Sunday, September 14, 2014

Inflammation in the guts and depression

Can Inflammation in Your Gut Be the Root of Your Depression?

October 06, 2011 | 152,564 views
Recent studies have shown that inflammation may be involved in the pathogenesis of depression. In fact, some research has demonstrated that depression is frequently associated with gastrointestinal inflammations and autoimmune diseases as well as with other ailments in which chronic low-grade inflammation is a significant contributing factor.
It is possible that depression could be a neuropsychiatric manifestation of a chronic inflammatory syndrome. And the primary cause of inflammation may be the dysfunction of the "gut-brain axis".
According to a study reprinted on the website Green Med Info:
"... [A]n increasing number of clinical studies have shown that treating gastrointestinal inflammations with probiotics, vitamin B, D and omega 3 fatty acids, through attenuating proinflammatory stimuli to brain, may also improve depression symptoms and quality of life. All these findings justify an assumption that treating gastrointestinal inflammations may improve the efficacy of the currently used treatment modalities of depression and related diseases."
By Dr. Mercola
The notion that inflammation in your gut could be linked to your symptoms of depression may sound far-fetched, but it actually makes perfect sense when you understand the intricate connection between your brain and your digestive tract.
Perhaps the simplest example to use is getting butterflies in your stomach when you're nervous, thus your thoughts, i.e. brain, are manifesting symptoms in your gut. But another route of connection is via low-grade inflammation, which is a significant contributing factor to numerous diseases that often occur alongside depression, and may, in fact, be manifesting your depressive symptoms.

Is Depression the Result of Chronic Inflammation?

A recent review has pointed out several mechanisms by which gastrointestinal inflammation may play a critical role in the development of depression.
Among them:
  1. Depression is often found alongside gastrointestinal inflammations and autoimmune diseases as well as with cardiovascular diseases, neurodegenerative diseases, type 2-diabetes and also cancer, in which chronic low-grade inflammation is a significant contributing factor. Thus researchers suggested "depression may be a neuropsychiatric manifestation of a chronic inflammatory syndrome."
  2. Research suggests the primary cause of inflammation may be dysfunction of the "gut-brain axis." Your gut is literally your second brain -- created from the identical tissue as your brain during gestation -- and contains larger amounts of the neurotransmitter serotonin, which is associated with mood control.
  3. It's important to understand that your gut bacteria are an active and integrated part of your body, and as such are heavily dependent on your diet and vulnerable to your lifestyle. If you consume a lot of processed foods and sweetened drinks, for instance, your gut bacteria are likely going to be severely compromised because processed foods in general will destroy healthy microflora and sugars of all kinds feed bad bacteria and yeast, as well as promote systemic inflammation.
  4. An increasing number of clinical studies have shown that treating gastrointestinal inflammation with probiotics, vitamin B, vitamin D and omega-3 fats may also improve depression symptoms and quality of life by attenuating proinflammatory stimuli to your brain.
What this all boils down to is that chronic inflammation in your body disrupts the normal functioning of many bodily systems, and can wreak havoc on your brain. But it appears inflammation may be more than just another risk factor for depression; it may in fact be THE risk factor that underlies all others. Although this refers to postpartum depression, the inflammatory response is the same in its impact on all forms of depression.
Published in the International Breastfeeding Journal, researchers stated:
"The old paradigm described inflammation as simply one of many risk factors for depression. The new paradigm is based on more recent research that has indicated that physical and psychological stressors increase inflammation. These recent studies constitute an important shift in the depression paradigm: inflammation is not simply a risk factor; it is the risk factor that underlies all the others.
Moreover, inflammation explains why psychosocial, behavioral and physical risk factors increase the risk of depression. This is true for depression in general and for postpartum depression in particular.
Puerperal women are especially vulnerable to these effects because their levels of proinflammatory cytokines significantly increase during the last trimester of pregnancy -- a time when they are also at high risk for depression.Moreover, common experiences of new motherhood, such as sleep disturbance, postpartum pain, and past or current psychological trauma, act as stressors that cause proinflammatory cytokine levels to rise."

This is Why Sugar is Also a Major Factor in Depression

There's a great book on this subject, The Sugar Blues, written by William Duffy more than 35 years ago, that delves into the sugar-depression link in great detail. The central argument Duffy makes in the book is that sugar is an extremely health-harming addictive drug, and that simply making that one dietary change -- eliminating as much sugar as possible -- can have a profoundly beneficial impact on your mental health. He even advocated eliminating sugar from the diet of the mentally ill, stating it could be an effective treatment in and of itself for some people.
It's become increasingly clear that one route by which sugar is so detrimental to your mental health is because sugar consumption triggers a cascade of chemical reactions in your body that promote chronic inflammation. Further, excess sugar and fructose will distort the ratio of good to bad bacteria in your gut, which also plays an integral role in your mental health.  Sugar does this by serving as a fertilizer/fuel for pathogenic bacteria, yeast and fungi that negatively inhibit the beneficial bacteria in your gut.
For instance, recent research showed the probiotic Lactobacillus rhamnosus was found to have a marked effect on GABA levels in certain brain regions and lowered the stress-induced hormone corticosterone, resulting in reduced anxiety- and depression-related behavior. But if you consume a lot of processed foods and sweetened drinks (which are typically fructose-heavy), your gut bacteria are likely going to be severely compromised and so is your mental health! So the dietary answer for treating depression is to severely limit sugars, especially fructose, as well as grains.
It's worth noting that sugar can also lead to excessive insulin release that can lead to hypoglycemia, which, in turn, causes your brain to secrete glutamate in levels that can cause agitation, depression, anger, anxiety, panic attacks and an increase in suicide risk.
So radically reducing your sugar intake, especially fructose, to less than 25 grams per day will be one of the most powerful interventions for dealing with depression, as well as fighting chronic inflammation and supporting healthy gut bacteria. Consuming more than 25 grams of fructose a day will clearly push your brain biochemistry, and your overall health, in the wrong direction.

Relieving Gastrointestinal Inflammation May Ease Your Depressive Symptoms

We discussed the importance of limiting sugar and fructose, which is one of the primary ways to treat gastrointestinal inflammation, above. You will also want to be sure your gut is regularly "reseeded" with good bacteria, or probiotics, which are the foundation of a healthy gastrointestinal tract.
My recommendations for optimizing your gut bacteria are as follows:
  • Fermented foods are still the best route to optimal digestive health, as long as you eat the traditionally made, unpasteurized versions. Healthy choices include lassi (an Indian yoghurt drink, traditionally enjoyed before dinner), fermented raw (unpasteurrized) grass-fed organic milk such as kefir, various pickled fermentations of cabbage, turnips, eggplant, cucumbers, onions, squash and carrots, and natto (fermented soy).
  • If you regularly eat fermented foods such as these that, again, have not been pasteurized (pasteurization kills the naturally occurring probiotics), your healthy gut bacteria will thrive.
  • Probiotic supplement. Although I'm not a major proponent of taking many supplements (as I believe the majority of your nutrients need to come from food), probiotics are definitely an exception. I have used many different brands over the past 15 years and there are many good ones out there.
  • If you do not eat fermented foods, taking a high-quality probiotic supplement certainly makes a lot of sense considering how important they are to optimizing your mental health.
Probiotics have a direct effect on brain chemistry, transmitting mood- and behavior-regulating signals to your brain via the vagus nerve, which is yet another reason why your intestinal health can have such a profound influence on your mental health, and vice versa. Two other important factors to treat gastrointestinal inflammation and also help relieve depression are:
There's a wealth of evidence showing gastrointestinal involvement in a variety of neurological disease. With this in mind, it should also be crystal clear that nourishing your gut flora with good bacteria is extremely important, from cradle to old age, because in a very real sense you have two brains, one inside your skull and one in your gut, and each needs its own vital nourishment.

Depression - Disease or Infammation?

Is Depression a Disease—or a Symptom of Inflammation?

by Chris Kresser

The idea that depression and other mental health conditions are caused by an imbalance of chemicals (particularly serotonin and norepinephrine) in the brain is so deeply ingrained in our collective psyche that it seems almost sacrilegious to question it. 
Of course Big Pharma has played a role in perpetuating this idea. Antidepressant drugs, which are based on the chemical imbalance theory, represent a $10 billion dollar market in the U.S. alone. According to the CDC, 11 percent of Americans over 12 years old take antidepressants, and they are the second-most prescribed medications (after cholesterol-lowering drugs). Doctors wrote a staggering 254 million prescriptions for antidepressants in 2010. (1)
New research suggests that depression may be primarily caused by inflammation.
Yet as popular as this theory has become, it is riddled with problems. For example: 
  • Reducing levels of norepinephrine, serotonin and dopamine does not produce depression in humans, even though it appears to do so in animals.
  • Although some depressed patients have low levels of serotonin and norepinephrine, the majority do not. Several studies indicate that only 25 percent of depressed patients have low levels of these neurotransmitters.
  • Some depressed patients have abnormally high levels of serotonin and norepinephrine, and some patients with no history of depression have low levels of them. (2)
What if depression isn’t caused by a “chemical imbalance” after all? More specifically, what if depression itself is not a disease, but a symptom of an underlying problem? 
That is exactly what the most recent research on depression is telling us. A new theory called the “Immune Cytokine Model of Depression” holds that depression is not a disease itself, but instead a “multifaceted sign of chronic immune system activation.” (3)
To put it plainly: depression may be a symptom of chronic inflammation.

The connection between depression and inflammation

A large body of research now suggests that depression is associated with a low-grade, chronic inflammatory response and is accompanied by increased oxidative stress. 
In an excellent review paper by Berk et al, the authors presented several lines of evidence supporting the connection between depression and inflammation: (4)
  • Depression is often present in acute, inflammatory illnesses. (5)
  • Higher levels of inflammation increase the risk of developing depression. (6)
  • Administering endotoxins that provoke inflammation to healthy people triggers classic depressive symptoms. (7)
  • One-quarter of patients who take interferon, a medication used to treat hepatitis C that causes significant inflammation, develop major depression. (8)
  • Remission of clinical depression is often associated with a normalization of inflammatory markers. (9)
During an inflammatory reaction, chemicals called “cytokines” are produced. These include tumor necrosis factor (TNF)α, interleukin (IL)-1, interferon (IFN)ɣ, and interleukin (IL)-10, among others. Researchers discovered in the early 1980s that inflammatory cytokines produce a wide variety of psychiatric and neurological symptoms which perfectly mirror the defining characteristics of depression. (10)
Interestingly enough, antidepressants (particularly SSRIs) have been shown to reduce the production of pro-inflammatory cytokines like TNF-α, IL-1, interferon IFN-ɣ and increase the production of anti-inflammatory cytokines like IL-10. (11, 12) They also change the gene expression of some immune cells that are involved in inflammatory processes. This suggests that SSRIs are anti-inflammatory, which would explain their mechanism of action if inflammation is a primary driver of depression.
The research on this topic is robust, and the connection between depression and inflammation is now well-established. But if depression is primarily caused by inflammation, the obvious question that arises is, “what is causing the inflammation?”

Common causes of inflammation and depression

If you’ve been following my blog for any length of time, you know that inflammation is at the root of nearly all modern disease, including diabetes, Alzheimer’s, cardiovascular disease, autoimmune disease, allergies, asthma, and arthritis. So perhaps it shouldn’t come as much of a surprise that depression is also caused by inflammation. 
The downside of this connection is that our modern diet and lifestyle are full of factors that provoke inflammation—and thus cause disease. The upside is that if we address these factors and reduce inflammation, we can prevent and even reverse the chronic, inflammatory diseases that have become such a fixture of industrial civilization.
According to the authors of the Berk et al review paper I referenced above, the following are the most common causes of inflammation that are associated with depression. 


There are several problems with the modern diet. It is high in foods that provoke inflammation, such as refined flour, excess sugar, oxidized (rancid) fats, trans fats, and a wide range of chemicals and preservatives. And it is low in foods that reduce inflammation, like long-chain omega-3 fats, fermented foods, and fermentable fiber. Numerous studies have associated the Western diet with major depressive disorder. (13)


One of the most harmful consequences of the modern diet has been the dramatic increase in obesity. Obesity is an inflammatory state. Studies have shown higher levels of inflammatory cytokines in obese people, and weight loss is associated with a decrease in those cytokines. (14) Obesity is closely linked with depression, and while that relationship is likely multi-factorial and complex, inflammation appears to play a significant role. (15)

Gut health

Disruptions in the gut microbiome and leaky gut (i.e. intestinal permeability) have both been shown to contribute to inflammation and correlate with depression. For example, a leaky gut permits endotoxins called lipopolysaccharide (LPS) to escape the gut and enter the bloodstream, where they provoke the release of inflammatory cytokines such as TNF-α, IL-1 and COX-2. (16) And numerous studies have linked unfavorable changes to the bacteria inhabiting our gut with major depressive disorder. (17


Stress may be one of the most obvious causes of depression, but the link between stress and inflammation is less well-known. Research has shown that psychosocial stress stimulates the pro-inflammatory cytokine network, including increases in TNF-α and IL-1. (18) These increases in inflammatory cytokines are in turn closely related to depressive symptoms, as described above. 

Physical activity

There’s a huge amount of evidence indicating that exercise is an effective treatment for depression—in many cases as effective or more so than antidepressant drugs. It has also been shown to prevent depression in healthy people with no pre-existing symptoms. (19) Interestingly enough, while exercise initially produces the same inflammatory cytokines that are associated with depression, that is quickly followed by induction of anti-inflammatory substances. (20) This is known as a hormetic effect, where an initial stressor provokes a compensatory response in the body that has positive, long-term consequences. 

Sleep deprivation

Chronic sleep loss has been shown to increase inflammatory markers even in people that are otherwise healthy. (21) And although temporary sleep deprivation has been used to therapeutically improve depression, chronic sleep loss is a well-known contributing factor to developing depression in the first place. (22

Chronic infection

Chronic infections produce ongoing inflammation, so it’s no surprise to see that depression is associated with Toxoplasma gondii, West Nile virus, Clostridium difficile, and other pathogens. (23, 24, 25

Dental caries and periodontal disease

Dental caries and periodontal disease are another source of chronic inflammation, and thus a potential cause of depression. According to one large study of over 80,000 adults, researchers found that people with depression were more likely to have tooth loss even after controlling for several demographic and health factors. (26

Vitamin D deficiency

Low levels of vitamin D are common in Western populations, and there is growing evidence linking vitamin D deficiency to depression. Vitamin D modulates immune responses to infection, including reducing inflammatory markers like TNF-α and IL-1 that are associated with depression. (27) Supplementation with vitamin D to normalize serum 25D levels has been shown to to reduce inflammatory markers in some, but not all cases. (28)

Final thoughts and recommendations

The early 1980s discovery that inflammatory cytokines produce all of the characteristic signs and symptoms of depression should have made a big splash. For the first time ever, scientists had discovered a class of molecules that were tightly and consistently associated with depression, and, when administered to healthy volunteers, produced all of the symptoms necessary for the diagnosis of depression. 
Unfortunately, the “chemical imbalance” theory continues to be the dominant paradigm for understanding depression nearly 30 years after this profound discovery, despite the weak correlation between serotonin, norepinephrine, and dopamine and depressive symptoms. There are probably several reasons for this—and you’d be correct if you guessed that some of them are financial—but I’ll leave that discussion for another time.
The significance of this finding is huge—both for patients and clinicians. It shifts our focus from viewing depression as being a disease caused by a chemical imbalance, which often requires medication to correct, to being a symptom of a deeper, underlying problem. It also leads to entirely new avenues of treatment—many of them more effective and safer than antidepressant drugs.
Understanding the physical roots of depression can have a profound effect on people who are suffering from it. Although the stigma surrounding depression has decreased in recent years, many who are depressed still carry the burden of thinking that there’s something wrong with them, and the depression they experience is “their fault”. When my patients with depression learn that there’s an underlying physiological cause of their symptoms, they often feel a tremendous sense of relief and empowerment. What’s more, when we address this underlying cause, their mood improves dramatically and they quickly realize that the self-judgment and shame they felt about being depressed was misplaced and unwarranted.  
I don’t mean to suggest that emotional and psychological factors don’t play an important role in depression. In many cases they do, and I’ve written on that topic before. However, the assumption in mainstream medicine that depression is exclusively caused by those factors is obviously not true, and too often these other potential underlying causes go unexplored. The doctor prescribes an antidepressant, the patient takes it, and that’s the end of the discussion.
With this in mind, what can you do if you’re suffering from depression? Follow these two steps:
  1. Adopt an anti-inflammatory diet and lifestyle. This means eating a nutrient-dense, whole foods diet, getting enough sleep, managing stress, engaging in appropriate (not too little or too much) physical activity, and nourishing your gut. For more on how to do this, see my book Your Personal Paleo Code.
  2. Investigate other underlying causes of inflammation. On your own or with the help of a good functional medicine practitioner, explore other possible causes of inflammation that could be contributing to depression. These include gut issues (SIBO, leaky gut, dysbiosis, infections, etc.), chronic infections (viral, bacterial, fungal), low vitamin D levels, dental caries and periodontal disease, exposure to heavy metals and mold or other biotoxins, obstructive sleep apnea, and more.
Now I’d like to hear from you. Were you aware of the link between depression and inflammation? If not, how has learning about it changed your view of depression? Have you experienced an improvement in depressive symptoms after implementing an anti-inflammatory diet and lifestyle? Let us know in the comments section.

Controversial Vaccines in India : HPV and Pentavalent

Controversial vaccine studies: Why is Bill & Melinda Gates Foundation under fire from critics in India?

By KP Narayana Kumar, ET Bureau | 31 Aug, 2014, 07.10AM IST

In 2009, several schools for tribal children in Khammam district in Telangana — then a part of undivided Andhra Pradesh — became sites for observation studies for a cervical cancer vaccine that was administered to thousands of girls aged between nine and 15. The girls were administered the Human Papilloma Virus (HPV) vaccine in three rounds that year under the supervision of state health department officials. The vaccine used was Gardasil, manufactured by Merck. It was administered to around 16,000 girls in the district, many of whom stayed in state government-run hostels meant for tribal students.

Months later, many girls started falling ill and by 2010 five of them died. Two more deaths were reported from Vadodara, Gujarat, where an estimated 14,000 children studying in schools meant for tribal children were also vaccinated with another brand of HPV vaccine, Cervarix, manufactured by GSK. Earlier in the week, the Associated Press reported that scores of teenaged girls were hospitalised in a small town in northern Colombia with symptoms that parents suspect could be an adverse reaction to Gardasil.

A standing committee on health and family welfare that investigated the irregularities pertaining to the observation studies in India tabled its report a year ago, on August 30.

The committee found that consent for conducting these studies, in many cases, was taken from the hostel wardens, which was a flagrant violation of norms. In many other cases, thumbprint impressions of their poor and illiterate parents were duly affixed onto the consent form. The children also had no idea about the nature of the disease or the vaccine. The authorities concerned could not furnish requisite consent forms for the vaccinated children in a huge number of cases.

The committee said it was "deeply shocked to find that in Andhra Pradesh out of the 9,543 [consent] forms, 1,948 forms have thumb impressions while hostel wardens have signed 2,763 forms. In  Gujarat, out of the 6,217 forms 3,944 have thumb impressions and 5,454 either signed or carried thumb impressions of guardians. The data revealed that a very large number of parents or guardians are illiterate and could not even write in their local languages, Telugu or Gujarati."

Earlier this month, taking a serious view of the death of seven tribal girls in the context of the observation studies, the Supreme Court asked the Drug Controller General of India (DCGI) and the Indian Council of Medical Research (ICMR) to explain how permissions were given.

The SC bench of justices Dipak Misra and V Gopala Gowda asked the Centre to produce relevant files that pertained to the grant of licence for trial of the HPV vaccine in India. The court also asked the Centre to appraise it of steps taken on the report of the parliamentary committee.

Shoddy Investigations

Controversial vaccine studies: Why is Bill & Melinda Gates Foundation under fire from critics in India?

When a team of health activists from an NGO that specializes in women's health named Sama visited Khammam in March 2010 on a fact-finding mission, they were told that as many as 120 girls experienced adverse reactions such as epileptic seizures, severe stomach ache, headaches and mood swings. The Sama report also said there had been cases of early onset of menstruation following the vaccination, heavy bleeding and severe menstrual cramps among many students. The standing committee pulled up the relevant state governments for the shoddy investigation into these deaths. It said it was disturbed
to find that "all the seven deaths were summarily dismissed as unrelated to vaccinations without in-depth investigations...the speculative causes were suicides, accidental drowning in well (why not suicide?), malaria, viral infections, subarachnoid hemorrhage (without autopsy) etc."

The committee said that in the context of deaths of girls classified as suicide, the role of the "HPV vaccine as a possible, if not probable, cause of suicidal ideation cannot be ruled out."

It said that an American NGO — Program for Appropriate Technology in Health (PATH) — had carried out the studies.

The committee found that the objective behind the observation studies in India primarily was to collect and record data on the effect of the vaccines on the minor subjects. Another objective was to help the relevant authorities in India make an informed opinion on introducing the vaccine into India's immunization programme.

Providing a background, the report states that on June 1, 2006, American drug regulator, the US Food and Drug Administration (USFDA) approved the first vaccine — Gardasil — to prevent HPV. According to the World Health Organisation (WHO), two HPV types causes 70% of cervical cancers. In the very same month, PATH embarked upon a large-scale, five-year project that involved observation studies, covering Peru, Vietnam and Uganda, apart from India.

The committee observed that on November 16, 2006, a draft memorandum of understanding (MoU) between PATH and the ICMR was circulated by the latter. The MoU states that the two parties desire " explore collaboration to support public sector decision regarding HPV vaccine introduction in India and to generate necessary evidence to allow the possible introduction of HPV vaccine into India's Universal Immunization Programme." That idea appears to have hit a roadblock following the deaths of the
deaths of the children during the observation studies.

The standing committee report was a shocker but it became even more significant when it was mentioned that the study was sponsored by the Bill & Melinda Gates Foundation (BMGF).

Over the past decade, Bill Gates has transformed from an IT businessman into a global philanthropist. The foundation that he set up along with his wife is involved in hundreds of projects related to healthcare for the poor. Vaccination is a significant area of work and BMGF has projects running in almost every country that's counted as poor. BMGF continues to partner PATH in a number of studies such as the ones for a Rotavirus vaccine and pneumococcal vaccine in several countries, mainly Africa and Asia.

The health ministry also has not stopped PATH, in any manner, from becoming a part of such studies in India. The NGO has been roped in for other vaccine observation studies in India wherein it partners the department of bio-technology and other government departments. Health secretary Lov Verma refused to give an answer when ET Magazine asked why PATH continued to be allowed to carry out observation studies in India even after the studies which allegedly turned fatal.

According to the BMGF, the WHO, the International Federation of Gynaecology and Obstetrics, and the Federation of Obstetric and Gynaecological Societies of India have all recommended vaccination "as a proven and highly effective preventive measure for cervical cancer. "The project used vaccines that are licensed in India and that have been administered safely around the world tens of millions of times, preventing countless cases of cervical cancer illness and death," maintains a BMGF spokesperson
in an emailed response (see GAVI & PHFI create incentives...).

The Wrong PATH

BMGF's role in funding the controversial studies, however, has led to many healthcare activists in India voicing their apprehensions. "BMGF has to take full responsibility because PATH is funded by them. It is also unethical when people championing the cause of vaccines are the same ones who are also investing in vaccine development," said V Rukmini Rao, one of the activists who filed a writ petition before the Supreme Court in connection with the HPV vaccine studies.

BMGF has funded two organizations that over the past five years have played a significant role in the country's immunization programme and are both under fire for conflict of interest. The organizations are GAVI (earlier known as Global Alliance for Vaccines and Immunization), a global aid organization that specializes in vaccination, and Public Health Foundation of India (PHFI), a public-private partnership society that BMGF co-founded with the UPA government in 2006.

Activists allege that these two institutions have a working relationship with pharma companies. The main charge against GAVI is that it has representatives from pharmaceutical companies on its board while the PHFI accepts grants from pharma companies. "BMGF and GAVI are pushing the [vaccine] agenda with governments around the world, including India," says Ritu Priya Mehrotra, professor of Social Medicine and Community Health and School of Social Sciences, Jawaharlal Nehru University, Delhi. The
community health activist says the biotechnology industry was pushing more and more vaccines into India and that the health ministry was not ensuring that adequate testing was done before recommending their use in government programmes.

"We need to follow the precautionary principle when it comes to vaccines. We do need more vaccines...but we should ensure that enough time is given for research to prove the efficacy and safety of new vaccines. The vaccines that are to be brought here should also fit our epidemiological profile," adds Mehrotra. Mehrotra adds that a network of people in aid agencies and the health bureaucracy were pushing this agenda. "They have the advantage of an existing medicalized mindset that believes vaccinations
are the perfect, safe, effective, low-cost solution for prevention of infectious diseases. There is ample evidence that this is not always the case."

Wrong Dose

In recent years, the deaths of many infants allegedly soon after they were immunized with the Pentavalent vaccine, a five-in-one shot, has contributed towards anxiety around vaccines. The vaccine has been controversial in Sri Lanka, Bhutan and Vietnam, too, where it was temporarily suspended on account of some reported post-vaccination deaths of infants.

Launched in 2011 in India, Pentavalent is a combination of five vaccines in one: diphtheria, tetanus, whooping cough, hepatitis B and haemophilus influenza type b (the bacteria that causes meningitis and pneumonia). The vaccine created a furore after many infants from across the country were reported to have died after the vaccination. A reply by the health ministry to an RTI application shows that the deaths of three infants in Tamil Nadu have "a consistent causal association to immunization",  which means the ministry confirms that there is a connection between the vaccination and the deaths. In all, 54 cases of deaths of infants who were vaccinated with Pentavalent have been classified as 'adverse events following immunization'(AEFI), nomenclature that confirms the deaths have occurred soon after vaccination.

Controversial vaccine studies: Why is Bill & Melinda Gates Foundation under fire from critics in India?

ET Magazine's questionnaires to the health secretary were unanswered. BMGF, GAVI and PHFI are in favour of Pentavalent even as a number of paediatricians and health experts have petitioned the government to take a second look at the vaccine in light of the deaths of infants.

In an opinion piece published recently in Deccan Herald titled "New Vaccines: Gates Foundation's philanthropy or business?", Dr Gopal Dabade of the All India Drug Action Network said that GAVI had committed a $165-million grant for the phased introduction of Pentavalent in India and provides a subsidy of Rs 145 per injection for five years after which the government will have to pay the total cost of the vaccines. "BMGF is a founding partner of GAVI. Its initial grant helped establish GAV  and it continues to support its work. Some of the pharmaceutical companies have affiliation with BMGF to manufacture the vaccine," Dr Dabade said.

The Controversial Report

A recent strategy document on immunization published this year by the health ministry suggests doubling the expenditure on purchase of Pentavalent. The Multi-Year Strategic Plan for the Universal Immunization Programme (UIP) makes the case that the ministry needs to double its spend on Pentavalent from Rs 312.7 crore in 2013 to Rs 773.8 crore in 2017. The report also calls for a seven-fold increase in total spend on vaccines — from Rs 510.6 crore to Rs 3,587.1 crore by the same year.

The report was drafted by a team of immunization researchers who work under the PHFI which was co-founded by BMGF and the UPA government as a public private partnership. A few experts from UNICEF and WHO were also part of the team. Interestingly, its on the basis of such multiyear plans that GAVI, also funded by BMGF, disburses grants to countries.

Started in 2000, GAVI is a first-of-its kind funding agency that brings together poor countries, donor nations, global agencies, foundations, individual donors and pharma companies to enhance vaccination in poor countries. The funding is split between governments of the developed world (74%) and corporations, foundations and individuals (26%). BMGF accounts for about a fifth of the total contributions.

The HPV vaccine, used as a part of the allegedly fatal observational studies in undivided Andhra Pradesh and Gujarat, as well as Pentavalent are both part of a range of vaccines that countries can seek co-financing support for under GAVI's scheme for new and underused vaccines.

The GAVI board comprises of a representative each of the pharma industry from the industrialized and developing countries, a sore point with some experts from the aid world. In an article in the The Guardian three years ago, leaders of international aid agencies such as Oxfam and MSF said the representatives of companies needed to step down from the GAVI board. "Pharmaceutical companies' representation on GAVI's board creates a conflict of interest. The current structure is far too cosy," said the article quoting Mohga Kamal-Yanni, a senior policy adviser with Oxfam.

In a statement to ET Magazine, GAVI defended its model: "As a public-private partnership, GAVI harnesses the capabilities of the public and private sector to maximise its impact on health and development. While we believe this model is critical for our mission, we also recognize that it requires us to manage potential conflicts of interest. Therefore, relationships with the private sector are managed through strict policies. For instance, a board member representing manufacturers will be asked to leave discussions and be excluded from voting on any issue where a potential conflict of interest is identified."

Recently, an additional secretary with the health ministry, Anuradha Gupta, was appointed as the deputy CEO of GAVI. Gupta was earlier in charge of the National Health Mission. Healthcare activists raised a furore as the international agency's board also has representation from pharmaceutical companies. The Alliance Against Conflict of Interest, an organization fighting for a legislation on the subject, highlighted Gupta's move from government to GAVI as an example.

GAVI's defences is that "Ms Gupta has brought to GAVI her deep passion and commitment to protecting maternal and child health which includes enabling them to access life-saving vaccines. She strongly supports GAVI's vision and mission which is to save children's lives and protect people's health by increasing access to immunization in poor countries."

Conflict of Interest

Similar controversies on proximity with pharma companies and conflict of interest have been raised about PHFI. While PHFI is engaged in public health and is also partnering the government in UIP, it has accepted grants from a number of pharma companies, including vaccine manufacturers. In all, PHFI has accepted grants worth around `57.65 crore from pharma companies, including Merck Sharp and Dohme, Pfizer and Sanofi, which manufacture vaccines. Sanofi is one of the many manufacturers of the controversial Pentavalent vaccine around the world.

PHFI head K Srinath Reddy asserts that the grants "that the PHFI has received from pharmaceutical companies are meant for broader educational activities, and are not intended to benefit PHFI, a pharma company or any other specific organization."

Another point that provides firepower to the critics is PHFI's McKinsey connection. An executive with the consulting company, Gautam Kumra, is present on the governing body of PHFI. Kumra's profile on McKinsey's website declares that his areas of expertise include healthcare. He is also credited with helping "one of India's leading pharmaceutical companies define its 10-year vision, redesign its organization and upgrade its capabilities to execute the vision."

In 2012, McKinsey published a report titled "Transforming India's vaccine market" in association with the Organisation of Pharmaceutical Producers of India.

The report suggests that India's vaccine market is much smaller and underpenetrated than its global peers and discusses impediments that have hampered growth of the vaccine market. The report also features a scenario as per which the optimistic case would be that the market would have hit a value of around $3.2 billion in 2020, growing at 30-35% year-on-year from 2012 onwards. "In all likelihood, there will be five "mega" vaccines of over $250 million each in size, constituting 60% of the market, namely the anti-influenza, anti-typhoid, HPV, pneumococcal and Hepatitis A," the report said.

A McKinsey spokesperson said "the consultancy does not have a working relationship with PHFI. Gautam Kumra, a senior partner at McKinsey & Company, is a member of PHFI's governing board but in an entirely personal capacity as a healthcare systems expert and not as a representative of McKinsey." The consultancy also said it had a long history of pro bono and volunteer work for private, public and social sector organizations.

Controversial vaccine studies: Why is Bill & Melinda Gates Foundation under fire from critics in India?

"PHFI is a private society cleverly disguised as a public-private partnership since some of the people in the governing body are or have been senior civil servants or public servants," adds Supreme Court lawyer and activist Prashant Bhushan. Bhushan points out that PHFI appears to have several connections with the big pharma companies and their consultants. "The PHFI appears to have a conflict of interest in advising the government of India and directing the immunization programme."

PHFI's Srinath Reddy stresses that they had received unrestricted educational grants from pharma companies towards building the capacity of health professionals for providing appropriate health care of adequate quality in primary health care settings. However, these were not connected with the PHFI's work on the immunization front, he added. "As a not-for-profit organization, PHFI receives grants from different stakeholders for funding capacity building programmes which address broader public health and health system needs, including quality of healthcare. These grants are in no way tied to any pharmaceutical product and are meant solely for educational activities." But then again the line between transferring medical knowledge and deriving commercial interests is a thin one.

New Study Correlates Autism Disorder Increase and Human Fetal DNA, Retroviral Agents in Vaccines

New Study in Journal of Public Health and Epidemiology Correlates Autism Disorder Increase and Human Fetal DNA, Retroviral Agents in Vaccines

Contact: Katie Doan, Sound Choice Pharmaceutical Institute, 206-906-9922,

SEATTLE, Sept. 8, 2014 /Christian Newswire/ -- A new study published in the September 2014 volume of the Journal of Public Health and Epidemiology reveals a significant correlation between autism disorder (AD) and MMR, Varicella (chickenpox) and Hepatitis-A vaccines.

Using statistical analysis and data from the US Government, UK, Denmark and Western Australia, scientists at Sound Choice Pharmaceutical Institute (SCPI) found that increases in autistic disorder correspond with the introduction of vaccines using human fetal cell lines and retroviral contaminants.

Even more alarming, Dr Theresa Deisher, lead scientist and SCPI founder noted that, "Not only are the human fetal contaminated vaccines associated with autistic disorder throughout the world, but also with epidemic childhood leukemia and lymphomas."

Their study comes on the heels of recent breaking news that the CDC deliberately withheld evidence of the significant increase in autism among African-American boys who were vaccinated prior to 36 months of age. (See: )

So it should come as no surprise that the FDA has known for decades about the dangers of insertional mutagenesis by using the human fetal cell lines and yet, they chose to ignore it. Instead of conducting safety studies they regulated the amount of human DNA that could be present in a vaccine to no greater than 10ng. ( )

Unfortunately, Dr. Deisher's team discovered that the fetal DNA levels ranged anywhere from 142ng - 2000ng per dose, way beyond the so-called "safe" level.

"There are a large number of publications about the presence of HERV (human endogenous retrovirus - the only re-activatable endogenous retrovirus) and its association with childhood lymphoma," noted Dr Deisher. "The MMR II and chickenpox vaccines and indeed all vaccines that were propagated or manufactured using the fetal cell line WI-38 are contaminated with this retrovirus. And both parents and physicians have a right to know this!"

Certainly these discoveries by SCPI should generate an immediate investigation by FDA officials, if not an outright ban on the use of aborted fetal cell lines as substrates for vaccine production.  There are numerous other non-human FDA-approved cell lines that can and should be used.

Dr Deisher's study is available on the Academic Journals website at:
or on their website at  

Dr. Theresa Deisher is a PhD in Molecular and Cellular Physiology from Stanford University with over 20 years in commercial biotechnology, prior to founding AVM Biotechnology and Sound Choice Pharmaceutical Institute. As an inventor of 23 issued US patents she is world-renowned for her work in  adult stem cell research and the first to discover adult cardiac derived stem cells. Dr. Deisher was a plaintiff in the US federal lawsuit to prohibit the use of taxpayer dollars for embryo destructive research, which resulted in steering science towards adult stem cell research and 14 US FDA approved adult stem cell products.


Data reveals Autism is on the rise.

Empirical Data Show Autism is On the Rise. Is it Logical to Blame the Toxins of the 1970s?

Date: 10 Sep 2014
By: SafeMinds
Comment: 0
By Cynthia Nevison, Ph.D., SafeMinds Board Member
When I was pregnant with my first son in 2007, I read that a boy in the U.S. had a 1 in 91 chance of being diagnosed with an autism spectrum disorder. A good friend was a special education teacher who attended national meetings to keep up with the latest research. She told me she’d noticed a definite increase in the number of autistic kids over the course of her career (The odds today, as most of you already know, are so much worse: 1 in 42 boys, 1 in 189 girls). My friend said that nobody really knew what was causing the increase in autism, but that the leading theory involved an upsurge of nerdy men marrying nerdy women.
When my baby was born, I was smitten. He arrived ten days past his estimated due date, weighed 7 pounds 1 ounce; he had peach fuzz on his head and deep blue eyes. He was so sweet and adorable—and so helpless and dependent on me to make wise choices for him.
A close relative, who had been stricken with polio as a boy, had died of a neurodegenerative disease at age 69. Though he recovered from polio, my family always suspected his later disease may have been caused by his boyhood illness. So I went to my son’s 2-month well baby visit glad that he would be getting DTaP and polio shots. I was surprised, however, at how many other vaccines were recommended. I left the doctor’s office feeling uneasy about injecting such a small baby with so many bioactive substances at once.
I knew there had been a controversy surrounding vaccines and, although I’d heard the link with autism had been thoroughly discredited, I decided I needed to inform myself about the issue before I went back to the doctor for my son’s 4-month visit. I earned my Ph.D. in atmospheric science from Stanford University and had 18 years of experience in scientific research when my son was born. I was very interested in making an evidence-based decision on this issue.
I was shocked and dismayed by what I learned:
  • That autism was often accompanied by devastating gastrointestinal problems.
  • That in November 1999 CDC data revealed that babies with the highest early vaccine mercury exposure had a 7.6-fold increased risk of getting autism compared to those with zero exposure. Instead of making this information public, the CDC held an off-site meeting at the Simpsonwood retreat and conference center with doctors and vaccine manufacturers to decide how to manipulate the data to make these inconvenient results go away.
I read David Kirby’s Evidence of Harm, subscribed to the SafeMinds newsletter, and had a second baby in 2009. When my second son was 9 months old the doctors were unhappy with his weight gain and diagnosed him with an eating disorder. I grew disillusioned with standard medicine during the stressful year that followed. We saw an eating therapist who told me to distract my son into eating with zany behavior and a nutritionist who gave me a list of junk foods to fatten him up. My little boy was also subjected to a number of traumatic, often botched blood draws that achieved little or nothing. It was I, with the help of a new, holistic doctor, who finally improved my son’s appetite by giving him zinc and other mineral supplements. With my second son’s eating problems I became even more grateful to SafeMinds for giving me information about children’s health that wasn’t being covered in the mainstream media.
In 2011, when SafeMinds advertised for a volunteer with an atmospheric science background, I sent them my resume and began a study looking at geographical correlations between autism and atmospheric mercury. Although I found a statistically significant correlation, I eventually became skeptical of my own study. It didn’t really make sense. The time trend in atmospheric mercury over the U.S. had been flat since at least the mid 1990s and seemed inconsistent with the sharply increasing trend I’d plotted in the autism data. In addition, the diagnosed autism rate in China, the world’s biggest coal burner and mercury emitter (and a country with horrendous air pollution), was lower than in the U.S.
Around this same time, in 2012, Philip Landrigan and colleagues published an autism research strategy that included a list of the top 10 compounds suspected of causing autism.
Having studied and taught a survey course in environmental chemistry, I recognized immediately that 3 of the first 5 compounds on their list had been banned or sharply curtailed in the 1970s. But I had little idea about the trends in some of the other compounds. So I decided to do a study, based around Landrigan’s list, to answer 2 major questions:
1) What is the time trend in autism in the United States and how much of the apparent rise is real rather than due simply to better diagnosis?
2) How does that rise in autism, if it really exists, compare to the time trends in each of the chemicals in Landrigan’s top 10 list?
My findings have been published this week in the peer-review journal Environmental Health.
The main points that I have uncovered are:
  • Diagnosed autism prevalence has risen dramatically in the U.S over the last several decades and continued to trend upward as of birth year 2005.
  • The increase in autism is mainly real, with only about 20-25 percent attributable to increased autism awareness/diagnoses, and has occurred mostly since the late 1980s.
  • In contrast to the upward trend in autism, children’s exposure to most of the top 10 toxic compounds has remained flat or decreased over this same time frame.
  • The environmental factors with time trends that correlate positively to autism include 2 vaccine-related indices: cumulative aluminum adjuvant exposure and cumulative total number of disease-doses by 18 months; polybrominated diphenyl ethers (used as flame retardants); the herbicide glyphosate (used on GM crops); and maternal obesity.
Figure 1. Autism prevalence vs. birth year for California IDEA data, derived using two independent methods:  1) Constant-age tracking of 9 year-olds over 20 years of annual reports from 1991-2010 (red) and 2) Age-resolved snapshot from the most recent report in 2010 (blue).  The slope of each curve over the same birth year interval, 1993-2001, is estimated with a least squares linear fit.  The snapshot fit (grey) spans ages 9-17 in the 2010 report.  The constant-age tracking fit spans report years 2002-2010.  The snapshot:tracking slope ratio over the 1993-2001 birth year interval is 0.80, suggesting that 80% of the tracked increase is real. 
 (Reprinted from Environmental Health 2014, 13:73 doi:10.1186/1476-069X-13-73)
Figure 1. Autism prevalence vs. birth year for California IDEA data, derived using two independent methods: 1) Constant-age tracking of 9 year-olds over 20 years of annual reports from 1991-2010 (red) and 2) Age-resolved snapshot from the most recent report in 2010 (blue). The slope of each curve over the same birth year interval, 1993-2001, is estimated with a least squares linear fit. The snapshot fit (grey) spans ages 9-17 in the 2010 report. The constant-age tracking fit spans report years 2002-2010. The snapshot:tracking slope ratio over the 1993-2001 birth year interval is 0.80, suggesting that 80% of the tracked increase is real. (Reprinted from Environmental Health 2014, 13:73 doi:10.1186/1476-069X-13-73)  Note: due to underascertainment among 5 and 6 year-olds, the age-resolved snapshot curve decreases after birth year 2003.  However, constant-age tracking of 5 year-olds suggests that autism is still increasing in birth years 2004-2005.
Of course, correlation does not mean causation, so this last point should be interpreted with caution. It also should not be taken as a comprehensive list. There are many other environmental factors I would have liked to have included in my paper, but was not able to reconstruct their trends, including prenatal ultrasound, the use of acetaminophen (Tylenol), and antibiotics. Trends in key nutrient levels like vitamin D, zinc, and magnesium may also be important.
The vaccine index correlations, on their own, would mean little, but become more significant when you consider that thousands of parents are reporting autistic regression in their children following severe adverse reactions to vaccines. The severe, obvious reactions are the exception, not the rule, among autistic kids, but these cases are real and have been conceded and compensated under U.S. law.
With children’s well-being at stake, we should be leaving no stone unturned until we get to the bottom of these parental reports. Instead, we have dismissed them with statistics and called it Science, despite knowing that in some cases those statistics were deliberately manipulated.
It’s also not enough for epidemiologists to show that most kids can tolerate the current vaccine schedule without developing autism. That’s already obvious, but it doesn’t prove there’s not a vulnerable subset of children who can’t.
The director of the NIEHS recently described air pollution as a probable “real agent involved in the increasing prevalence of ASD.” Her comments were based on the multiple epidemiological studies that have found correlations between autism and air pollution. I’ve read those studies and have been surprised that none has recognized that air quality has been improving in the U.S. over recent decades, beginning with the 1970 Clean Air Act. Can we logically expect that further reductions in air pollution will reverse the upward trend in autism?  
We owe it to our children to exert ourselves to what John F. Kennedy once described as the “discomfort of thought” and to consider the whole body of scientific evidence.
It’s time to stop resting on what JFK called the comfort of myths.
Myth #1: We are not failing to protect children against autism, rather, autism has been there all along and we’re just succeeding in diagnosing it better.
Myth #2: We can account for the upward autism trend with comfortable explanations like air pollution, which nobody likes, or with “throw-up-our-hands-and-do-nothing” explanations based on a vague convergence of multiple toxins.
Because of the “convergence of many toxins” paradigm, the mainstream scientific community has led parents to believe that we cannot know what causes autism and therefore we cannot prevent it. It’s hard to dismiss this paradigm. The many chemicals in our environment at best are not helping our kids and certainly are contributing to their overall body burden of toxins. But we also should be skeptical of these kinds of vague explanations. If they were true, would autism have such a distinct time trend, with an inflection point in the late 1980s? Especially considering that many of the worst toxins were in decline at that point? Also, despite hand-waving arguments to the contrary, there is no evidence that autism existed prior to the 1930s.
The “we can’t know” attitude also absolves scientists and doctors of responsibility for prevention, and suggests the only thing we can do is diagnose autism as early as possible in order to do behavioral intervention.
The unfortunate truth is that the environmental influences causing autism may at the same time be medically useful, even lifesaving. Rather than the current approach of blanket denial, wouldn’t it be better to confront the situation honestly and come up with solutions that promote a more optimal health outcome for children as a whole?
Parents deserve better and more honest information about how to protect their children, not only from autism, but also from the other chronic conditions that afflict so many kids these days: asthma, ADHD, and severe food allergies, many of which, like autism, are fundamentally disorders of the immune system.
Some members of the environmental health community once showed true courage in taking on powerful industries, like the lead industry, that were poisoning children’s brains
We need such leaders again to challenge the illogic of past and current explanations for the rise in autism, from nerdy parents to air pollution, to end the denial of inconvenient truths, and to act to protect innocent children.
nevison_photoCynthia Nevison, Ph.D., is a research scientist at the University of Colorado at Boulder. Her work focuses on atmospheric and environmental science.