Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Friday, October 19, 2012

More drugs may be linked to meningitis outbreak: FDA

(Reuters) - Two other drugs made by the Massachusetts pharmacy at the center of a deadly meningitis outbreak may be linked to the disease, U.S. health regulators said on Monday, potentially widening the scope of the health crisis.

The Food and Drug Administration said it was looking into reports of a patient with possible meningitis who received an injection of a different steroid than the one found to have caused 15 deaths. It also said two transplant patients were infected with the rare fungus linked to the meningitis outbreak after receiving a heart drug also made by the New England Compounding Center (NECC) of Framingham, Massachusetts.

Nine more people have been diagnosed with fungal meningitis linked to possibly tainted vials of the injected steroid methylprednisolone, bringing the number of cases to 212, according to the U.S. Centers for Disease Control and Prevention (CDC). A Tennessee woman among these cases filed a lawsuit on Monday against NECC seeking $15 million in damages.

Read more here: http://www.reuters.com

Wednesday, June 06, 2012

Dangers of artificial food colors

"Should the FDA be so permissive with chemicals in food, suspect or not, that amount to little more than marketing?" asks The Daily Green (http://www.thedailygreen.com/healthy-eating/eat-safe/artificial-food-...). This question is particularly pertinent considering that colorings have not always proven to be harmless.

Citrus Red 2, Red 3, Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2 and Green 3, --which include some of the most commonly used artificial food colorings--have all been identified as being, or being contaminated with, potential cancer-causing chemicals, according to the Center for Science in the Public Interest. And Blue 1, Red 40, Yellow 5, and Yellow 6 are known to trigger reactions in those with allergies.

History paints an ugly food color portrait

Until the twentieth century, food coloring could only be obtained from what people found in nature. Ancient Romans used saffron and other spices to put a rich yellow color into various foods (http://homecooking.about.com/od/foodhistory/a/foodcolorhistry.htm). Other frequently used natural colors included paprika, turmeric, beet extract, and petals of various flowers.

But many of the other frequently used natural colors were not only unappetizing, but downright dangerous (http://onlinelibrary.wiley.com/doi/10.1111/j.1541-4337.2009.00089.x/p...). Bakers added chalk to whiten bread, for example, and sweets manufacturers loaded candy with vermilion (which contains mercury), red lead, white lead, verdigris (which is a copper salt), blue vitriol (which contains copper) and Scheele's green (which contains both copper and arsenic).

The science of food coloring evolved from there and technology created a new kind of dye derived from coal tar, a waste product of coal gas and coke. The synthetic dyes came to be known at coal-tar colors and they are what we still use today.

By the beginning of the 20th century, some 695 of these had been synthesized, and over 80 were on the market. While they were generally a safer alternative to metal salts and used in less quantity, they were still unregulated.

In 1938, responsibility for regulating and enforcing color was granted to the newly instituted Food and Drug Administration. At that point, there were 15 synthetic colors approved for use in foods, 6 of which are still used today.

Modern food colorings have their own problems

While manufacturers were no longer adding mercury or arsenic to their products, food-coloring dangers took center stage, yet again, in the 1950s after many children became ill from eating Halloween candy containing the Orange 1 food coloring. The FDA banned the color after more rigorous testing suggested that it was toxic (http://www.nytimes.com/2011/03/30/health/policy/30fda.html).

Red 32 and Orange 2 were also delisted due to the same Halloween incident, according to the Harvard Law School paper, The Palette of Our Palates: A brief history of food coloring and its regulation.

The controversy continued when, in 1976, the agency banned Red 2 because it was suspected to be carcinogenic, according to The New York Times (http://www.nytimes.com/2011/03/30/health/policy/30fda.html).

Other colors have since been banned in the US including: Violet 1; Reds 2 and 4; Yellows 1, 2, 3 and 4, and Yellow 5 is undergoing testing, according to Encyclopedia Britannica (http://www.britannica.com/EBchecked/topic/212658/food-colouring).

The FDA decided to remove Red 2 from the provisional list in 1976, after Conflicting studies were published. Some studies showed the dye was safe and others showed that it was not safe and, in fact, caused breast and intestinal tumors in rats and was toxic to gonads and embryos. The FDA de-listed it stating that the color industry had not met its burden of proving the safety of Red 2.

Yellow 5 was the successor to Red 2 in popularity. The color, sometimes called Tartrazine, also had its own problems. It was one of the dyes singled out in 1977 by Ralph Nader's Public Citizen Health Research Group as unsafe. The group pointed to the de-listing of Red 2 and Red 4 a year earlier as evidence that dyes we consider "safe" are often later shown to be toxic.

While the FDA said that Public Citizen was "overstating the issue and causing public alarm that is simply not warranted," they simultaneously admitted that Yellow 5 caused severe allergic reactions in a small number of people.

Is the FDA doing a better job today?

The FDA suggested that problems associated with artificial coloring might be akin to a peanut allergy or intolerance to these substances and not to any inherent toxic properties of the colorings themselves, said the New York Times.

This may not be accurate, according to a 2004 Southampton University study covered by the BBC. A team of researchers found that adding food colors to children's diets increased hyperactivity rates in all young children, not just those who were allergic to food colorings or who had Attention Deficit Hyperactivity Disorder (http://news.bbc.co.uk/2/hi/health/3742423.stm).

"I want this to address a fundamental issue which is 'Why do we have to have colored food?' said Professor John Warner, the study's author.

"It's absolutely imperative to have follow up studies because we are not now just talking about a population of children with a particular problem we are saying there's a potential for this to be an effect on all children," he said. "And, if that really is the case, then food coloring should be removed."

Consumers can avoid synthetic food colorings by checking labels in grocery stores or by shopping at chains like Whole Foods Market and Trader Joe's, which refuse to sell foods with artificial coloring.

Sources for this article include
http://onlinelibrary.wiley.com/doi/10.1111/j.1541-4337.2009.00089.x/p...
http://www.britannica.com/EBchecked/topic/212658/food-colouring
http://www.thedailygreen.com/healthy-eating/eat-safe/artificial-food-...
http://www.nytimes.com/2011/03/30/health/policy/30fda.html
http://news.bbc.co.uk/2/hi/health/3742423.stm
http://www.heartland.org/healthpolicy-news.org/article/29857/Group_Ca...
http://homecooking.about.com/od/foodhistory/a/foodcolorhistry.htm

Friday, May 25, 2012

Breaking news: US Senator Rand Paul offers surprise amendment to rein in FDA abuses, disarm the FDA, decriminalize free speech

In a stunning and completely unannounced move, US Senator Rand Paul -- who many agree represents the best hope for the restoration of liberty in America -- has introduced an amendment to a key FDA funding bill that seeks to sharply rein in the FDA's power. It would disarm the FDA and make the agency stop using guns against the American people; it would halt the FDA's armed raids on raw milk farmers; it would also stop the FDA's outrageous and longstanding censorship of truthful health claims of dietary supplements and medicinal herbs.

This is a big deal. While it may not pass, given its sudden introduction and lack of enough time to build grassroots support, the very fact that U.S. Senator Rand Paul has introduced such an amendment is proof positive that Rand Paul is exactly the kind of leader that can help take our nation out of the age of government tyranny and censorship and into a new era of transparency, accountability and liberty. Ending the FDA's unconstitutional censorship of truthful health claims could, without question, help prevent disease and greatly reduce the out-of-control health care costs that are bankrupting America.

Here is the full text of the announcement from Sen. Rand Paul's website:

Sen. Rand Paul's press release

Today on the U.S. Senate floor, Sen. Rand Paul introduced an amendment to the Food and Drug Administration User Fee Reauthorization bill, which would curb the Food and Drug Associations overreach and abuse of power. Sen. Paul's amendment, No. 2143, would disarm the FDA, put an end to raids on natural food stores and Amish farmers, and stop FDA censorship of truthful claims of dietary supplements.

Below is the video and transcript of his speech, as well as top-line points and background information regarding Sen. Paul's amendment.

Watch a video of his speech at:
http://www.youtube.com/watch?v=kT8waPM9yYw

ACTION ITEM: Post your comments in support of this on YouTube! We need to hammer YouTube with positive comments from people demanding health freedom and the end of FDA tyranny.

TRANSCRIPT:
President, today I'm offering an amendment to the FDA. I'm troubled by images of armed agents raiding Amish farms and preventing them selling milk directly from the cow. I think we have bigger problems in our country than sending armed FDA agents into peaceful farmers' land and telling them they can't sell milk directly from the cow.

My amendment has three parts. First, it attempts to stop the FDA's overzealous regulations of vitamins, food and supplements by codifying the first amendment prohibition on prior restraint. What do I mean by that?

The first amendment says you can't prevent speech, even commercial speech, in advance of the speech. You can't tell cheerios that they can't say there's a health benefit to their Cheerios. Under our current FDA laws, FDA says if you want to market prune juice, you can't say that it cures constipation.

You can't make a health claim about a food supplement or about a vitamin, you can do it about a pharmaceutical, but you're not allowed to do it about a health supplement.

I think this should change. There have been several court cases that show this goes against not only the spirit but the letter of the law of the First Amendment. So this amendment would change that.

This amendment would stop the FDA from censoring claims about curative, mitigative effects of dietary supplements. It would also stop the FDA from prohibiting distribution of scientific articles and publications regarding the role of nutrients in protecting against disease.

Despite four court orders condemning the practice as a violation of the First Amendment, the FDA continues to suppress consumers' right to be informed and to make informed choices by denying them this particular information. It's time for Congress to put an end to FDA censorship.

Second, my amendment would disarm the FDA.

Now, some of you might be surprised the FDA is armed. Well, you shouldn't be.

We have nearly 40 federal agencies that are armed. I'm not against having police, I'm not against the army, the military, the FBI, but I think bureaucrats don't need to be carrying weapons and I think what we ought to do, is if there is a need for an armed policeman to be there, the FBI who are trained to do this should do it. But I don't think it's a good idea to be arming bureaucrats to go on the farm to, with arms, to stop people from selling milk from a cow.

I think we have too many armed federal agencies, and that we need to put an end to this. Criminal law seems to be increasing, increasingly is using a tool of our government bureaucracy to punish and control honest businessmen for simply attempting to make a living.

Historically the criminal law was intended to punish only the most horrible offenses that everyone agreed were inherently wrong or evil, offenses like rape, murder, theft, arson - but now we've basically federalized thousands of activities and called them crimes.

If bureaucrats need to involve the police, let's have them use the FBI, but I see no reason to have the FDA carrying weapons.

Today the criminal law is used to punish behavior such as even fishing without a permit, packaging a product incorrectly or shipping something with an improper label.

Simply said, the federal government's gone too far.

The plain language of our Constitution specifies very few federal crimes. In fact, the Constitution originally only had four federal crimes and now we have thousands of federal crimes.

We've moved beyond the original intent of the Constitution. We don't even know or have a complete list of all the federal crimes. It's estimated there are over 4,000, but no one has an exact number.

Finally, my amendment will require adequate mens rea protection. In other words, when you have a crime, you're supposed to prove the intent. People have to have intended to harm someone, it can't be an honest mistake where a businessman or woman have broken a regulation and didn't intend to harm someone. If you want to convict someone of a crime and put them in jail, it should be a mens rea requirement.

This is something we have had for hundreds of years, it comes out of our common-law tradition.

This amendment would fix this problem by strengthening the mens rea component of each of the prohibited acts and the FDA acts by including the words "knowing" and "willful" before we address and accuse someone of a crime.

This I think would give protection to folks who are guilty of inadvertently guilty of breaking a regulation and would keep from overflowing our jails. We've got plenty of violent criminals without putting people in for honest breaches of regulations. If Congress is going to criminalize conduct at the federal level as it does with the FDA act, the least it can do have is have an adequate mens rea requirement. My amendment will attempt to do this.

It's not that we won't have rules at the federal level, but the rules ought to be reasonable. We ought to allow people to market vitamins. There's no earthly reason why somebody who markets prune juice can't advertise it helps with constipation.

We've gone too far, and we've abrogated the First Amendment and what we need to do is tell the FDA that the courts have ruled that the First Amendment does apply to commercial speech and the FDA has been overstepping their bounds.

TOP-LINE POINTS

Paul Amendment #2143 to S. 3187, the Prescription Drug User Fee Act

Part I: Health Freedom Act -

The amendment forces the FDA to at last comply with the commands of Congress, the First Amendment, numerous federal courts, and the American people by codifying the First Amendment prohibition on prior restraint.

Stops the FDA from censoring truthful claims about the curative, mitigative, or preventative effects of dietary supplements.

Stops the FDA from prohibiting the distribution of scientific articles and publications regarding the role of nutrients in protecting against disease.

Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a food to be misbranded only when its label includes a claim adjudicated to be false and/or misleading.

Part II: Prohibitions on FDA Officials Carrying Firearms and Making Arrests Without Warrants

This section disarms FDA agents (and any and all employees of HHS).

Background:

The plain language of our Constitution specifies a very limited number of federal crimes. These include treason,[1] counterfeiting,[2] piracy or felonies on the high seas,[3] and offenses against the laws of nations.[4]

Yet today, we have over 4,450 criminal offenses in our federal statutes alone. This number does not include the thousands of criminal offenses scattered throughout federal regulations.

In order to enforce all these crimes, we've armed our federal agencies, and there are now over 30 federal agencies that have employees authorized to carry firearms and use them.

This cycle of criminalizing everything at the federal level and then arming all of our federal agencies needs to stop.

Recent FDA armed raids of Amish dairy farmers selling "raw" milk directly from the cow present high-profile examples of why we need to have fewer armed federal agents (and fewer federal crimes).

Part III: Mens Rea Component/Reform -

This section amends the "Prohibited acts" section of the Federal Food, Drug and Cosmetic Act (21 USC SS 331) to strengthen the mens rea ("guilty mind") component of each of the prohibited acts. It adds the words "knowing and willful" to each of the prohibitions.

Background:

In 2010, the Heritage Foundation and the National Association of Criminal Defense Lawyers conducted a study and issued a report regarding the problem of not only the massive proliferation of federal criminal law in general, but particularly the erosion of any meaningful mens rea ("guilty mind") component to these federal laws.

This report-Without Intent: How Congress Is Eroding the Criminal Intent Requirement in Federal Law-found that over 57% of the offenses considered by the 109th Congress alone contained inadequate mens rea requirements, putting the innocent at risk of criminal punishment. The study also discovered consistently poor legislative drafting and broad delegation of Congress's authority to make criminal laws to unelected officials in administrative agencies-"criminalization by regulation."

If Congress is going to criminalize conduct at the federal level as it does in the Food, Drug and Cosmetic Act, then the least it can do is include an adequate mens rea component. 

Tuesday, May 22, 2012

FDA accused of mass homicide of one million Americans each decade

The biggest threat to America today is not terrorists or global warming, but the mass genocide of Americans who die every year at the hands of the corrupt U.S. Food and Drug Administration (FDA). In a recent report, investigative reporter Jon Rappoport uncovers the dirty truth that FDA-approved drugs kill at least 100,000 people every single year -- the FDA actually lists this figure on its own website -- and the agency is doing absolutely nothing about this disastrous trend.

On a webpage entitled Why Learn about Adverse Drug Reactions (ADR)?, the FDA admits that 100,000 people die every single year as a result of taking FDA-approved pharmaceutical drugs. Citing figures from three different published studies, the figures also reveal that two million people a year suffer from serious ADRs, which include things like stroke, heart attack, and permanent neurological damage.

You can view the FDA page for yourself here:
http://www.fda.gov

Since these figures come from studies dating back to at least 1998, it is clear that the FDA is fully aware of the extensive harm being caused by supposedly "safe" drugs. And since it has done nothing to address the problem, the agency is complicit in willfully harming and murdering tens of millions of Americans throughout just the past several decades, which makes it one of the most murderous government regimes in history.

Based on the figures presented by the FDA, at least 30 million people have suffered serious injury or death as a result of taking FDA-approved drugs just since 1998 when the first cited study was published. If you go back several more decades, it is clear that potentially hundreds of millions of people have been directly harmed by the FDA's "negligent homicide."

"It is time for these murderous government crimes to end," writes Rappoport in his report. "It is time for all responsible parties to be brought to justice, to real justice. It is time for the public to realize that 100,000 people dying every year in the U.S., because they take medical drugs, is the equivalent of 33 airliner crashes into the Twin Towers, every year, year after year."

Why the FDA and its drug lords are the real terrorists

Since the FDA is the official gatekeeper of pharmaceutical drugs, it is directly responsible for the harm they cause. And yet agency officials have never, in any meaningful way, been held responsible for their crimes against humanity. And the U.S. Department of Justice (DOJ), as Rappoport points out, has failed to step in and pursue those responsible for peddling poison as medicine.

If al-Qaeda operatives were caught dispensing toxic chemicals disguised as medicine to innocent civilians, they would be sent off to Guantanamo Bay without trial, and locked away indefinitely. But when the FDA does the very same thing on a much more massive scale, nobody bats an eye. And yet the number of people that the FDA has killed with its drugs is far more than the number killed during 9/11 or the Oklahoma City bombing.

The organized crime ring that is the federal government today is the real terrorist threat that we all face on a daily basis. And until the American people collectively wake up to this reality, we will continue to watch our friends, our families, and our children, which are the casualties of this ongoing terrorist attack, lay waste at the hands of Big Pharma and the FDA.

Sources for this article include:

http://jonrappoport.wordpress.com

http://www.naturalnews.com/030461_Senate_Bill_510_Food_Safety.html

Wednesday, January 25, 2012

Repeat business? FDA approves new cancer drug to treat toxicity caused by another cancer drug

The US Food and Drug Administration (FDA) has approved a new cancer drug that allegedly treats the deadly side effects caused by another popular cancer drug. The new drug, Voraxaze (glucarpidase), is said to expel methotrexate, a commonly prescribed and highly toxic chemotherapy drug, from the body. But Voraxaze comes with its own set of harmful side effects, which shows that approving drugs to treat the side effects of other drugs is an endless, but highly profitable, cycle of toxicity.

Methotrexate's known side effects include kidney and liver destruction, skin rashes, mouth sores, damaged intestines, and death. The drug often lingers in the body following cancer treatments, as weakened organs become increasingly incapable of expelling it from the body. So to "fix" this problem, the FDA has decided to approve another drug that it says breaks down methotrexate and eliminates it from the system.

But Voraxaze, which is made from genetically-modified (GM) enzymes, carries with it harmful side effects of its own, including hypertension, arrhythmia, allergic dermatitis, nausea, and vomiting. And these are just the short-term side effects observed among a small clinical trial group of just 290 patients, which is the only trial that has been conducted evaluating the safety of Voraxaze.

Worse, Voraxaze received "fast-track" approval from the FDA based on a single clinical study of just 22 patients, which allegedly evaluated the drug's effectiveness. By all reasonable scientific standards, a single study with this ridiculously small amount of participants can hardly be considered a valid indicator of a drug's efficacy (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm287997.htm).

Contrast this with mainstream medicine's rejection of at least 24 separate studies, all with much larger sample sizes, that have identified a clear and definitive link between fluoride consumption and disease in recent days. "Further research" is always necessary when the issue involves proving fluoride's toxicity, or proving the benefits of an herbal or dietary supplement. But when a new drug is up for approval, one small, industry-funded study is enough for regulators.

So thousands of cancer patients who become poisoned by methotrexate, which is also used to treat psoriasis and arthritis patients, will also now receive an intravenous dose of GM enzymes that have never been definitively proven either safe or effective. Leave it to the FDA to once again pander to Big Pharma at the expense of public health.

Source for this article include:

http://www.reuters.com/article/2012/01/17/us-fda-voraxaze-idUSTRE80G2FE20120117

Friday, January 06, 2012

America's Toxic Flu shots: 250 times EPA mercury limit

Thimerosal is a widely used vaccine preservative that is present in the majority of flu shots and other vaccines. Thimerosal is 49% mercury by volume, an extremely toxic chemical element that wreaks havoc on the nervous system, neurological function, and overall biological function [1]. Each dose of flu vaccine contains around 25 micrograms of thimerosal, over 250 times the Environmental Protection Agency's safety limit of exposure.

Mercury, a neurotoxin, is especially damaging to undeveloped brains. Considering that 25 micrograms of mercury is considered unsafe by the EPA for any human under 550 pounds, the devastating health effects of mercury on a developing fetus are truly concerning.

Though thimerasol is not entirely mercury, the mercury content is still extremely high, making it very toxic to the human body. Despite highly exceeding the EPA safety standards for mercury content by over 250 times, flu shots are still recommended for children over 6 months and pregnant women.

It seems that the age groups that are urged to receive the flu shot are actually most affected by mercury exposure. Young children, pregnant women, and elderly are the 'targeted' demographic of flu shot manufacturers, and these individuals also happen to have the least defense against the elemental neurotoxin mercury.

Dr. Russel Blaylock, a
leading neurologist, explains:

A recent study looked at the immune reaction in newborn infants up to the age of one year who had received the HepB vaccine to see if their immune reaction differed from adults getting the same vaccine. What they found was that the infant, even after age one year, did react differently. Their antibody levels were substantially higher than adults (3-fold higher) and it remained higher throughout the study.

In essence, they found that the babies responded to the vaccine by having an intense Th2 response that persisted long after it should have disappeared, a completely abnormal response.

In 2004, the The Coalition for Mercury-free Drugs petitioned the FDA to limit the use of thimerosal in vaccine citing safety concerns. In a reply made public years later, the FDA denied the request despite overwhelming evidence that mercury is harmful to the human body [2] [3] [4].

In addition to mercury, vaccines also contain other toxic fillers and preservatives that have been linked to
health conditions such as cancer:

-- Aluminium: Also a neurotoxin, aluminum has been linked to Alzheimer's disease [5] and other cognitive diseases [6].

-- Formaldehyde: Among the 8 new substances to be added to the U.S. Department of Health and Human Services list of carcinogens.

-- Antibiotics: Various forms include neomycin, streptomycin, and gentamicin.

-- Triton X-100: A detergent that should not be injected into the human bloodstream.

By recommending flu shots to the public, the CDC and vaccine manufacturers are ignoring the warnings of not only major studies conducted by prominent universities, but also the EPA. The EPA's safety limit of mercury exposure is being exceeded by over 250 times each shot. In addition to a number of other 'recommended' vaccines, flu shots are dished out each year to the public, meaning that this exposure increases to 250 times the limit each year. Over a 10 year period, it is possible to exceed the limit by 2500 times simply by receiving a yearly flu shot.

Sources:
1. Frustaci A, Magnavita N, Chimenti C, et. al; Marked elevation of myocardial trace elements in idiopathic dilated cardiomyopathy. J Am Coll Cardiology 1999;33:1578-83
2. Chang YC, Yeh C, Wang JD. Subclinical neurotoxicity of merucyr vapor revcelaed by a multimodality evoked potential study of chloralkali workers. Amer J Ind Med 1995;27(2):271-279.
3. Yang Y-J, Huang C-C, Shih T-S, et al . Chronic elemental mercury intoxication:clinical and field studies in lampsocked manufacturers. 1994;Occup Environ Med 57(1):245-247.
4. Bluhm RE, Bobbitt RG, Wlech LW, et al. Elemental mercury vapour toxicity, treatment and prognosis after acute intensive exposure in chloraklali plant workers. Part 1I. History, neuropsychological findings and chelator effects. Hum Exp Toxicol 1992 11(3):201-210.
5. Bertholf, R. Aluminum and Alzheimer's disease: prospectives for a cytoskeletal mechanism. CRC-Crit Rev Clin Lab Sci 25:195, 1987
6. Krishnan, S. Aluminum toxicity to the brain. Sci Total Environ 71:59, 198

Internet site reference: http://www.sott.net/articles/show/235750-Flu-Shots-Contain-More-than-250-Times-the-EPA-s-Safety-Limit-for-Mercury