More Vaccines Coming Down the Fast Track

In a way, vaccines are preventative medicine. Get the shot; develop immunity for a potentially deadly disease. Vaccine research development now wants to take the preventative mindset to a new level. Inspired by the Ebola outbreak that killed more than 11,000 people in Africa and the more recent Zika virus scare, the Coalition for Epidemic Preparedness Innovations (CEPI) has committed 460 million dollars to drive forward the development of three vaccines for Middle East respiratory syndrome (MERS), Lassa fever, and Nipah virus. The coalition is also asking the World Economic Forum for a 500 million dollar donation to enable their goal of developing two different experimental vaccines for each disease within five years.

What’s the Big Deal?

There are many serious diseases with no known curative treatment beyond fluids and rest.  So what is it about these three diseases that make them special? And what’s the hurry? According to Dr. Jeremy Farrar of the Wellcome Trust (one of the Investors in CEPI), “We know from Ebola, Zika and SARS that epidemics are among the significant threats we face to life, health and prosperity. Vaccines can protect us, but we’ve done too little to develop them as an insurance policy.” The three diseases highlighted by CEPI currently have no vaccines and no clear treatment plans. They’re also on the World Health Organization’s (WHO) list of diseases that urgently need to be addressed with research and development.

The Chosen Three

MERS

MERS is a viral respiratory infection caused by the MERS-coronavirus. Since its discovery in 2012, the WHO has confirmed nearly 1,900 cases of MERS with 666 deaths, resulting in a 35% death rate. People with the infection report varying levels of fever, cough, diarrhea, and shortness of breath. Symptoms are more severe in people with pre-existing health conditions.

While the virus itself is believed to have originated from bats, camels appear to be the current viral host. The spread of the infection is believed to be through coughing or contact with respiratory secretions. Most people contract the virus in healthcare settings. While the majority of cases of MERS have been reported in the Arabian Peninsula, South Korea experienced an outbreak that infected 82 people in three days. In 2014,  2 cases were confirmed in the U.S.

Lassa Fever

Of the three diseases fast-tracked for research and development, Lassa fever has been around the longest. It was discovered in 1969 in Nigeria. It predominantly occurs in West Africa and is transmitted to humans from the African rat, the most common rat in West Africa. Eighty percent of the people who contract Lassa fever have no symptoms other than a mild fever, but around 5,000 of the cases reported every year result in death. The cases that are fatal include symptoms of vomiting, fever, bleeding from body parts, and pain in the back, chest, and abdomen. A quarter of the survivors experience hearing loss. Lassa fever is difficult to distinguish from other hemorrhagic fevers like Ebola, yellow fever, and malaria.

Nipah Virus

Fruit bats are the natural hosts of the Nipah virus. Outbreaks of the virus occur almost every year in Bangladesh, and the virus occurs in India and surrounding countries as well. While the Nipah virus has not caused as many fatalities as the other two diseases targeted by CEPI, the death rate is more severe with nearly three-quarters of those infected dying. Symptoms of the virus include acute respiratory syndrome and acute fatal encephalitis. Nipah virus is transmitted to people through contact with pigs (a likely food source for bats), fruit bats, and raw date palm sap that has been contaminated by them.

Is This the Only Way to Accomplish This?

This is a very aggressive research and development campaign. Developing a single vaccine is a long process that takes from 10-15 years. CEPI’s goal is an ambitious one, but then that makes sense. CEPI is founded by some familiar entities, including the government of Norway, the government of India, and the Bill and Melinda Gates Foundation. In the midst of the flurry of announcements and ambition, it’s easy to ignore potential issues.

As long as camels, pigs, mice, and bats are around, these diseases will always be present. In the case of Nipah virus, vaccines won’t necessarily stop the spread of it as there has never been a case of it being transmitted from person to person. Sanitation and ensuring that people have the knowledge and option to avoid using contaminated date palm sap. It would be interesting to see how education and strategies on how to avoid African rats in Western Africa would impact the number of people who contract Lassa fever.

As we’ve seen over and over, sanitation and education make a huge difference in preventing the spread of disease. Dispersing sanitation and disease prevention information and improving living conditions has helped to stop the spread of polio, measles, and mumps. Why not utilize sanitation and education to eradicate these diseases as well? The answer is obvious. It may cost less than the development of a vaccine, but it won’t result in a product pharmaceutical companies can sell.

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Plant-Based Milk Draws “Misleading Label” Claims From Dairy Industry

The answer to an age-old question in advertising used to be simple. Got milk? Yes, America answered. But that is not our new reality. The question remains the same. The answer now? What kind of milk?

Milk is no longer something your local milkman drops off in a crate on your front porch. Milk comes in many different varieties. There are dairy versions like cow, goat, sheep, or buffalo (though the last two milks usually end up as cheeses). If you’re vegan or lactose-intolerant, there are options like almond milk, soy milk, coconut milk, rice milk, hemp milk, oat milk, pea milk…yeast milk? At this point, it’s safe to say milk is a both a universal and incredibly niche item. Cow milk is everywhere, but if you know where to look, the options magically open up.

Why on earth does this box of milk have almonds on it? This is sooooo confusing!

Protecting the People from Reading Labels

More than thirty congressional members have signed a letter to the Food and Drug Administration to ask that the FDA take “appropriate action” in regards to milk labels. While their idea of appropriate action is not specified in the letter, it’s clear that the dairy industry considers plant-based milk products a threat. Unfortunately for the current food establishment, this is not the first or last time customer demand will force them to adapt or die.

Americans are eating less meat. They’re more environmentally conscious. Allergies are also on the rise, and more people are beginning to see the correlation between what they eat and their overall health. Half of Americans consume non-dairy milk, and over one-third of them are open to plant-based eating in general. This is naturally going to open up the food market for healthy competition from alternatives to traditional meat and dairy. The “appropriate reactions” from big food companies so far have been to run to the FDA, claiming a product label like almond milk has the potential to fool customers into thinking they are buying dairy milk. Another example is Hellman’s Mayonnaise claiming consumers needed to be protected from vegan mayonnaise because it isn’t “real” mayonnaise.

Is This the System We Want?

Large corporations often handicap their competition while pretending to play the part of the consumer’s champion. Pay no attention to the fact that the vegan mayo behind the curtain is serving a growing population looking for healthier and more environmentally friendly options while egg costs have never been higher. You, the consumer, have been wronged by their confusing label. The language in the letter to the FDA from dairy state congressmen seems altruistic…until you realize they have claimed the consumer is not capable of reading a label. Why on earth does this box of milk have almonds on it? This is sooooo confusing!

Consumers have more access to information than ever before, and they’ve changed. Questioning the status quo is now the thing to do. Tactics like letters released and lawsuits filed over “misleading labels” are a system that believes people aren’t able to see the bias, and it’s also one of the reasons these industries are floundering right now. Consumers want healthier options and product accountability. Hellmann’s may have figured something out… their new vegan mayo line launched in 2016, 2 years after they tried to shut down Just Mayo.

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CBD Oil is Legal in Certain States and Federally Illegal – Officially Schedule 1

Is cannabidiol (CBD) oil illegal? Well…what country do you live in? If you answered the United States, the answer is yes. CBD oil and any “extract containing one or more cannabinoids that have been derived from any plant of the genus Cannabis” has (as of December 14, 2016) been given a new controlled substance code by the DEA and firmly classified as a schedule I substance. So, illegal.

But wait! There’s another question, guys! What state do you live in? Obviously,  if you live in a state where marijuana is legalized in all forms or in a state with legalized medical marijuana, CBD oil is freely available. There are also 16 states that have passed laws specifically allowing the prescription (super illegal by federal standards) or the study of CBD oil in the case of patients experiencing seizures, muscle spasms, and epilepsy. This leaves about 6 states where marijuana is illegal in any form. Oh, but remember, even in the states where it is legal, it is illegal to possess it in any building or facility managed by the federal government.

Why Does It Have To Be So Confusing?

CBD is available with a prescription in Australia and Canada and the U.K. Oddly enough, CBD oil is listed in the cosmetic ingredient database in the E.U. In the U.S., it’s illegal to have or use CBD oil in Idaho, for example. But every surrounding state allows it. Get your head in the game, Idaho!

The U.S. federal policy on marijuana is nonsensical. Marijuana is not legal because of the tetrahydrocannabinol (THC). CBD oil is not legal, even when tested to ensure the trace amounts of THC are below a certain threshold (which varies, although the smallest amount allowed seems to be .3%). Hemp is not legal according to the final rule released from the DEA in 2016, as it is in the genus Cannabis and classified as a schedule I like heroin (oxycontin is a schedule II drug, for reference). Not banned? A schedule III synthetic version of THC known as Dronabinol is currently accepted for medical use.

Covering Your Ass, DEA-Style

More than half of Americans believe medical marijuana should be legal. The 9th U.S. Circuit Court of Appeals took away the federal government’s ability to fund prosecution of people using medical marijuana according to state laws. In the words of former attorney general Eric Holder,

You know, we treat marijuana in the same way that we treat heroin now, and that clearly is not appropriate.”

With support for medical marijuana growing in the United States, why is the federal government dragging its heels?

The government claims there is not enough research to be sure that CBD and other cannabinoids have medicinal benefit, which is kind of a cop-out, as the research itself is illegal. The government ignores the countless stories and videos showing the amazing effect CBD oil has on people and children suffering from epilepsy, seizures, and neurological disorders. The denial of marijuana as medicine also directly contradicts the government’s Investigation of New Drugs (IND) program founded in 1978 (the program has since been closed to new patients). Under that program, there are still a tiny number of people (3) receiving medical marijuana from the federal government. So while the federal government has labeled marijuana a schedule I substance, they are also still legally dispensing marijuana to patients. But they still claim it can’t be legalized because they don’t have enough “research.”

If I’m Wrong, I Don’t Want to Know About it

So, to recap: CBD oil is banned federally due to the psychoactive compound THC (which it has in super small quantities if any) and a lack of research supporting medicinal claims, but a synthetic drug that is basically THC is legally available, and certain patients from an older (That’s where the research went!) government program have access to legal medical marijuana…from the government. Why? The current federal stance on marijuana (medicinal or otherwise) is about control of the medical marijuana market. If companies manufacturing medical marijuana extracts like CBD oil are able to control which products get through to market, they have the potential to create a monopoly. Once again, profits and market control are higher on the list of government priorities than providing medical relief to patients who truly need it.

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Bacteria Resistant to All Available Antibiotics Has Claimed Its First Victim

The doomsday predictions about antibiotic resistant superbugs sound like the plot of a science fiction movie. The bacteria are coming! Who will save us when we don’t have any options left?

Conventional medicine has allowed us to put much of the onus of taking care of ourselves on someone or something else. Why take care of yourself and build your immune system naturally (it’s hard work!) when an antibiotic can knock an infection out with a snap of the fingers? The same principle has been applied to our food supply. Rather than raise animals in humane environments on a diet designed to keep them healthy (also hard work), our food system chooses the easy route and pumps cows, pigs, and sheep full of unnecessary antibiotics.

Now a Nevada woman has died. Her death from an antibiotic-resistant superbug, the bacteria New Delhi metallo-beta-lactamase (NDM), is not notable on the surface. As of 2014, an estimated 23,000 people in the U.S. have died from bacteria like these, according to the CDC. The patient in question was a lady of 70, who had been in and out of hospitals for a two-year period in India with the last stay being in summer 2016. Not an unusual story, in and of itself. But here’s the worrying part. The CDC has determined that the NDM that the woman was infected with was untreatable by all available antimicrobial drugs in the U.S.

The Last Resort…Has Failed

There are a few antimicrobial drugs of last resort. One of them is colistin, a powerful antimicrobial not regularly used due to its damaging effect on the kidneys. While select bacteria that contain the mcr-1 (mechanism of colistin resistance 1) gene are immune to another drug, colistin functioned as a cleaner of sorts for anything else. That worked because the bacteria were not exchanging the gene. That is no longer the case. Bacteria are now exchanging the mcr-1 gene, and cases, where colistin is ineffective, began showing up in the U.S. in summer 2016. If that wasn’t enough to cause a deep and profound uneasiness, the NDM bacteria resistant to all available antibiotics didn’t even have the mcr-1 gene. This bacteria didn’t even need the gene we’ve identified as the one resistant to powerful antibiotics.

The Tipping Point

Is this the point where we find that we can’t go back? Is worldwide health going to spiral out of control, chased by ever stronger and more evolved bacteria? Indigenous tribes of foragers give us a glance at what the first line of defense, our intestinal flora, used to be. In a comparison of the microbiome of a small group of Italians and a group of Hadza foragers from Tanzania, the Hadza’s lack of exposure to antibiotics and highly seasonal, largely plant-based,  diet resulted in a much greater and more diverse microbiome. Maybe they wouldn’t be able to fend off one of the new superbugs, but they likely would not have developed them in the first place. How do we get those microbes back? Can we get those microbes back? No one seems to have a good answer for that, but it’s clear that antibiotic resistant bacteria keep putting their star players in the game while the Western diet keeps yanking any and everybody out.

Eat Your Veggies

There is magic in a well maintained digestive system. Get your fiber may be a funny old people joke…until you haven’t pooped in a few days. A diet lacking in raw, organic plant matter is never going to provide the tools needed to move things through the digestive system, which gives harmful bacteria a greater chance to develop and take over. The Western diet in its current form provides them with the food they need to thrive. If the digestive system is compromised, bacteria takes advantage of that. In that system, antibiotics will be the answer at some point, making it that much harder to cultivate the natural defenses the immune system needs.

Antibiotic-resistant bugs are not only the health industry’s fault. Factory farms cannot be assigned all of the blame either. The decline of our natural bacteria and immunities has created the perfect hosts for the bacteria strong and adaptable enough to survive modern medicine and an increasingly unhealthy way of eating.

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Trump Demurs When Asked About Vaccine Safety Commission Headed by Robert F. Kennedy Jr.

Robert F. Kennedy Jr. has released a statement revealing president-elect Donald J. Trump has appointed him to chair a commission on vaccine safety and scientific integrity in his new administration. Robert F. Kennedy Jr. is the son of Robert Kennedy and an outspoken supporter of safe vaccines. While many health professionals have expressed dismay at the involvement of Robert F. Kennedy Jr., the creation of this commission would be in line with some of the vaccine and autism concerns Trump expressed during his campaign. The media has been quick to cry anti-vaxxer, but both men are on record as being pro-vaccination, including Trump at a primary debate in 2015. “Autism has become an epidemic,” he said. “… It has gotten totally out of control. I am totally in favor of vaccines. But I want smaller doses over a longer period of time.”

Will unbiased vaccine science finally be available now that the leader of the country is willing to have this kind of discussion in a public forum? There are two factors that could help change these attitudes.

The First Factor

Even if you don’t agree with Robert F. Kennedy Jr, he is still a Kennedy. This comes with name brand recognition, political connections, money, and a legacy of a public service. As a Democrat, he also brings the potential to promote bipartisan agendas. Many movements succeed when they find the right spokesperson. Kennedy could be that person.

The Second Factor

The second factor here is Trump. Taking a position that calls anything about vaccines into question has massive negative repercussions. Most politicians’ reputations don’t recover. (Hi, Jill Stein!). It’s also proven difficult to predict what exactly Trump will do next and which of his many outlandish campaign promises he will uphold. It’s clear he has strong feelings on the subject of vaccinations, but who knows how serious he is about acting on them. According to Hope Hicks, the presidential transition national spokesperson, “The president-elect is exploring the possibility of forming a commission on autism, which affects so many families; however, no decisions have been made at this time…”

What’s Going to Happen?

The appointment of Robert F. Kennedy Jr. to a commission studying vaccine safety would be a huge comfort to people and their loved ones who are struggling with the aftermaths of bad vaccine reactions, whether neurological conditions, paralysis, or developmental disorders. It remains unclear, however, if this commission (if it does indeed happen) will be able to make a difference in vaccine safety. The pharmaceutical industry and the science they have provided is firmly entrenched in the government, medical establishment, and mainstream media. Robert F. Kennedy will have a daunting task ahead of him if he is to adjust these views in any way.

Also, see Robert Kennedy Jr. Accepts Trumps Appointment to Chair Vaccine Committee from the previous day.

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Pentavalent Vaccines – When Did Vaccines Adopt the Bulk Model?

Vaccines designed to provide immunity to three diseases in one shot, like the MMR and DTP, have become the industry standard. It’s incredibly difficult to find single doses of these vaccines. The development and availability of five-in-one vaccines are more likely to make single dose vaccines even more of a rarity. Welcome to the age of pentavalent vaccines.

What’s the Skinny?

The Global Alliance for Vaccines and Immunisations (GAVI) introduced pentavalent vaccines in 2001 (although pharmaceutical giant Sanofi Pasteur first licensed a pentavalent vaccine in 1993). The most commonly used pentavalent vaccines combine the DTP (diphtheria, tetanus, and pertussis) with vaccines designed to provide immunity for Hepatitis B and Haemophilus Influenza type-B (Hib), the bacteria that causes meningitis, pneumonia, and otitis. A typical vaccine schedule for pentavalent vaccines calls for the child to receive shots at 6, 10, and 14 weeks.

GAVI has been a big supporter of pentavalent vaccines and currently supplies 73 of the world’s poorest countries with these vaccines. These countries are primarily in Africa and across Asia, with Albania, Moldova, and Guyana also included in the list. In the 15 years since the introduction of pentavalent vaccines, their coverage has grown from 1% to 68% of people vaccinated in supported countries.

The Belle of the Ball

Why wouldn’t these vaccines be a priority? From the medical and pharmaceutical community’s viewpoint, a 5 in 1 vaccine provides many benefits. It’s easier to administer, creates less syringe waste, can be produced more quickly, and is cheaper to ship.

Pentavalent vaccines also increase coverage. Prior to the GAVI in 2000, fewer than 10% of low-income countries were giving the hepatitis B vaccine and even fewer were immunizing for Haemophilus Influenza type-B. The numbers vaccinated were minuscule in comparison to the 68% of people covered in these countries 15 years after the introduction of the pentavalent program.

Not Without Issues

The GAVI pentavalent vaccine program has been a success, although there have been bumps along the road. Quinvaxem, the most commonly used pentavalent vaccine, was suspended in Vietnam after nine children died post-vaccination in 2013. While Quinvaxem was reinstated within the same year in Vietnam, other countries in the region like Sri Lanka, India, and Bhutan also expressed safety concerns.

Breaking Out of the Bubble

Will pentavalent vaccines become the standard in all vaccine schedules the way the MMR and DTP replaced single vaccines? If you don’t think so, consider how difficult it is to find a mumps, measles, or rubella vaccine in any developed nation except Japan. Outside of Japan, they are no longer offered as separate vaccines. Since 2012, GAVI only supports Hep B and HiB as part of the pentavalent vaccine, making a similar restrictive availability more likely to become the standard for the rest of the world.

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Blood Lead Levels – Standards Up For Review

Every four years, the Center for Disease Control analyzes blood lead levels of children. Children under six whose blood levels test above 5 milligrams of lead per deciliter have enough lead in their body for the CDC to recommend a public health response.  Before 2012, the level causing concern was twice as high as today’s. The level change expanded the potential number of children needing treatment from 150,000 to 535,000. With a new National Health and Nutritional Examination Survey from 2016, there are rumors that the CDC will again lower the reference blood lead levels from 5 mg of lead per deciliter to 3.5 mg.

How Does the Lead Get There?

Lead exposure is declining in the U.S. Levels of lead in children’s bloodstream have fallen over 90% since the use of lead in paint and gasoline was banned almost forty years ago. So where is the lead coming from? The majority of the children above the reference levels of lead are primarily exposed to lead in their homes. In addition to older homes with lead-based paints and toxic soil, contaminated water is becoming common (Flint, MI is only the most publicized case).

Lead does not belong in the body. The fact that the reference level for lead in children’s blood may be lowered again is a good thing, as raising awareness and preventing lead exposure whenever possible is incredibly important. Awareness is good, but for this potential level change, local government follow-through will be likely be limited. The CDC doesn’t actually have any regulatory power with this issue, and local labs and lead testing devices are rarely accurate around the new proposed levels, 3.5 mg.

There is also the issue of cost. Lead safety programs around the country last year were allocated a 17 million dollar budget, which resulted in understaffing and an inability to handle the cases already present. The last time the lead references levels were lowered, the number of children affected by that change almost tripled. If another shift like that occurs without a corresponding budget change, it’s likely communities will be unable to rise to the challenge set by the CDC.

What Can You Do at Home?

The average blood lead level in children 1-5 years old is from 1 to 1.3 mg. Even if you or your children aren’t exposed to lead-based paint on a regular basis, the likelihood of lead being in the body is very high (if only at low levels). While the CDC is raising awareness among medical health and government officials, they are less clear on how you can help yourself.

There are ways to remove lead and other heavy metals from the body (called chelation) by adding common, healthy foods like garlic and cilantro to the diet. The higher the blood lead levels, the more likely a medical professional needs to intervene. You can address your lead level every day before it becomes a toxic overload by doing something as simple as sprinkling raw garlic on your salad or dinner.

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