Showing posts with label GlaxoSmithKline. Show all posts
Showing posts with label GlaxoSmithKline. Show all posts

Tuesday, December 10, 2013

FDA Pertussis Vaccine Study Shatters Illusion of Vaccine-Induced Immunity

Bordetella pertussis on Charcoal Agar - detail
Bordetella pertussis on Charcoal Agar - detail (Photo credit: Nathan Reading)
Recent vaccine research again reveals the gulf between what you’re told about vaccines—how they work and how effective they are at preventing infectious disease—versus what is truly known about naturally acquired and vaccine acquired immunity.
Nearly a century after the release of the whooping cough (B. pertussis) vaccine, mounting evidence suggests that widespread mandated use of the vaccine could potentially be doing more harm than good in the long term—in addition to having been found lacking in the effectiveness department. As reported by The Washington Post:1
“The research suggests that while the vaccine may keep people from getting sick, it doesn’t prevent them from spreading whooping cough — also known as pertussis — to others.
‘It could explain the increase in pertussis that we’re seeing in the US,’ said one of the researchers, Tod Merkel of the Food and Drug Administration...
Last year was the nation’s worst year for whooping cough in six decades— US health officials received reports of more than 48,000 cases, including 18 deaths... Some studies have concluded the newer vaccine doesn’t last as long as the old one. But the study by Merkel and his colleagues offers a new wrinkle.

New ‘Wrinkle’ Busts Major Hole in Pro-Mandatory Vaccination Argument

The “new wrinkle” revealed in the featured FDA baboon study is that while the vaccine can cut down on serious clinical disease symptoms, it doesn’t eliminatetransmission of the disease.2 This busts a major hole in the entire argument that vaccines achieve herd immunity, which is used as justification for mandatory vaccination campaigns.
According to the Washington Post:3
“'[I]t was thought that people only spread the disease when they had coughs and other symptoms,' said Dr. Erik Hewlett, a University of Virginia whooping cough researcher who was not involved in the FDA study but has collaborated with Merkel.
Health officials have sought to protect small children by vaccinating the people who are in contact with them such as grandparents and baby sitters— a strategy called ‘cocooning.’ But that may not work as well as hoped if infected people who don’t show any symptoms can still spread it, the research suggests. ‘This is a whole new way of thinking of the problem,’ Hewlett said.”

Whooping Cough Vaccination Makes You an ‘Asymptomatic Carrier

The study, titledAcellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model,”4 used infant baboons to test the hypothesis that "current acellular pertussis vaccines fail to prevent colonization and transmission" of B. pertussis.
The acellular pertussis vaccines that were licensed in 1996 for infants to replace reactive whole-cell pertussis vaccines contain lower levels of certain toxins (such as endotoxin) as well as purified antigens instead of all the components of whole killed B. pertussis bacteria.
The study concluded that infant baboons given Sanofi DTaP (Daptacel) vaccine at two, four, and six months of age were protected against developing outward clinical symptoms of pertussis after being exposed to B. pertussis at seven months of age, but they were still able colonize and transmit B. pertussis to other baboons.
The baboons that were vaccinated with whole cell pertussis (GlaxoSmithKline's Infanrix) also colonized B. pertussis upon exposure to B. pertussis, but they cleared the infection much faster than the acellular pertussis vaccinated baboons—in 18 days compared to 35 days.
Now, the researchers did not say that DTaP vaccine causes vaccine strain pertussis infection. B. pertussis vaccines (both whole cell DPT and acellular DTaP/Tdap) are inactivated vaccines and do not cause vaccine strain infection the way some attenuated live virus vaccines can—such as live oral polio (OPV) and varicella zoster (chickenpox) vaccines.
However, the lead author Tod Merkel did comment to the New York Times5 that when exposed to B. pertussis after recently getting vaccinated, you could be an asymptomatic carrier and infect others, saying:
“When you’re newly vaccinated, you are an asymptomatic carrier, which is good for you, but not for the population.”

Pertussis Vaccine May Not Curb Transmission of Illness

According to the researchers, acellular pertussis vaccine (Daptacel) induces high antibody titers, which is used to measure efficacy. Whole cell DPT (Infanrix) and natural B. pertussis infection also induce high antibody titers.
But, while acellular pertussis vaccinated baboons did not develop serious clinical disease symptoms—such as loss of appetite and cough—when they were directly challenged with B. pertussis (meaning exposed to the B. pertussis bacteria), they still colonized B. pertussis in their throats and were capable of transmitting the infection to other baboons.
Since acellular pertussis (DTaP) vaccines are the only type of pertussis vaccines now given to American children at the ages of two, four, six and 15-18 months, as well as between the ages of four and six years and at 11-12 years, the researchers said:
"These data suggest that cocooning is unlikely to be an effective strategy to reduce the burden of pertussis in infants. However, it is important to note that our data in combination with human data show that vaccination with acellular pertussis provides excellent protection from severe pertussis.
Therefore, any short-term plan for addressing the resurgence of pertussis should include continued efforts to enhance acellular pertussis immunization. However, to protect the most vulnerable members of the population and achieve optimal herd immunity, it will be necessary to develop a vaccination strategy that effectively blocks pertussis infection and transmission."

What You Need to Know About ‘Herd Immunity’

The issue of “herd immunity” as it pertains to vaccinations is a widely misunderstood subject. The National Institute of Allergy and Infectious Diseases describes vaccine-induced herd immunity (also labeled “community immunity” by public health doctors) as follows:6
“When a critical portion of a community is immunized against a contagious disease, most members of the community are protected against that disease because there is little opportunity for an outbreak. Even those who are not eligible for certain vaccines—such as infants, pregnant women, or immunocompromised individuals—get some protection because the spread of contagious disease is contained. This is known as ‘community immunity.’"
What many people don’t realize is that there is such a thing as natural herd immunity. The problem is that public health officialsassume that vaccines will work the same way. However, vaccines do not confer the same kind of immunity as experiencing and recovering from the natural disease.
The science clearly shows that there's a big difference between naturally acquired herd immunity and vaccine-acquired herd immunity, even as scientific knowledge about the biological mechanisms involved in naturally acquired and vaccine acquired immunity is incomplete. These facts are usually ignored because to openly acknowledge them opens the door to some very unwelcome questions about the overall effectiveness of mandatory vaccination programs.
Vaccines are designed to trick your body's immune system into producing an immune response that includes making protective antibodies that are needed to resist future exposure to the infectious viral or bacterial microorganism. However, your body is smarter than that. The artificial manipulation of your immune system by vaccines containing lab altered bacteria and viruses, as well as chemicals and other ingredients, simply does not exactly replicate the response that your immune system mounts when naturally encountering the infectious microorganism. This is one reason why vaccine policymakers say you need to get “booster” shots because vaccine acquired immunity is only temporary and wears off, sometimes rather quickly.
The featured study also provides evidence of this fact, showing that a vaccine-induced immune response differs from the immune response when naturally encountering the B. pertussis organism. The FDA researchers further suggested that there are also differences in immune responses to whole cell DPT vaccine, which contains the whole B. pertussis bacteria, and acellular pertussis vaccine, which contains lower levels of toxins and uses purified antigens. They said “Vaccination with wP [whole cell pertussis vaccine] and previous infection induced a more rapid clearance compared with naïve and aP[acelullar pertussis[-vaccinated animals.”
As reported by Medical Daily:7
“The researchers also found something revealing when they looked at the specific immune response of each group of monkeys. 'Although all vaccinated and previously infected animals had robust serum antibody responses, we found key differences in T-cell immunity,' the authors wrote in PNAS.
Specifically, previously infected animals and whole-cell-vaccinated animals both exhibited the same kind of boost in immune response while the acellular pertussis vaccination elicited a response that was slightly different. 'The observation that acellular pertussis, which induces an immune response mismatched to that induced by natural infection, fails to prevent colonization or transmission, provides a plausible explanation for the resurgence of pertussis...'"
Although the FDA researchers say they found differences between immune responses to the whole cell DPT vaccine acellular DTaP vaccine, they also admit that “neither vaccine was able to prevent colonization as well as immunity from a previous infection” and that “relative protection afforded by Th17 or Th1 responses in vaccinated or convalescent baboons or humans is not known.”
Bottom line: there are huge gaps in scientific knowledge about both B. pertussis vaccination and B. pertussis infections.

Which Is More Ideal—Permanent or Temporary Immunity?

To learn more, I urge you to listen to the following video, in which Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC), discusses the concept of herd immunity. In it, she brings up some very important questions that need to be seriously considered and answered through rigorous scientific investigation—investigation that has so far been largely ignored:
" In most cases natural exposure to disease would give you a longer lasting more robust qualitatively superior immunity because it gives you both cell mediated immunity and humoral immunity... The fact that manmade vaccines cannot replicate the body's natural experience with the disease is one of the key points of contention between those who insist that mankind cannot live without mass use of multiple vaccines and those who believe that mankind's biological integrity will be severely compromised by their continued use.
The fact that manmade vaccines cannot replicate the body's natural experience with the disease is one of the key points of contention between those who insist that mankind cannot live without mass use of multiple vaccines and those who believe that mankind's biological integrity will be severely compromised by their continued use.
... [I]s it better to protect children against infectious disease early in life through temporary immunity from a vaccine, or are they better off contracting certain contagious infections in childhood and attaining permanent immunity? Do vaccine complications ultimately cause more chronic illness and death than infectious diseases do? These questions essentially pit trust in human intervention against trust in nature and the natural order, which existed long before vaccines were created by man."

What We Don’t Understand Can Hurt Us

My main point of contention with those who insist that vaccines are the best answer for disease prevention, without regard for constitutional differences between people, is that the science is still grossly lacking when it comes to safety. We simply do not know if vaccination is an ideal choice for all people, all the time—even though that’s what public health officials and others promoting one-size-fits all mandatory vaccination policies would like you to believe. The evidence weighs rather heavily againstsuch a blanket position, in my opinion.
Take the recent news of healthy teenagers dying following flu vaccination for example. In January of this year, a 14-year old Carly Christenson passed away from complications from influenza type-A, despite being vaccinated against the flu.8


Most recently, healthy 19-year old Chandler Webb became violently ill the day after receiving a flu shot—the first flu shot he had ever received.9, 10 His symptoms included violent shaking, headache and vomiting. He was hospitalized with encephalitis (brain inflammation). As the swelling of his brain progressed, Chandler’s doctors frantically tested him for various infectious diseases and treated him with broad spectrum antibiotics. Apparently, they did not think to consider whether he’d been recently vaccinated. His brain became so inflamed that doctors told his mother the massive swelling crushed his brain stem. He died 28 days after his first and last dose of influenza vaccine.
Chandler’s mother wants to raise awareness about the potential of vaccines to cause serious complications like brain inflammation and is urging medical personnel to consider vaccine reactions when searching for potential causes and treating encephalitis and other possible vaccine-related health problems. In this case, the doctors are now claiming they were not able to confirm the cause of Chandler’s death, and are declining to comment because they say they are legally prohibited from making any statements about the case.11

Main Take-Home Points and Limitations of the Latest Pertussis Vaccine Study

To recap, FDA researchers conducting the featured baboon study found that the whole cell pertussis vaccine (GSK's Infanrix DPT), the acellular pertussis vaccine (Sanofi's Daptacel DTaP), and natural pertussis infection all induced high antibody titers in infant baboons. High antibody titer after vaccination is currently the gold standard for proving that a vaccine confers “immunity” and inability to colonize or transmit infection.

However in this study, high B. pertussis antibody titers after vaccination did NOT correlate with immunity and inability to colonize or transmit B. pertussis infection to other baboons—effectively challenging the idea that high antibody titer following vaccination is evidence that vaccination will prevent infection in the vaccine recipient and the recipient will not be able to infect others. Furthermore, the study authors found that:
  • Baboons vaccinated with a whole cell pertussis vaccine (DPT) colonized B. pertussis upon direct challenge but cleared infection almost twice as fast as animals vaccinated with an acellular pertussis vaccine (DTaP)—which is the type used by American children since 1996. This suggests that children recently given DTaP vaccine, who are exposed to B. pertussis may be astymptomatic carriers and transmitters of the infection for a longer period of time compared to children who get the older, more reactive whole cell DPT vaccine and clear infection more quickly.
  • Previous B. pertussis infection prevented colonization with B. pertussis in baboons better than having received either whole cell pertussis (Infanrix) or acelullar pertussis vaccine (Daptacel). In short, natural immunity offered greater protection against the ability to become infected and transmit infection after exposure to B. pertussis than either of the two vaccines.
That said, the researchers acknowledged the baboon study had limitations and among them were the fact that:
  • Baboons are not humans and the study authors admitted that "relative protection afforded by Th17 and Th1 responses in vaccinated or convalescent baboons or humans is not known."
  • Only one type of whole cell DPT and one type of acellular DTaP vaccine was used in this study but there are many different kinds of DPT and DTaP containing different components. Considering the known variability of measured efficacy and effectiveness of DPT and DTaP vaccines in clinical studies, the FDA study conclusions can only be limited to those two specific DPT and DTaP vaccines.

The Illusion of Vaccine-Acquired Immunity

The concept of vaccine induced herd immunity is built on the assumption that vaccination does protect the vast majority of vaccinated persons in a population from becoming infected with- and transmitting infection to others in the same way that naturally acquired immunity in a population protects acquisition and transmission of infection. The featured FDA research suggests this is not the case and offers a clue as to why whooping cough outbreaks have been occurring and spreading primarilywithin the vaccinated population. To quote NVIC’s Barbara Loe Fisher:
“In my opinion, this study in infant baboons suggests that pertussis vaccine-acquired immunity has been an illusion. Although the vaccines may protect against severe B. pertussis clinical symptoms of the disease—such as paroxysmal coughing—they do not prevent colonization of B. pertussis bacteria and transmission of the infection to others.
In this study at least, recovery from previous B. pertussis infection was more effective in preventing colonization with B.pertussis upon direct challenge than either whole cell DPT (Infanrix) or acellular DTaP (Daptacel) and that suggests transmission of the infection to others after exposure to B pertussis would also be less likely when there is a history of naturally acquired immunity.”

Protect Your Right to Informed Consent and Defend Vaccine Exemptions

With all the uncertainty surrounding the safety and efficacy of vaccines, it's critical to protect your right to make independent health choices and exercise voluntary informed consent to vaccination. It is urgent that everyone in America stand up and fight to protect and expand vaccine informed consent protections in state public health and employment laws. The best way to do this is to get personally involved with your state legislators and educating the leaders in your community.
THINK GLOBALLY, ACT LOCALLY.
National vaccine policy recommendations are made at the federal level but vaccine laws are made at the state level. It is at the state level where your action to protect your vaccine choice rights can have the greatest impact. It is critical for EVERYONE to get involved now in standing up for the legal right to make voluntary vaccine choices in America because those choices are being threatened by lobbyists representing drug companies, medical trade associations and public health officials, who are trying to persuade legislators to strip all vaccine exemptions from public health laws.
Signing up for NVIC's free Advocacy Portal at www.NVICAdvocacy.org gives you immediate, easy access to your own state legislators on your Smart Phone or computer so you can make your voice heard. You will be kept up-to-date on the latest state bills threatening your vaccine choice rights and get practical, useful information to help you become an effective vaccine choice advocate in your own community. Also, when national vaccine issues come up, you will have the up-to-date information and call to action items you need at your fingertips.
So please, as your first step, sign up for the NVIC Advocacy Portal.

Share Your Story with the Media and People You Know

If you or a family member has suffered a serious vaccine reaction, injury or death, please talk about it. If we don't share information and experiences with each other, everybody feels alone and afraid to speak up. Write a letter to the editor if you have a different perspective on a vaccine story that appears in your local newspaper. Make a call in to a radio talk show that is only presenting one side of the vaccine story.
I must be frank with you; you have to be brave because you might be strongly criticized for daring to talk about the "other side" of the vaccine story. Be prepared for it and have the courage to not back down. Only by sharing our perspective and what we know to be true about vaccination will the public conversation about vaccination open up so people are not afraid to talk about it.
We cannot allow the drug companies and medical trade associations funded by drug companies or public health officials promoting forced use of a growing list of vaccines to dominate the conversation about vaccination. The vaccine injured cannot be swept under the carpet and treated like nothing more than "statistically acceptable collateral damage" of national one-size-fits-all mandatory vaccination policies that put way too many people at risk for injury and death. We shouldn't be treating people like guinea pigs instead of human beings.

Internet Resources Where You Can Learn More

I encourage you to visit the website of the non-profit charity, the National Vaccine Information Center (NVIC), at www.NVIC.org:
  • NVIC Memorial for Vaccine Victims: View descriptions and photos of children and adults, who have suffered vaccine reactions, injuries and deaths. If you or your child experiences an adverse vaccine event, please consider posting and sharing your story here.
  • If You Vaccinate, Ask 8 Questions: Learn how to recognize vaccine reaction symptoms and prevent vaccine injuries.
  • Vaccine Freedom Wall: View or post descriptions of harassment and sanctions by doctors, employers, school and health officials for making independent vaccine choices.

Connect with Your Doctor or Find a New One That Will Listen and Care

If your pediatrician or doctor refuses to provide medical care to you or your child unless you agree to get vaccines you don't want, I strongly encourage you to have the courage to find another doctor. Harassment, intimidation, and refusal of medical care is becoming the modus operandi of the medical establishment in an effort to stop the change in attitude of many parents about vaccinations after they become truly educated about health and vaccination.
However, there is hope.
At least 15 percent of young doctors recently polled admit that they're starting to adopt a more individualized approach to vaccinations in direct response to the vaccine safety concerns of parents. It is good news that there is a growing number of smart young doctors who prefer to work as partners with parents in making personalized vaccine decisions for children, including delaying vaccinations or giving children fewer vaccines on the same day or continuing to provide medical care for those families who decline use of one or more vaccines.
So take the time to locate a doctor who treats you with compassion and respect, and is willing to work with you to do what is right for your child.
Enhanced by Zemanta

Thursday, October 17, 2013

Organized Crime Ring The Pharmaceutical Drug Cartel

English: Example of promotional "freebies...
English: Example of promotional "freebies" given to physicians by pharmaceutical companies (Photo credit: Wikipedia)




By Dr. Mercola
Even though the video above is a few years old now and bigger fines of $3 billion have been assessed to GlaxoSmithKline two years ago, it is a good summary of how the drug cartels operate.
Did you know that nearly 20 percent of corporate crime is being committed by companies that make products for your health?
Sad but true, no less than 19 pharmaceutical companies made AllBusiness.com's Top 100 Corporate Criminals List for the 1990s, and the trend has continued if not increased into the 21st Century. Crimes committed by some of the most well-known drug companies include:
  • Fabricated studies
  • Covering up serious problems with their drugs
  • False claims
  • Bribery, illegal kick-backs, and defrauding Medicare, Medicaid, and even the FDA
  • Immoral threat and intimidation tactics (recall the international drug company Merck actually had a hit list of doctors to be "neutralized" or discredited for criticizing the lethally dangerous painkiller Vioxx. "We may need to seek them out and destroy them where they live," a Merck employee wrote, according to an email excerpt read in court.)

Pulling Back the Curtain on Organized Crime

Fortunately, organizations like the Bureau of Investigative Journalism,1 the False Claims Act Legal Center,2 and Politicol News3 have all started investigating and publicizing the criminal actions these companies have been getting away with for decades.
Most recently, the British Medical Journal’s blog featured an article4 by former BMJ editor and director of the United Health Group’s chronic disease initiative, Richard Smith, aptly titled: "Is the Pharmaceutical Industry Like the Mafia?"
The piece is also the foreword to the book, Deadly Medicines and Organized Crime: How Big Pharma Has Corrupted Healthcare, written by Peter Gøtzsche, head of the Nordic Cochrane Centre, which is considered the gold standard in terms of independent research reviews.
In related news, a recently published study concluded that most drug commercials are misleading or outright false.5 There’s a literal mountain of evidence proving that pharmaceutical companies are untrustworthy at best, and criminal at worst. And yet they’re the backbone of our modern “healthcare” system...
Even Forbes Magazine6 recently published an article with the provocative headline: "Is Big Pharma Addicted To Fraud?" and asked out loud “whether any aspect of the pharmaceutical business can be trusted.”

Is It Fair to Compare the Pharmaceutical Industry with the Mafia?

If you depend on conventional medical care to address your health problems, then you’re basically entrusting your health to organizations that clearly have far more interest in their bottom line than your health. In his article, Is the Pharmaceutical Industry Like the Mafia? Smith writes:7
“The characteristics of organized crime, racketeering, is defined in US law as the act of engaging repeatedly in certain types of offence, including extortion, fraud, federal drug offenses, bribery, embezzlement, obstruction of justice, obstruction of law enforcement, tampering with witnesses, and political corruption.

Peter [Gøtzsche] produces evidence, most of it detailed, to support his case that pharmaceutical companies are guilty of most of these offenses.
And he is not the first to compare the industry with the Mafia or mob. He quotes a former vice-president of Pfizer, who has said:
‘It is scary how many similarities there are between this industry and the mob. The mob makes obscene amounts of money, as does this industry. The side effects of organized crime are killings and deaths, and the side effects are the same in this industry. The mob bribes politicians and others, and so does the drug industry…’
Smith also notes that many more people are killed by the pharmaceutical industry than the mob. Prescription drugs also kill far more people than illegal drugs, and while most major causes of preventable deaths are declining, those from prescription drug use are on the incline.8, 9
For example, prescription drug fatalities more than doubled among teens and young adults between 2000 and 2008, and more than tripled among people aged 50 to 69.
Legal prescription drug abuse is a silent epidemic, and is part of the reason why the modern American medical system has become one of the leading causes of death and injury in the United States.

An estimated 450,000 preventable medication-related adverse events occur in the US every year. Merck’s painkiller Vioxx alone killed more than 60,000 people within a few years’ time before being withdrawn from the market.
“... [T]he benefits of drugs are exaggerated, often because of serious distortions of the evidence behind the drugs, a ‘crime’ that can be attributed confidently to the industry,” Smith writes.“The great doctor William Osler famously said that it would be good for humankind and bad for the fishes if all the drugs were thrown into the sea.
He was speaking before the therapeutic revolution in the middle of the 20th century that led to penicillin, other antibiotics, and many other effective drugs, but Peter comes close to agreeing with him and does speculate that we would be better off without most psychoactive drugs, where the benefits are small, the harms considerable, and the level of prescribing massive.”

'Science-Based' Medicine Has Fallen on Its Own Sword

There are many areas within which corruption can take root, and the drug industry has nurtured corruption in most if not all of them. It would require an entire book to begin to address them all, which is exactly what Peter Gøtzsche has done in his book, Deadly Medicines and Organized Crime: How Big Pharma Has Corrupted Healthcare.
One of the most dangerous forms of corruption is that which occurs within medical science. For example, according to data from Thomson Reuters,10 the number of retractions of scientific studies have increased more than 15-fold since 2001, and a review11 published just last year showed that nearly 75 percent of all retracted drug studies were attributed to “scientific misconduct,” which includes:
  • Data falsification or fabrication
  • Questionable veracity
  • Unethical author conduct
  • Plagiarism
Corruption of science is incredibly serious, as health care professionals rely on published studies to make treatment recommendations, and large numbers of patients can be harmed when false findings are published. The average lag time between publication of the study and the issuing of a retraction is 39 months. And that's if the misconduct is ever caught at all. What’s worse, about 32 percent of retractions are never published,12 leaving the readers completely in the dark about the inaccuracies in those studies!

Poster Children for Corrupted Science

One clear example of how deadly corrupted science can be is the painkiller Vioxx. There were many indications that this would be a dangerous drug, despite Merck’s claims, and I warned my readers to avoid it before its FDA approval in 1999. In 2008, four years after the drug was withdrawn from the market, an editorial13 published in the Journal of the American Medical Association(JAMA) suggested Merck might have deliberately manipulated dozens of academic documents published in the medical literature, in order to promote Vioxx under false pretenses.
The diabetes drug Avandia is another potent example. Between 1999 and 2007, Avandia is estimated to have caused over 80,000 unnecessary heart attacks,14 although the actual numbers of people harmed or killed by the drug is still largely unknown. Avandia is a poster child for the lethal paradigm of corrupted science as GlaxoSmithKline (GSK), the manufacturer of Avandia,hid damaging information about the drug for over 10 years, as they knew it would adversely affect sales!
Two years ago, GSK agreed to a $3 billion settlement over the sales and marketing practices of several of its drugs, including Avandia. This was the largest federal drug-company settlement in US history, surpassing the $2.3 billion paid by Pfizer in 2009(see video above) for illegally promoting off-label uses of four of its drugs. Most recently, GSK’s crooked ways made international headlines yet again when Chinese authorities arrested four of the company’s senior executives on charges of cash and sexual bribery. Another 18 GSK employees and medical personnel were also reportedly detained.15 As reported by The Guardian:16
“The Chinese authorities have accused GSK of acting like a criminal "godfather", using a network of 700 middlemen and travel agencies to bribe doctors with £320m [$489 million] cash and sexual favors in return for prescribing GSK drugs. Gao said the police have evidence that bribery has been a 'core part' of GSK China's business model since 2007.” [Emphasis mine]
As Smith writes in the featured article:
“The drug industry has systematically corrupted science to play up the benefits and play down the harms of their drugs... the industry has bought doctors, academics, journals, professional and patient organizations, university departments, journalists, regulators, and politicians. These are the methods of the mob.
The book doesn’t let doctors and academics avoid blame... doctors and academics are supposed to have a higher calling. Laws that are requiring companies to declare payments to doctors are showing that very high proportions of doctors are beholden to the drug industry and that many are being paid six figures sums for advising companies or giving talks on their behalf. It’s hard to escape the conclusion that these ‘key opinion leaders’ are being bought. They are the ‘hired guns’ of the industry.
And, as with the mob, woe be to anybody who whistleblows or gives evidence against the industry. Peter tells several stories of whistleblowers being hounded, and John Le Carré’s novel describing drug company ruthlessness became a bestseller and a successful Hollywood film.”

New Study Finds Most Drug Commercials Misleading

In related news, a recent study17 concluded that a majority of American drug commercials—60 percent of prescription drug ads, and 80 percent of ads for over-the-counter (OTC) drugs—are either misleading or outright false. Lead author Adrienne E. Faerber told Scientific American:18
“There were cases of blatant lying, but these half-truths form more than half of our analysis.”
In all, the researchers analyzed 84 prescription and 84 OTC drug ads aired on major networks between 2008 and 2010. Ads deemed to be “potentially misleading” omitted important information, exaggerated information, made lifestyle associations, or expressed opinions. Ads making false claims were either factually false or unsubstantiated. Ads promoting erectile dysfunction drugs were among the worst offenders. OTC drugs, which are overseen by the Federal Trade Commission and not the FDA, were also more likely to be misleading or false. Overall, a mere 33 percent of drug ads were found to be “objectively true.”
Interestingly enough, other research published in the journal Psychological Science19, 20 found that warnings of adverse side effects in drug ads can actually backfire over time. While initially making viewers cautious, over the course of time people tend to ignore the warnings. People even began to see the warning as "an indication of the firm's honesty and trustworthiness!" According to the authors:
“In four studies, we demonstrated this phenomenon. For example, participants could buy cigarettes or artificial sweeteners after viewing an ad promoting the product. Immediately afterward, the quantity that participants bought predictably decreased if the ad they saw included a warning about adverse side effects. With temporal distance (product to be delivered 3 months later, or 2 weeks after the ad was viewed), however, participants who had seen an ad noting the benefits of the product but warning of risky side effects bought more than those who had seen an ad noting only benefits.”

But Who Is Behind the Drug Companies?

While it is true that there were fines of $2 billion and $3 billion against the drug companies, that really pales in comparison to the fines being leveraged against the financial industry. JP Morgan will likely receive an $11 billion dollar fine.21 This level of fine doesn’t even begin to come close to what these criminal institutions really deserve for how they have ruined the US economy.
But keeping the article focused on health, you have to wonder if there is some common thread here and I believe there is.  The drug companies are typically owned by other corporations. Just as the featured video shows, the shell game that Pfizer played shielded them by developing tiered lower-level corporations. What is rarely ever explained is that the corporate shield also runs in the other direction. The primary owners of most of these drug companies are the international banksters that are responsible for most of the problems we see not only in the health arena, but in all areas of the world.

How To Avoid Becoming a Disease Statistic

Ultimately, the take-home message here is that even if a drug or treatment is "backed by science," this in no way guarantees it is safe or effective. Likewise, if an alternative treatment has not been published in a medical journal, it does not mean it is unsafe or ineffective. Also, when a drug or treatment does come with warnings, do yourself a favor and don’t tuck that information into some recessed corner in the back of your mind!
You've got to use all the resources available to you, including your own sense of common sense and reason, true experts' advice and other's experiences, to determine what medical treatment or advice will be best for you in any given situation. I advise you to remain skeptical but open -- even if it is something I'm saying, you need to realize that YOU are responsible for your and your family's health, not me, and certainly not drug companies trying to sell their wares and convince you to take dangerous "symptom-cover-ups" disguised as science-based solutions.
When it comes to health, an ounce of prevention is certainly better than a pound of cure, especially when the cure comes in a pill. Please keep in mind that leading a common-sense, healthy lifestyle is your best bet to achieve and maintain a healthy body and mind. And while conventional medical science may flip-flop back and forth in its recommendations, there are certain basic tenets of optimal health (and healthy weight) that do not change, including the following:
  1. Proper Food Choices: For a comprehensive guide on which foods to eat and which to avoid, see my nutrition plan. Generally speaking, you should be looking to focus your diet on whole, ideally organic, unprocessed foods. For the best nutrition and health benefits, you will want to eat a good portion of your food raw.
  2. Avoid sugar, and fructose in particular. All forms of sugar have toxic effects when consumed in excess, and drive multiple disease processes in your body, not the least of which is insulin resistance, a major cause of chronic disease and accelerated aging. I believe the two primary keys for successful weight management are severely restricting carbohydrates (sugars, fructose, and grains) in your diet, and increasing healthy fat consumption. This will optimize insulin and leptin levels, which is key for maintaining a healthy weight and optimal health.
  3. Regular exercise: Even if you're eating the healthiest diet in the world, you still need to exercise to reach the highest levels of health, and you need to be exercising effectively, which means including high-intensity activities into your rotation. High-intensity interval-type training boosts human growth hormone (HGH) production, which is essential for optimal health, strength and vigor. HGH also helps boost weight loss. So along with core-strengthening exercises, strength training, and stretching, I highly recommend that twice a week you do Peak Fitness exercises, which raise your heart rate up to your anaerobic threshold for 20 to 30 seconds, followed by a 90-second recovery period.
  4. Stress Reduction: You cannot be optimally healthy if you avoid addressing the emotional component of your health and longevity, as your emotional state plays a role in nearly every physical disease -- from heart disease and depression, to arthritis and cancer. Meditation, prayer, social support and exercise are all viable options that can help you maintain emotional and mental equilibrium. I also strongly believe in using simple tools such as the Emotional Freedom Technique (EFT) to address deeper, oftentimes hidden, emotional problems.
  5. Drink plenty of clean water.
  6. Maintain a healthy gut: About 80 percent of your immune system resides in your gut, and research is stacking up showing that probiotics—beneficial bacteria—affect your health in a myriad of ways; it can even influence your ability to lose weight. A healthy diet is the ideal way to maintain a healthy gut, and regularly consuming traditionally fermented foods is the easiest, most cost effective way to ensure optimal gut flora.
  7. Optimize your vitamin D levels: Research has shown that increasing your vitamin D levels can reduce your risk of death from ALL causes. For practical guidelines on how to use natural sun exposure to optimize your vitamin D benefits, please see my previous article on how to determine if enough UVB is able to penetrate the atmosphere to allow for vitamin D production in your skin.
  8. Avoid as many chemicals, toxins, and pollutants as possible: This includes tossing out your toxic household cleaners, soaps, personal hygiene products, air fresheners, bug sprays, lawn pesticides, and insecticides, just to name a few, and replacing them with non-toxic alternatives.
  9. Get plenty of high quality sleep: Regularly catching only a few hours of sleep can hinder metabolism and hormone production in a way that is similar to the effects of aging and the early stages of diabetes. Chronic sleep loss may speed the onset or increase the severity of age-related conditions such as type 2 diabetes, high blood pressure, obesity, and memory loss.
Enhanced by Zemanta

Thursday, October 3, 2013

Violent Side Effects of Antidepressants

On the Threshold of Eternity
On the Threshold of Eternity (Photo credit: Wikipedia)
In light of a long list of mass shootings over the past several years, the causative role of psychiatric drugs in violent events will undoubtedly have to be evaluated and addressed at some point. Personally, I’d vote for sooner, rather than later.
Antidepressants in particular have a well-established history of causing violent side effects, including suicide and homicide.  In a recent Scientific American1article, the author states:
“Once again, antidepressants have been linked to an episode of horrific violence. The New York Times2 reports that Aaron Alexis, who allegedly shot 12 people to death at a Navy facility in Washington, DC, earlier this week, received a prescription for the antidepressant trazodone3 in August.”
The drug in question, trazodone, has been associated with:4
“New or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement.”
The naval yard shooting is just the latest event to bring questions about prescription medications to the fore, but it bears noting that in this particular case no evidence has yet been released confirming that the shooter had the drug in his system at the time of the massacre.
Still, questions about the safety, or lack thereof, of antidepressants and other psychiatric drugs really need to be addressed regardless of whether they were instrumental in this particular case. Just last year, a Canadian judge ruled that a teenage boy murdered his friend because of the effects of Prozac.
When will such side effects be taken seriously? Just how many people have to kill themselves or others before a drug is considered too dangerous to be prescribed?
In a paper titled Antidepressants and Violence: Problems at the Interface of Medicine and Law,5 David Healy, a British professor of psychiatry at Cardiff University and an authority on side effects of psychiatric drugs, writes:
 “Legal systems are likely to continue to be faced with cases of violence associated with the use of psychotropic drugs, and it may fall to the courts to demand access to currently unavailable data. The problem is international and calls for an international response.”

Potential Side Effects of Antidepressants = Violence and Worsened Depression

In 2004, the US Food and Drug Administration (FDA) revised6 the labeling requirements for antidepressant medications (SSRI’s and others), warning that:
“Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.
Anyone considering the use of [Insert established name] or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.”
These labeling revisions were in large part driven by lawsuits, in which pharmaceutical companies were forced to reveal previously undisclosed drug data.

For example, a civil lawsuit filed in 20047 charged GlaxoSmithKline (GSK) with fraud, claiming the drug manufacturer hid results from studies on Paxil showing the drug did not work in adolescents and in some cases led to suicidal ideation. Rather than warning doctors of such potential side effects, GSK actually encouraged them to prescribe the drug to teens and children.
According to DrugWatch.com,8 GSK has agreed to pay out more than $1 billion to settle more than 800 different lawsuits related to Paxil—and that’s over and above the $3 billion it agreed to pay to settle the Department of Justice’s investigation into illegal marketing of Paxil and other drugs!
In an effort to gather the necessary data on adverse side effects, Healy and other healthcare experts have formed an organization called RxISK.9 It’s a free, independent website where patients, doctors, and pharmacists can report side effects and research prescription drugs of all kinds. I’d encourage you to bookmark it and refer to it when needed.

Antidepressants and ADHD Drugs Top List of Most Violence-Inducing Drugs

Please note that antidepressants are not the only type of drugs associated with violent, homicidal behavior, but they are among the most common suspects. A study10 by the Institute of Safe Medication Practices published in 2010 identified no less than 31 commonly-prescribed drugs that are disproportionately associated with cases of violent acts. Topping the list is the quit-smoking drug Chantix, followed by Prozac and Paxil, and drugs used to treat ADHD.
The data was collected from the FDA's Adverse Event Reporting System (VAERS), and it's well worth noting here that only an estimated one to 10 percent of all side effects are ever reported to VAERS, so the fact that more than 1,500 violent acts were actually reported as being linked to any given drug is pretty amazing. The vast majority of side effects, regardless of what they are, are typically blamed on something else and connections are brushed aside as "coincidental."
In all, five of the top 10 most violence-inducing drugs were found to be antidepressants:
  • Fluoxetine (Prozac)
  • Paroxetine (Paxil)
  • Fluvoxamine (Luvox)
  • Venlafaxine (Effexor)
  • Desvenlafaxine (Pristiq)
According to Professor Healy, a study by the Drug Safety Research Unit in Southampton showed that one in every 250 subjects taking Paxil or Prozac were involved in a violent episode. In a study group of 25,000 people, this included 31 assaults and one homicide. In 2011, a whopping 14 million prescriptions for Paxil and more than 25.5 million prescriptions for Prozac were written.11 This could potentially equate to some 158,000 drug-induced incidents of violence annually from these two drugs alone. As reported in the featured article:12
“Another study involving more than 9,000 subjects taking the antidepressant paroxetine (Paxil) for depression and other disorders showed that subjects experienced more than twice as many ‘hostility events’ as subjects taking a placebo.” ... Healy suspects that the main causal factor behind suicide and violence toward others is increased mental and/or physical agitation, which leads about five percent of subjects taking antidepressants to drop out of clinical trials, compared to only 0.5 percent of people on placebos.”
Another two in that top 10 list of violence-promoting drugs are commonly-prescribed ADHD medications (including Strattera). When you consider that antidepressants and ADHD drugs are among the most prescribed types of drugs13 in the US, the fact that so many of them are linked to increased rates of violence should be cause for pause. Besides an increased risk of violent episodes, ADHD drugs such as Ritalin, Vyvanse, Strattera, and Adderall (and their generic equivalents) are also responsible for nearly 23,000 emergency room visits annually, as of 2011 statistics. Over a mere six-year span, there’s been a 400 percent increase in ER visits due to side effects of these drugs.

Use Antipsychotic Medications with More Care, Psychiatrists Say

In related news,14 the American Psychiatric Association (APA) recently issued a statement urging doctors and patients to reconsider the practice of using anti-psychotic medications as the first line of treatment for:
  • Dementia in the elderly
  • Behavior problems in children, or
  • Insomnia in adults
The drugs in question include Risperdal, Zyprexa, Seroquel, and Abilify. APA’s recommendation with regards to anti-psychotic drug prescriptions is part of a larger campaign called Choosing Wisely,15 which covers a wide array of common medical practices that patients and doctors would do well to question, as they may cause more harm than good. Joel Yager, a psychiatry professor at the University of Colorado-Boulder, told USA Today:
“Doctors who overprescribe the medications are doing what they think might help, often without first trying safer or more effective alternatives.”

Key Factors to Overcoming Depression Without Drugs

It’s important to realize that your diet and general lifestyle are foundational factors that must be opitimized if you want to resolve your mental health issues, because your body and mind are so closely interrelated. Depression is indeed a very serious condition; however, it is not a “disease.” Rather, it’s a sign that your body and your life are out of balance.
Mounting and compelling research demonstrates just how interconnected your mental health is with your gastrointestinal health, for example. While many think of their brain as the organ in charge of their mental health, your gut may actually play a far more significant role. The drug treatments available today for depression are no better than they were 50 years ago. Clearly, we need a new approach, and diet is an obvious place to start.
Research tells us that the composition of your gut flora not only affects your physical health, but also has a significant impact on your brain function and mental state. Previous research has also shown that certain probiotics can even help alleviate anxiety16,17. The place to start is to return balance—to your body and your life. Fortunately, research confirms that there are safe and effective ways to address depression that do not involve unsafe drugs. These include:
  • Dramatically decrease your consumption of sugar (particularly fructose), grains, and processed foods. (In addition to being high in sugar and grains, processed foods also contain a variety of additives that can affect your brain function and mental state, especially MSG, and artificial sweeteners such as aspartame.)  There's a great book on this subject, The Sugar Blues, written by William Dufty more than 30 years ago, that delves into the topic of sugar and mental health in great detail.
  • Increase consumption of probiotic foods, such as fermented vegetables and kefir, to promote healthy gut flora. Mounting evidence tells us that having a healthy gut is profoundly important for both physical and mental health, and the latter can be severely impacted by an imbalance of intestinal bacteria.
  • Get adequate vitamin B12. Vitamin B12 deficiency can contribute to depression and affects one in four people.
  • Optimize your vitamin D levels, ideally through regular sun exposure. Vitamin D is very important for your mood. In one study, people with the lowest levels of vitamin D were found to be 11 times more prone to be depressed than those who had normal levels.18

    The best way to get vitamin D is through exposure to SUNSHINE, not swallowing a tablet. Remember, SAD (Seasonal Affective Disorder) is a type of depression that we know is related to sunshine deficiency, so it would make sense that the perfect way to optimize your vitamin D is through sun exposure, or a safe tanning bed if you don't have regular access to the sun.
  • Get plenty of animal-based omega-3 fats. Many people don't realize that their brain is 60 percent fat, but not just any fat. It is DHA, an animal based omega-3 fat which, along with EPA, is crucial for good brain function and mental health.19Unfortunately, most people don't get enough from diet alone. Make sure you take a high-quality omega-3 fat, such as krill oil.

    Dr. Stoll, a Harvard psychiatrist, was one of the early leaders in compiling the evidence supporting the use of animal based omega-3 fats for the treatment of depression. He wrote an excellent book that details his experience in this area called The Omega-3 Connection.
  • Evaluate your salt intake. Sodium deficiency actually creates symptoms that are very much like those of depression. Make sure you do NOT use processed salt (regular table salt), however. You'll want to use an all-natural, unprocessed salt like Himalayan salt, which contains more than 80 different micronutrients.
  • Get adequate daily exercise, which is one of the most effective strategies for preventing and overcoming depression. Studies on exercise as a treatment for depression have shown there is a strong correlation between improved mood and aerobic capacity. So there’s a growing acceptance that the mind-body connection is very real, and that maintaining good physical health can significantly lower your risk of developing depression in the first place.
  • Get adequate amounts of sleep. You can have the best diet and exercise program possible, but if you aren't sleeping well you can easily become depressed. Sleep and depression are so intimately linked that a sleep disorder is actually part of the definition of the symptom complex that gives the label depression.

What the Future May Hold

A recent article in The Guardian20 suggests psychiatric drugs may soon be rendered obsolete, in favor of neurotechnology. “No longer focused on developing pills, a huge research effort is now devoted to altering the function of specific neural circuits by physical intervention in the brain,” Vaughan Bell writes, noting that virtually all pharmaceutical companies have closed down or curtailed their research and development of new psychiatric drugs.
The latest “craze” in this field has instead been redirected toward the understanding—and manipulation—of neural networks, with the aim to modify behavior by stimulating specific brain circuits deep within your brain. Some of these procedures include the implanting of electrodes into the brain, for example. According to the article:
“Big money has already been committed. The Obama White House has promised $3 billion to develop technology to help identify brain circuits, while the National Institute of Mental Health has promised to move its seven-figure funding away from research into conditions such as schizophrenia and depression towards a system that looks at how brain networks contribute to difficulties that are shared across diagnoses. This project, given the unspectacular name Research Domain Criteria or the RdoC Project, is being cited as an eventual replacement for the diagnostic system used by current-day psychiatrists.”
One of the latest technologies in this area, called optogenetics, involves “injecting neurons with a benign virus that contains the genetic information for light-sensitive proteins.” As a result of this injection, your brain cells become light-sensitive, allowing them to be remotely controlled via flashes of light sent through fiber optic cables implanted into your brain.
“Let's make this clear. The scientific revolution in identifying and manipulating brain circuits is already under way,”Vaughan writes. “... Advances in neuroscience are not just discoveries, they also shape, as they always have done, how we view ourselves. As the Prozac nation fades, the empire of the circuit-based human will rise...”
Whether or not this will actually make for happier, healthier, more balanced people is questionable, if you ask me. Yet this is what we may have to contend with in the future.

The Benefits of Energy Psychology

The Emotional Freedom Technique (EFT) is a form of psychological acupressure based on the same energy meridians used in traditional acupuncture to treat physical and emotional ailments for over 5,000 years, but without the invasiveness of needles. Instead, simple tapping with the fingertips is used to transfer kinetic energy onto specific meridians on your head and chest while you think about your specific problem -- whether it is a traumatic event, an addiction, pain, anxiety, etc. -- and voice positive affirmations.
This combination of tapping the energy meridians and voicing positive affirmation works to clear the "short-circuit"—the emotional block—from your body's bioenergy system, thus restoring your mind and body's balance, which is essential for optimal health and the healing of physical disease.
Some people are initially wary of these principles that EFT is based on -- the electromagnetic energy that flows through the body and regulates our health is only recently becoming recognized in the West. Others are initially taken aback by (and sometimes amused by) the EFT tapping and affirmation methodology. But believe me when I say that, more than any traditional or alternative method I have used or researched, EFT has the most potential to literally work magic.
Clinical trials have shown that EFT is able to rapidly reduce the emotional impact of memories and incidents that trigger emotional distress. Once the distress is reduced or removed, the body can often rebalance itself, and accelerate healing. For example, one study involving 30 moderately to severely depressed college students showed significantly less depression than the control group when evaluated three weeks after receiving a total of four 90-minute EFT sessions.21
A study of 100 veterans with severe PTSD22 who participated in the Iraq Vets Stress Project showed an astounding reduction of symptoms after just six one-hour EFT sessions. After completing six sessions, 90 percent of the veterans had such a reduction in symptoms that they no longer met the clinical criteria for PTSD. Sixty percent no longer met PTSD criteria after only three EFT sessions. At the three-month follow-up, the gains remained stable, suggesting lasting and potentially permanent resolution of the problem.
In the following videos, EFT practitioner Julie Schiffman shows how you can use EFT to relieve your depression, anxiety, and panic attacks. But remember, most of the time one is placed on medication, there are serious emotional health challenges going on. It is imperative to recognize that doing EFT by yourself will likely not work for this problem. You need to be seen by an EFT professional who is experienced and can help guide you through the process Those who suffer from depression really should see a qualified EFT therapist.23

 Important Concluding Thoughts
I know firsthand that depression is devastating. It takes a toll on the healthiest of families and can destroy lifelong friendships. Few things are harder in life than watching someone you love lose their sense of joy, hope, and purpose in life, and wonder if they will ever find it again. And to not have anything within your power that can change things for them. You wonder if you will ever have your loved one "back" again.
It's impossible to impart the will to live to somebody who no longer possesses it. No amount of logic, reasoning, or reminders about all they have to live for will put a smile back on the face of a loved one masked by the black cloud of depression. I urge everyone to familiarize yourself with the most common warning signs of severe depression and suicide risk, and don’t hesitate to intervene if you recognize them in someone you know, and/or seek help if you experience them yourself.
There are times when a prescription drug may be helpful. But it's unclear whether it is the drug providing benefits, or the unbelievable power of your mind that is convinced it is going to work. Studies have found that up to 75 percent of the benefits ofantidepressants can be duplicated by a placebo.
Oftentimes you cannot change your circumstances. You can, however, change your response to them. I encourage you to be balanced in your life. Don't ignore your body's warning signs that something needs to change. Sometimes people are so busy taking care of everybody else that they lose sight of themselves. If you have been personally affected by depression, my heart goes out to you. A broken body can be easier to fix than a broken mind. Depression is real. It is my hope that you don't feel judged here, but that you are encouraged and inspired by those who have been there.
Enhanced by Zemanta