April 18, 2014

FDA: Vaccines more than other drugs most likely to be removed from the market due to safety issues

rejected vaccine FDA: Vaccines more than other drugs most likely to be removed from the market due to safety issues

by Dr. Mercola

The most up-to-date list of recalled drugs is available on the U.S. Food and Drug Administration’s (FDA) drug recall web site.There you can find an ongoing list of drugs that have been removed from the market; generally these are “Class I” recalls, which means there is a “reasonable probability that the use of or exposure to violative product will cause serious adverse health consequences or death.” As a whole, recalls of prescription and over-the-counter drugs are surging in the United States, but a new report highlighted a trend emerging over recent years, showing that biological products and biologics, particularly vaccines, have been subject to a large, and growing, number of recalls.

More Than a Dozen Vaccine Recalls…

An in-depth analysis conducted by GBI Research looked at the number of recalls for biologics from 2007-2010.ii

Biologics are drugs that contain an ingredient extracted from a “biological” source, such as cells from humans, animals, or microorganisms.

As Pharmaceutical Online reported:
“Biological products and biologics have definite risks, as they are often only partially understood at the time of approval, with a highly complex production and purification process.”

From 2004-2010, GBI Research found that biologics recalls significantly increased, but those for vaccines and immunoglobulins were higher than any other drug classes.

From 2007 to 2010, 14 recalls for vaccines and 13 recalls for immunoglobulins were made, for reasons such as:

  • Serious adverse events
  • Labeling errors
  • Quality defects (reduced levels of potency, presence of contaminants, such as glass particles, etc.)
  • Manufacturing defects

Drug recalls are soaring to unacceptably high levels. As CNN reported in 2010, between 2006 and 2009 recalls kept inching upward, only to spike dramatically between 2008 and 2009, from 426 recalls to 1,742.iiiThat’s an increase of 309 percent in one year!

A single drug repacker, which has since been shut down, accounted for over 1,000 of those recalls, but even if you discount that one rotten apple, drug recalls still rose by over 50 percent. Drug companies have fiercely defended virtually every single drug ever recalled as being safe and effective — until definitively proven dead wrong, and sometimes they still wouldn’t fess up to their culpability. The same shameless, misleading strategies used for drugs are being used for vaccines. But with vaccines, the subsequent liability for the drug company has been greatly reduced or even eliminated!

When You Get a Vaccine, You Take All the Risk

From a drug maker’s perspective, vaccines may be one of the absolute “safest” products to make and sell, because civil liability is negligible to non-existent, depending on the vaccine and so profits are unlimited. Congress and the U.S. Supreme Court have guaranteed vaccine manufacturers a free pass in the civil court system if the vaccine they make and sell in the U.S. ends up crippling or killing a child or adult. (Pediatricians and other medical workers giving vaccines are also protected from civil liability if vaccines hurt someone they vaccinate).

Pandemic vaccines are 100 percent risk-free for the vaccine maker, because the pharmaceutical industry lobby made sure that laws were passed by Congress after 9/11 that exempted them from ANY liability for injuries and deaths caused by government-recommended vaccines used to counter “bioterrorism” or potential pandemics. And, making matters worse, these kinds of liability protection laws create a negative incentive to test vaccines for safety because if vaccine manufacturers are fully aware of the ability of their vaccine to injure or kill people and withhold that information from FDA regulators, then that is the one instance in which they COULD potentially be held legally liable for willful misconduct! It’s in their best interest to know as little as possible about the adverse reactions their vaccines might cause.

Non-pandemic vaccine injuries fall under the National Childhood Vaccine Injury Act of 1986, which is a no-fault federal vaccine injury compensation program. Two out of three vaccine injured victims are turned away for federal compensation under this program. As explained in this previous article, the program has been so poorly implemented since it was created by Congress that it is considered to be a sham by many parents, whose injured children are left out in the cold with no financial support after vaccine risks turn out to be 100 percent for them.

There is no system of “checks and balances” in the U.S. when it comes to vaccine safety oversight to ensure that the least toxic vaccines and the least harmful vaccine policies are being recommended by public health agencies and doctors. Vaccines are not adequately tested for safety and effectiveness using methodologically sound scientific studies before they are licensed, so all of their side effects and long-term negative health outcomes are unknown. Moreover, the effects of multiple vaccines given together or given repeatedly over time have not been adequately tested. And government health agencies or pharmaceutical companies have financed nearly all vaccine research to date, which introduces enormous bias.

So the fact that vaccine manufacturers are totally shielded from liability and accountability in civil court for vaccine injuries and deaths is alarming. Most recently, in February 2011, the U.S. Supreme Court gave the drug companies total immunity from lawsuits — even if they could have made a vaccine less harmful!

Barbara Loe Fisher, president of the National Vaccine Information Center, www.NVIC.org, explains:
“So if your child is brain injured by a vaccine that you may not have wanted your child to get in the first place, all you can do is file a claim in the federal vaccine injury compensation program. Even though the program has awarded more than $2 billion dollars to vaccine victims, two out of three plaintiffs are turned away empty handed.”

From Plastic Shrink Wrap to Pig DNA – What’s Lurking in Your Vaccines?

With all these recalls occurring, how can any health-conscious consumer trust the safety or the effectiveness of drugs and vaccines? The truth is, you have every right to know about and question the ingredients in vaccines being offered to your children, as contamination leading to recalls can and does occur.

For instance, an FDA inspection report from April 2011 of Merck’s biggest vaccine-making plant found bits of charred plastic shrink wrap in vaccine vials — and this was not a new or isolated occurrence. At least 12 reports had been submitted to the FDA from Merck regarding shrink wrap in vaccines since November 2009, and eight of these came from consumer complaints.iv The April report noted that the shrink wrap was reportedly not removed during a washing process and was then charred during a sterilization process. The agency also noted that health risks from the plastic in vaccines could not be ruled out.

Vaccine contamination such as this is a very real threat. In 2010, a research team discovered that GlaxoSmithKline’s Rotarix vaccine was contaminated with “a substantial amount” of DNA from a pig virus, and this was after 1 million U.S. children, and about 30 million worldwide, had already received it. At the same time, a measles vaccine was also found to contain low levels of the retrovirus avian leukosis virus, and Rotateq, Merck’s rotavirus vaccine, was found to contain a virus similar to simian (monkey) retrovirus.

It certainly makes you wonder what other “unknown” contaminants and other safety issues are lurking in vaccines, as it’s often only after significant health problems or deaths occur that a formal recall is made.

Is There a Better Way to Stay Well?

Unsafe vaccines and drugs will continue to enter the marketplace as long as drug companies are allowed to simply maintain the status quo — despite being caught lying, defrauding, even knowingly causing the deaths of people using their products, time and time again. Even under the best circumstances, every drug and vaccine carries an inherent risk of injury or death that must be weighed carefully against its purported benefits, especially by individuals, who may be at greater biological risk for suffering harm from using a particular drug or vaccine.

There is a misconception, one that is perpetuated by many pediatricians in the United States, that you need vaccines to stay well. No disease is caused by a “vaccine deficiency.” In fact, in my article featuring the top secrets of people who never get sick, vaccination is nowhere to be found.

Why?

Because, ultimately, it is the state of your immune system that determines whether or not you get sick when you’re exposed to an infectious disease.

The keys to boosting your immune system into a “lean, mean, disease-fighting machine” lie in your lifestyle habitshealthy food, stress relief, exercise, sleep, exposure to sunlight and so on. Artificially manipulating your immune system with a vaccine is not the same thing, nor does it produce the same desired disease-fighting and health-promoting result. I recommend that you not only get educated about vaccines, but also embrace these basic tenets of optimal health that will keep you well and disease-free, naturally.

  1. Eliminate sugar, especially fructose and most grains from your diet.
  2. Eat unprocessed, high-quality foods, organic if possible. If you haven’t reviewed my comprehensive free nutrition program, please do so when you have a moment.
  3. Get sufficient amounts of sun exposure on large areas of your skin to optimize your vitamin D levels (or alternatively use a safe tanning bed or vitamin D3 supplement).
  4. Consume enough high-quality animal-based omega-3 fats, such as krill oil.
  5. Exercise regularly, including high-intensity burst exercises like Peak Fitness.

What You Can Do to Make a Difference Right NOW

Protecting your right to informed consent is essential, for all the reasons discussed above and more. The National Vaccine Information Center (NVIC) has been the leading advocate for informed consent to vaccination since its inception. Signing up to be a user of NVIC’s free online Advocacy Portal at www.NVICAdvocacy.org gives you access to practical, useful information to help you become an effective vaccine choice advocate in your own community. The NVIC is 100 percent funded by donations, and during the month of April, all donations are automatically tripled. That’s right! For every $1 donated, a benefactor will match it with $2. So please, take a moment right now to make a donation to the NVIC.

nvic donate FDA: Vaccines more than other drugs most likely to be removed from the market due to safety issues

References:


iU.S. Food and Drug Administration Drug Recalls

 

Vaccine Epidemic
How Corporate Greed, Biased Science, and Coercive Government Threaten Our Human Rights, Our Health, and Our Children
by Louise Kuo Habakus and Mary Holland J.D.

Vaccine Epidemic bookcover FDA: Vaccines more than other drugs most likely to be removed from the market due to safety issues

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