow our nation’s food.

To his credit, NPR’s new ag reporter, Dan Charles, was careful to note that organic agriculture “can bring environmental benefit[s].” One of the most important environmental benefits organic agriculture delivers is a boost to public health and safety.

Let’s say you’re not worried about the relatively small amounts of pesticides that end up on the industrial foods at the supermarket. (Though you should read this [12] Tom Philpott dissection of the Stanford report when considering your risk of eating pesticide residue.) Well, you should still be concerned about the huge amounts of pesticides that end up in the air and water of farming communities – chemicals that can lead to birth defects, endocrine disruption, and neurological and respiratory problems.

When pesticides are sprayed onto farm fields, they don’t just stay in that one place. They seep into the water and waft through the air and accumulate on the shoes and clothes of farm workers. In recent years in California (the country’s top ag producer) an average of 37 pesticide drift incidents [13] a year have made people sick. Pesticides also find their way into the homes of farm workers. A study by researchers at the University of Washington found that the children of farm workers have higher exposure to pesticides [14] than other children in the same community. When researchers in Mexico looked into pesticide exposure of farm workers there, they found that 20 percent of field hands “showed acute poisoning. [15]

The health impacts on those workers were serious and included “diverse alterations of the digestive, neurological, respiratory, circulatory, dermatological, renal, and reproductive system.” The researchers concluded: “there exist health hazards for those farm workers exposed to pesticides, at organic and cellular levels.”

There are shelves’ worth of studies [16] documenting the health dangers of pesticide exposure. A study published last year found that prenatal exposure to organophosphate pesticides [17] – which are often sprayed on crops and in urban areas to control insects – can lower children’s IQ. A follow-up investigation into prenatal pesticide exposure concluded that boys’ developing brains appear to be more vulnerable [18] than girls’ brains. A study by Colorado State University epidemiologist Lori Cragin found that women who drink water containing low levels of the herbicide atrazine are more likely to have low estrogen levels [19] and irregular menstrual cycles; about three-quarters of all US corn fields are treated with atrazine annually. British scientists who examined the health effects of fungicides sprayed on fruits and vegetable crops discovered that 30 out of 37 chemicals studied altered males’ hormone production [20].

Read more.. http://www.alternet.org/food/whoa-organic-food-no-healthier-non-organic-controversy-erupts-over-study

Wednesday
Aug222012

Paula Alvarado -- A landmark ruling against agrochemicals in Argentina receives mixed reactions 

Argentine activist Sofia Gatica did not win the Goldman Environmental Prize this year for a small reason: for more than a decade, she has been leading a joint complaint with neighbors from her town Ituzaingo, in Cordoba province, against producers who were spraying agrochemicals too close to the community, making people sick. (The public attorney claimed 169 people from the 5,000 neighbors got cancer from pollution from 2002 until 2010.)

Argentina being the third largest exporter of soybeans and a consumer of over 50 million gallons of glyphosate and endosulfan, her efforts were not small. In fact, she became the voice for a problem nobody wants to talk about.

Since the government depends on soy exports to collect taxes and keep the economy alive, the subject is not one eagerly discussed politically. There was a call by president Cristina Fernandez de Kirchner to create a commission to investigate agrochemicals in 2009, but its final recommendation, as IPS notes, was, "Because there is not enough data in Argentina on the effects of glyphosate on human health, it is important to promote further research."

The media is not crazy about it either, and you can see why by flipping the pages of the Country supplements from the nation's major newspapers, filled with ads from Monsanto et al. In 2009, a local scientist presented a study with evidence of the impact of glyphosate on amphibious embryos and received death threats plus an aggressive discredit campaign.

But this afternoon, Gatica and other environmental movements pushing the issue were preparing to receive a pat in the back. A court in Cordoba Province was going to give its final ruling on whether two farmers and an aviator were guilty of causing environmental damage and potential health hazards to the people of Ituzaingo.

Five hours after the initial time of the announcement, the verdict was in: one farmer was absolved due to lack of evidence, but the other and the aviator were found guilty and sentenced to three years of jail. Well, actually, conditional jail. Which means they can very much get out of doing any time, although they will be obliged to do social work.

Read more.. http://www.treehugger.com/environmental-policy/a-landmark-ruling-against-agrochemicals-in-argentina-receives-mixed-reactions.html

Wednesday
Jul182012

BAD TO THE BONE - Fraud IS the Business Plan

by Gary Null, Ph.D. and Nancy Ashley, VMD

Part I – 

You would have thought the way the stock price rose on Monday, July 2, 2012, that good news had been reported about British company GlaxoSmithKline instead of the announcement that the company had agreed to plead guilty to misdemeanor charges and pay a $3 billion criminal settlement to settle the largest case of healthcare  in U.S. history. In fact, the settlement was previously disclosed by GSK to its shareholders and was at least $150 million lower than expected. Not only is this a relatively paltry sum for a company which brings in $45 billion a year in revenue, but it essentially allows Glaxo to be absolved of its many crimes, and the injuries and deaths resulting from its dangerous pharmaceuticals over the past decade. It used to be that in most cases, a  settlement of more than a billion dollars would destroy a company. But as we have repeatedly seen over the years, this is just a regular cost of doing business for the . Ultimately, this $3 billion fine is just a line item on GSK’s balance sheet.

 

The settlement, which breaks the previous record of $2.3 billion set by Pfizer in 2009, is nothing new for GlaxoSmithKline. According to a 2010 report by Public Citizen, since 1991 – around the same time as the infamous Prescription Drug User Fee Act (PDUFA) allowed drug companies to buy approval from the  — GSK has had to pay more in fines and settlements to the federal and state governments than any other pharmaceutical company: a total of $4.5 billion not counting this week’s $3 billion.

 

So what misdemeanors did Glaxo agree to plead guilty to?

 

Avandia – Failing to disclose safety data: fine $243 million

 

Glaxo brought Avandia (rostiglitazone) to market in May 1999 amid great fanfare, and it quickly became the best-selling diabetes drug in the world. There were signs early on that Avandia caused a significant increase in heart attacks, however, which were ignored and denied by the company and the . In the settlement, Glaxo was charged with failing to disclose the results of studies between 2001-2007 showing the increased risk of heart attack and death from Avandia. Additionally, Avandia has been linked to stroke, hepatotoxicity, bone fractures, and blindness. Nevertheless, because of aggressive marketing to medical professionals and clients alike, and despite the fact that reports of injury and death were hitting the mainstream media by 2007, sales of Avandia still topped $1.2 billion as late as 2009. The drug was completely taken off the market in Europe in 2010. Senators Grassley and Baucus tried to get the drug taken off the US market starting in 2008, but they were unsuccessful, despite the fact that the report they issued revealed that Avandia caused 500 unnecessary heart attacks a month in the US! The  held firm in their support of Avandia and GlaxoSmithKline even in the face of  charges in the panel members who voted in favor of it. Currently the use of Avandia in the US is restricted to those already using the drug, and it remains available to them despite the risks and despite the fact that there are dozens of similar drugs available.

 

Paxil and Wellbutrin – Introducing Misbranded Drugs into Interstate Commerce (Marketing antidepressants for unapproved uses): Fine $757 million

 

Paxil, (paroxetine) a selective serotonin reuptake inhibitor (SSRI) made by Glaxo’s predecessor, SmithKline Beecham (SKB), was approved for adult depression in 1992. Shortly thereafter, SKB started a multi-site study of Paxil for use in adolescent major depression. Study 392, which ended in 1997, showed that there was no significant difference between Paxil and placebo on ANY of the eight pre-specified outcome measures.It showed further that Paxil caused increased risk of suicide, self-harming behavior, and harm to others in the adolescents who took it, even as much as one single dose in certain susceptible individuals. The company, instead of taking any steps to protect , decided to manage the negative results by ignoring unfavorable data and presenting fabricated positive results instead through a ghostwritten article published in 2001 in the prestigious Journal of the American Academy of Child and Adolescent Psychiatry. SmithKlineBeecham decided that this was the best strategy to minimize any potential negative commercial impact, according to an internal document. On the strength of selectively reporting the evidence of study 329 in the JAACAP article, doctors began prescribing Paxil widely for adolescents, even though the FDA had never approved the drug for this purpose. It wasn’t long, however, before the drastic increase in suicides among adolescents taking Paxil became obvious. On June 10, 2003, the British medical authorities took decisive action and banned the use of Paxil in adolescents.13 Our own FDA, however, was less concerned, and added a black box warning advising of the risk of suicide in adolescents taking Paxil without banning the drug.14

Click to read more ...

Friday
Jun222012

GOV. NIKKI HALEY REJECTS GARDASIL: A MOMENT OF SANITY IN A SEA OF CORPORATE-SPONSORED CONFUSION

Nikki Haley, Governor of South Carolina, made headlines on Tuesday by vetoing a bill initiated by the Democrats which would provide sixth graders with government-sponsored information encouraging parents to get the human papillomavirus (HPV) vaccine for their children as well as one free HPV vaccine for seventh graders. Haley has received a barrage of criticism for her actions, and charges of hypocrisy for having previously sponsored a bill in 2007 that would have mandated the HPV vaccine in South Carolina, even though she ultimately withdrew her backing because the bill did not contain an opt-out provision. While the current bill had broad bipartisan support, Governor Haley rejected it as unnecessary and because it would be a precursor to a vaccine mandate entirely dependent on government funding. More importantly, however, Haley was quoted as saying her previous support of a human papillomavirus vaccine mandate was a mistake: now that she has a 14 year-old daughter she feels differently about “what I am going to do as a parent and what I want for my child.”1 While we support Governor Haley’s courage in standing up for a parent’s right to determine the health care given to their children, which is laudable, we would offer Governor Haley, along with every governor in America, every state and federal legislator, and every pediatrician, pharmacist, and nurse, a reality check. Mandating, or even encouraging or supporting, the human papillomavirus vaccine is tantamount to promoting a public health fraud, and intentionally and with malice aforethought, placing millions of young girls’ and boys’ lives at risk for debilitating injury, including death. Our public health policies, including vaccination, have been formed not by independent, qualified scientists, but rather by lobbyists who have paid for access to politicians at the state and federal levels, bringing forth hand-picked, highly compromised scientists and physicians to promote a fallacy and make it codified by law that the HPV vaccine will prevent cervical cancer and save countless lives when, in fact, independent science shows just the opposite. Therefore, we are offering you an opportunity to review actual scientific evidence that would convince any responsible and reasonable parent, politician, or physician that this vaccine should be banned, not mandated. While the Democrats in South Carolina moan about lost opportunities to save lives and to cut back on health care costs, what they seem clueless and grossly irresponsible about are the facts; once again allowing ideology to trump science. Even Governor Jerry Brown of California, demonstrated his unbridled promotion of the Gardasil vaccine by signing into law in October 2011, a bill which gives 12 year-old children the right to choose the HPV vaccine not only without parental approval, but without even parental notification!2 The scientific facts are that the HPV vaccine is dangerous, even deadly. The major HPV vaccine in question is of course, Gardasil, Merck’s premier product that has lifted it out of the financial doldrums since the ignominious removal of Vioxx from the market in 2004. We spoke with Cindy Bevington, an investigative journalist, who says we should all be very concerned about these repeated attempts to force Gardasil on our children because there is absolutely no proof that using this vaccine will lead to the prevention of cervical cancer. Bevington broke the story in 2007 that Dr. Diane Harper, the lead investigator for the clinical trials of both Gardasil and its competitor, Cervarix, considered the HPV vaccine to be not only unnecessary, but “a huge public health experiment.” Dr. Harper revealed to Bevington that the current rate of cervical cancer in the US is so low, that every single 12 year-old girl would need to be vaccinated for the next 60 years to reduce the rate of cervical cancer at all.3 The news was a disappointment to the legislative campaign to mandate Gardasil across the nation to 12-year old girls, which was being heavily pushed by Merck together with ALEC and their spokespeople, Women in Government. Since then, despite all the advertising, Gardasil is nowhere near as successful as Merck was hoping for. During the push to require Gardasil for children in Indiana, Bevington went to the hearings and observed Indiana legislators actually weeping, begging for the vaccine to be mandated as they spoke about lives lost to cervical cancer without it! Why have we become such an anti-scientific nation? We have been misled scientifically into believing that this vaccine will save lives when in fact the opposite is true. The remarkable claims of Gardasil’s benefits to women in the war on cancer are quite simply ridiculous, inaccurate, fraudulent, and are not supported by the science -- even that science funded by Merck itself. We could ask where is the New York Times, the Washington Post, the LA Times, CBC, Fox, or CNN? Where are the journalists and the resources they have at their disposal to uncover these facts? Is this a truth they do not want to know because they would then be forced to report it? The Gardasil story is just one example of the bias in official media, both conservative and liberal. Here, then, are 10 facts that would seem that no Governor, Federal official, or legislator has taken the time to study. If so, we would have a different approach to mandating Gardasil in the 50 states.

Click to read more ...

Wednesday
Jun062012

Ed Silverman - FDA Does A Poor Job Of Communicating Recalls

The FDA has two systems for alerting physicians to product recalls, yet 20 percent of recalls for Class I products – which are the likeliest to cause patient harm – were not communicated through either system between 2004 and 2011, according to an analysis published in the Archives of Internal Medicine. The upshot? Health care providers may not be aware of recalls that threaten patient safety, despite FDA efforts to upgrade its alerts.

“Drug recalls in the United States are common and often involve serious defects that pose health risks to patients. Given the large number of affected units per recall and the widespread distribution of these units, solutions are needed to minimize patient harm when recalls occur,” the researchers write. They note that recalls take place nearly once a month in the US and usually involve thousands of units of products distributed nationwide and beyond. Overall, the most common reason for the recalls were contamination and a wrong dose or release mechanism.

They researchers reached this conclusion after examining 1,734 recall entries in the FDA Enforcement Reports, of which 91, or 5 percent, were Class I recalls. During the same period, the FDA issued 2,912 Recall Alert System announcements, of which 166 were major human drug recalls for 126 unique products. Only 55, or 47 percent, were Class I recalls, but the agency did not a Recall Alert System notice for 36 of those, or 40 percent. Yet half of that group, or 18, were communicated through the Medwatch program, including all five recalls sent due to adverse events. However, 18 of the 91 Class I recalls, or 20 percent, were not communicated through either system (here is the paper).

Read More:

http://www.pharmalot.com/2012/06/fda-does-a-poor-job-of-communicating-recalls/

Tuesday
Jun052012

U.S. FDA checks dictionary on corn syrup vs sugar

U.S. food and beverage makers who add high-fructose corn syrup to soda, breakfast cereal and other items will not be able to label it "corn sugar," under a decision by federal officials that frustrated corn processors but won praise from the sugar industry and some health advocates.

Both sides say they have consumers' interests at heart and are trying to minimize confusion about the term "sugar."

The U.S. Food and Drug Administration, which decides what goes on food labels, has ruled against the corn groups. The agency said calling high-fructose corn syrup "sugar" would mislead people - and could harm them.

"FDA's approach is consistent with the common understanding of sugar and syrup as referenced in a dictionary," the agency said in a letter posted on its website late on Wednesday.

The United States is the biggest consumer and manufacturer of high-fructose corn syrup. The sweetener was added to beverages such as Coca-Cola in the 1980s, but in recent years food makers have been trying out a return to sugar after some studies linked corn syrup to obesity.

Read More:

http://www.reuters.com/article/2012/05/31/us-fda-sugar-idUSBRE84U19V20120531

Friday
Jun012012

Exercise and a Healthy Diet of Fruits and Vegetables Extends Life Expectancy in Women in Their 70s

Women in their seventies who exercise and eat healthy amounts of fruits and vegetables have a longer life expectancy, according to research published in the Journal of the American Geriatrics Society.

Researchers at the University of Michigan and Johns Hopkins University studied 713 women aged 70 to 79 years who took part in the Women's Health and Aging Studies. This study was designed to evaluate the causes and course of physical disability in older women living in the community.

"A number of studies have measured the positive impact of exercise and healthy eating on life expectancy, but what makes this study unique is that we looked at these two factors together," explains lead author, Dr. Emily J Nicklett, from the University of Michigan School of Social Work.

Researchers found that the women who were most physically active and had the highest fruit and vegetable consumption were eight times more likely to survive the five-year follow-up period than the women with the lowest rates.

Read More:

http://www.sciencedaily.com/releases/2012/05/120530100512.htm

Wednesday
May302012

Sayer Ji - Eating Aluminum: Is It As Safe As Our Regulators Say?

Aluminum toxicity, a characteristically manmade problem, is now impossible to avoid, and has become a postmodern rite of passage. Our environment has become so polluted with the stuff, that even our crop plants are being threatened, with biotechnology firms now scrambling to genetically engineer aluminum-tolerance into them as a possible, though still desperate solution.

Not only are we being exposed, daily, through increasingly polluted water, soil and air, but many of our regulatory agencies consider it perfectly safe to intentionally consume or inject the stuff directly into our bodies.

While there is no known physiologic need or positive biological role for aluminum in the human body, the FDA is perfectly content with the population it is charged with protecting eating it as a "food grade" additive. This same "regulatory agency" promotes the mythical concept of a "safe" food grade petroleum, allowing food manufacturers to surreptitiously feed us over half a pound a year, which is likely why human autopsies have revealed that almost half of us have pathological deposits of the stuff in our livers and spleen.*

Technically, there are 8 forms of aluminum the government considers benign enough to receive GRAS, or Generally Recognized As Safe, status - a designation which basically exempts the substance from adequate safety testing. Those 8 forms are:

Read More:

http://www.greenmedinfo.com/blog/eating-aluminum-it-safe-our-regulators-say

 

Wednesday
May232012

FDA, Under Court Order, Nevertheless Refuses to Allow Truthful Claims Based on Good Science

You would think the FDA would obey a judge’s ruling on qualified health claims. Think again.

The FTC case described elsewhere in this issue [1] was especially important because the FDA was hoping to use the FTC to evade some recent court rulings that it cannot willfully and unreasonably censor all science about food and supplements. Meanwhile the FDA continues to dig in its heels on the same subject.

As you know, we have for some time been fighting for freedom of speech with the FDA. Supplement and food companies are allowed by law to makequalified health claims (QHCs) on their labels [2] if they are approved by the FDA. However, QHCs are rarely approved by FDA, and when they are, the FDA-approved language usually undermines the meaning. Because of their denial of two health claims (that vitamin C reduces the risk of gastric cancer, and the vitamin E reduces the risk of bladder cancer), we took FDA to court—and won [3].

FDA was then ordered by the court to revise those QHCs. They did, and we have just received the revised versions—and they are as bad and intentionally misleading as before! The new QHCs all have the qualifier that “FDA has concluded there is very little scientific evidence for this claim.” Example: “Vitamin C may reduce the risk of gastric cancer although the FDA has concluded that there is very little scientific evidence for this claim.”

Frankly, we find this outrageous. It is clear that the FDA, in crafting these revised QHCs, has chosen to ignore the recent precedent set in the green tea case [2], where the judge stated that the FDA-approved QHC “effectively negates the substance–disease relationship claim altogether….There are less burdensome ways in which the FDA could indicate in a short, succinct and accurate disclaimer that it has not approved the claim without nullifying the claim altogether.”

Read More:

http://www.anh-usa.org/fda-refuses-to-allow-truthful-claims

Wednesday
May232012

EU Food Agency Rejects France Ban on Monsanto's YieldGuard GM Maize

Europe's food safety agency EFSA on Monday rejected the grounds for a temporary French ban on a genetically modified strain of maize made by U.S. company Monsanto (IW 500/94).

"Based on the documentation submitted by France, there is no specific scientific evidence, in terms of risk to human and animal health or the environment," EFSA said in a scientific opinion issued on its website.

A spokesman for Europe's health commissioner John Dalli said the EU executive "will consider how to follow up on this ruling, though technically we could ask France to raise its ban" on MON 810.

"The commission will wait for the conclusions of the next environment ministers' meeting June 11 in Luxembourg and hopes for a positive outcome to its proposals for cultivation, which have been blocked for almost two years by France and others," spokesman Frederic Vincent told AFP.

Paris had asked Brussels in February to suspend the cultivation of MON 810 on the basis of new scientific evidence after France's top administrative court in November overturned a government order banning the planting of genetically modified crops from Monsanto.

The court said that in a November 2008 ban, the government had failed to prove that Monsanto crops "present a particularly elevated level of risk to either human health or the environment."

Read More:

http://www.industryweek.com/articles/eu_food_agency_rejects_france_ban_on_monsantos_yieldguard_gm_maize_27415.aspx?Page=1&SectionID=2