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Pathologist Petitions FDA to Halt Pfizer Emergency Use Authorization Until Vaccine Efficacy Confirmed

By Informed Consent Action Network  | Children’s Defense Fund

The major reason for petitioning the FDA for a stay of action is that the Phase 2/3 clinical trial of the Pfizer vaccine used a presumptive RT-qPCR diagnostic test.

Connecticut pathologist Dr. Sin Hang Lee and Informed Consent Action Network (ICAN) have petitioned the U.S. Food and Drug Administration (FDA) to require accurate counts of COVID-19 cases in the Pfizer/BioNTech COVID-19 mRNA vaccine trial.

“Until an accurate count of COVID-19 cases in the vaccinated and placebo groups has been determined for vaccine efficacy evaluation, we are asking the FDA to stay its decision regarding the emergency use authorization for this vaccine,” said Dr. Lee, director of Milford Molecular Diagnostics Laboratory.

The major reason for petitioning the FDA for a stay of action is that the Phase 2/3 clinical trial of the Pfizer vaccine used a presumptive RT-qPCR diagnostic test. This test is acknowledged by the medical science community to generate high rates of false-positive results among qualified trial participants from the placebo group with minor symptoms such as a sore throat or a new cough. This is especially evident when a de facto unblinding among the trial participants has taken place, according to the petition.

The Pfizer/BioNTech vaccine trial primarily uses an RT-qPCR test that employs cycle thresholds possibly up to 44.9 to identify COVID-19 “cases.” Samples deemed positive that require high levels of amplification (cycle thresholds greater than 30 to 35) are usually false positives, said Dr. Lee.

A recent review of a COVID-19 PCR test, which was signed by 22 international scientists, emphatically stated:

“To determine whether the amplified products are indeed SARS-CoV-2 genes, biomolecular validation of amplified PCR products is essential. For a diagnostic test, this validation is an absolute must. Validation of PCR products should be performed by either running the PCR product in a 1% agarose-EtBr gel together with a size indicator (DNA ruler or DNA ladder) so that the size of the product can be estimated. The size must correspond to the calculated size of the amplification product. But it is even better to sequence the amplification product. The latter will give 100% certainty about the identity of the amplification product. Without molecular validation one cannot be sure about the identity of the amplified PCR products…”

A recent petition to the European Medicines Agency to stay their COVID-19 vaccine trials used similar arguments regarding the inaccuracy of the PCR tests being used and the need for confirmatory sequencing.

On Dec. 1, Switzerland’s medical regulator, Swissmedic, said it lacks the necessary information to approve three different coronavirus vaccines ordered by the government, including the Pfizer vaccine.

In a recent interview about the pending review of the Pfizer COVID-19 vaccine, FDA Commissioner Stephen Hahn has promised, “we will make a determination regarding safety and efficacy based upon our very stringent criteria.”

As stated in the petition, if Pfizer is unable to perform the needed sequencing tests on the 180 RNA samples to confirm their stated vaccine efficacy rate of 95%, Dr. Lee has offered to re-test the residues of these samples in his laboratory.

[Read more here]

Robert O’Leary, JD BARA, has had an abiding interest in alternative health products & modalities since the early 1970’s & he has seen how they have made people go from lacking health to vibrant health. He became an attorney, singer-songwriter, martial artist & father along the way and brings that experience to his practice as a BioAcoustic Soundhealth Practitioner, under the tutelage of the award-winning founder of BioAcoustic Biology, Sharry Edwards, whose Institute of BioAcoustic Biology has now been serving clients for 30 years with a non-invasive & safe integrative modality that supports the body’s ability to self-heal using the power of the human voice. Robert brings this modality to serve clients in Greater Springfield, Massachusetts and New England (USA) & “virtually” the world. He can also be reached at romayasoundhealthandbeauty@gmail.




Paul Offit Unwittingly Exposes Scientific Fraud of FDA’s Vaccine Licensure

By Children’s Health Defense | Collective Evolution

In Brief

  • The Facts:This article was written by By Jeremy R. Hammond, Contributing Writer, Children’s Health Defense.
  • Reflect On:Are vaccines as safe as they are marketed to be? Why has the mainstream and big health ridiculed and demonized those who question them instead of addressing and countering their points?

By telling parents not to do antibody blood tests to avoid needlessly vaccinating their child, Paul Offit unwittingly exposes scientific fraud by the FDA.

Many parents today are naturally concerned about the number of vaccine doses their children are exposed to by following the schedule recommended by the Centers for Disease Control and Prevention (CDC). To many parents, it makes sense to avoid vaccinating their children unnecessarily, and to this end a blood test can be done to determine an antibody titer, or the level of antibodies in the blood. If a child already has a protective antibody titer, indicating immunity to a given infectious disease, then there would be no reason for the child to undergo the risks associated with vaccinating against that disease.

To persuade parents that this is wrong thinking, the Children’s Hospital of Philadelphia (CHOP) has published a video in which Dr. Paul Offit argues that such blood tests are of little practical use, and that the best thing for parents to do is just to get their children all of the vaccinations strictly according to the CDC’s schedule.

Offit’s argument, however, is fallacious.

Moreover, the nature of his argument reveals how advocates of existing public vaccine policy rely on deception in order to persuade the public to comply with the wishes of the bureaucrats and technocrats who determine that policy.

In fact, properly understood in its context, Offit’s argument undercuts the case for public vaccine policy inasmuch as it highlights how, in order to get vaccine products to the market, the Food and Drug Administration (FDA) colludes with the pharmaceutical industry in what is arguably scientific fraud.

… just because someone doesn’t have a protective level of antibodies doesn’t necessarily mean that they aren’t immune.

Offit’s Argument

In the video, Paul Offit introduces himself as coming from the so-called “Vaccine Education Center” at the CHOP. Then he acknowledges parents’ concern about unnecessary vaccinations:

One thing that parents worry about, or wonder about is, do I really need a vaccine if I’ve already had one or two doses? Do I really need to finish out the schedule, for example? Or maybe I’ve already been exposed to a virus or bacteria, so I don’t really need to even get vaccines at all.

So instead, how about if I just have my blood tested to see whether or not I have a protective immune response already against that particular virus or bacteria.

But, Offit argues, this is “not as easily done as you would think” because antibody titers are not necessarily indicative of immunity.

He names the hepatitis B virus and the Haemohilus influenzae type B bacterium as examples of pathogens for which a certain quantity of antibodies in the blood is equivalent to immunity.

This is not the case, however, for other pathogens, including the measles virus; rotavirus; and the pertussis bacterium, which causes whooping cough.

With measles, having a certain antibody titer does correlate with immunity, but a lack of antibodies isn’t necessarily indicative of a lack of immunity. In Offit’s words (bold emphasis added):

However, there was an outbreak of measles in the late 1980s, early 1990s that swept through the United States that caused more than 50,000 hospitalizations and caused about 120, children mostly, to die from measles.

When people looked back at that outbreak, you found that there were many people who had been vaccinated, but who didn’t have antibodies against measles who were still protected. The reason they were still protected is they had something called memory cells. Memory immunological cells, like B- and T-cells, which then when they were exposed to the virus became activated, differentiated, made antibodies, which then protected them. So even though they didn’t have circulating antibodies in their bloodstream, they still have these memory cells in their immune system that could then respond when they were exposed. So, if you looked at those people and saw they didn’t have antibodies, you would have falsely concluded they weren’t protected when they were.

n short, just because someone doesn’t have a protective level of antibodies doesn’t necessarily mean that they aren’t immune. One can still be immune to a disease due to what is known as cell-mediated immunity, which is a different branch of the immune system from humoral, or antibody, immunity.

Conversely, Offit continues (bold emphasis added):

Sometimes you can have antibodies in your bloodstream and not be protected.

So, for example rotavirus or pertussis bacteria affect really just the mucosal surfaces. So, rotaviruses just infect the lining of the small intestine. Pertussis or whooping cough infects sort of the lining of the trachea or windpipe and the lungs. That virus and that bacteria don’t really spread into the bloodstream and cause a systemic infection. They’re so-called mucosal infections. So when you look at immunity in the bloodstream, that doesn’t necessarily predict whether or not there’s going to be adequate immunity at that mucosal surface.

n short, just because someone has a high antibody titer doesn’t mean that they are immune. Cell-mediated immunity and mucosal immunity—or both—may also—or instead—be required to provide adequate protection against disease.

Offit summarizes by saying that “titers are difficult” and “not a perfect predictor” of immunity, concluding that “the best way of knowing that you’re protected is to get the vaccines that are recommended at the time they are recommended.”

Thus, Offit dismisses the idea of trying to avoid vaccination with a blood test as practically useless while characterizing vaccination as the best guarantee of immunity.

But this argument is neither logically valid nor honest.

That it’s safe to vaccinate children according to the CDC’s schedule, by his reasoning, is merely assumed.

Legitimate Concerns about Vaccine Safety

Today, children vaccinated according to the CDC’s schedule will have received fifty doses of fourteen vaccines by the age of six. By the age of eighteen, children may may have received upwards of seventy-two doses of nineteen vaccines.

As acknowledged by the Institute of Medicine in a 2013 report, no studies have been done to test the entire vaccination schedule to determine the long-term effects of the cumulative number of vaccines and their ingredients, which include the known neurotoxins aluminum and mercury.

(Aluminum is used in some vaccines as an adjuvant, or a substance intended to provoke a stronger immune response, i.e., an increased level of antibodies. Mercury is used as a preservative. Specifically, the preservative thimerosal is about half ethylmercury by weight. It was included in numerous childhood vaccines until the turn of the century, when it was removed from most after it became publicly known that the CDC’s schedule was exposing children to cumulative levels of mercury that exceeded the government’s own safety guidelines. Multi-dose vials of the inactivated influenza vaccine, which is recommended for pregnant women and infants as young as six months, still contain thimerosal.)

Naturally, the large number of vaccine doses and the lack of safety studies, coupled with alarming rates of chronic disease and developmental disorders among children, is a cause of concern for many parents. The idea that they should try to avoid unnecessary vaccinations is certainly a reasonable one.

Yet in his response to these parents, not even the slightest effort is made by Offit to address the question of safety. That it’s safe to vaccinate children according to the CDC’s schedule, by his reasoning, is merely assumed.

That, of course, is the fallacy of begging the question. But Offit’s fallacies don’t end there.

… during the mid to late 1980s, about 40 percent of measles cases were occurring in vaccinated schoolchildren, according to a study published in the journal of the American Medical Association, JAMA, in 1990.

Vaccine Failure

To strengthen his characterization of vaccines as the best guarantee of immunity, Offit highlights cases in which vaccinated individuals did not have a protective antibody titer and yet were still immune to measles.

Naturally, he doesn’t mention that the outbreak he speaks of was to a much greater extent characterized by large numbers of children who were vaccinated and yet who still got measles.

Bringing up the phenomenon known as “vaccine failure” just wouldn’t do, given his purpose of persuading parents to vaccinate their children strictly according to the CDC’s schedule.

In fact, during the mid to late 1980s, about 40 percent of measles cases were occurring in vaccinated schoolchildren, according to a study published in the journal of the American Medical Association, JAMA, in 1990.

Most of these cases were attributed to what is known as “primary vaccine failure”, which refers to the failure of the vaccine to confer immunity. Another possible explanation was “secondary vaccine failure”, which refers to the waning effect of vaccine-conferred immunity.

For outbreaks occurring in the year 1989, according to a paper published in Clinical Microbiology Reviews in 1995, “Approximately 80% of the affected school-age children were appropriately vaccinated.” As prior studies had shown, “epidemics of measles can be sustained in school-age populations despite their having very high vaccination rates.”

Among the explanations for this were both primary and secondary vaccine failure.

Until that time, a single dose of measles vaccine was recommended for children by the CDC, to be administered between the ages of twelve and fifteen months. It was precisely because measles outbreaks were occurring in highly vaccinated populations, however, that the CDC’s Advisory Committee on Immunization Practices (ACIP) began considering adding a second dose to the schedule, to be administered between the ages of four and six years.

As the CDC itself explains in its Morbidity and Mortality Weekly Report (MMWR) of June 14, 2013, “measles outbreaks among school-aged children who had received 1 dose of measles vaccine prompted ACIP in 1989 to recommend that all children receive 2 doses of measles-containing vaccine, preferably as MMR vaccine.”

Moreover, the CDC openly acknowledges that for most children who’ve received the first dose of measles vaccine, the second dose is unnecessary.

In the CDC’s own words (with my bold emphasis), “The second dose of measles-containing vaccine primarily was intended to induce immunity in the small percentage of persons who did not seroconvert after vaccination with the first dose of vaccine (primary vaccine failure).”

Offit’s argument is that since a negative antibody titer after the first dose is not necessarily indicative of a lack of immunity, therefore parents should just go ahead and get their child the second dose, too. But that argument doesn’t make any sense. It’s a non sequitur fallacy. The conclusion simply does not follow from the premise.

Rather, the conclusion that follows, in the case of the measles vaccine, is that parents who think that the second dose might provide no additional benefit and would hence pose an unnecessary risk for their child are probably correct in their assessment.

… for the purposes of licensure by the Food and Drug Administration (FDA), vaccine manufacturers are not required to demonstrate that their product is actually protective against the target disease.

The FDA’s Unscientific Surrogate Marker of Immunity

The second part of the argument presented by Paul Offit on behalf of the Children’s Hospital of Philadelphia is that, in the case of other pathogens such as rotavirus and pertussis, a high concentration of antibodies in the blood is not a good indicator of immunity.

It does not follow, however, that there’s no point in getting a blood test to determine antibody titer.

To illustrate, if a child has not yet received any doses of pertussis vaccine and yet has a high antibody titer, it would indicate that the child has already been exposed to and successfully mounted an immune response against the bacterial infection, hence rendering vaccination an unnecessary risk.

Nevertheless, Offit is correct to conclude that, for vaccinated children, there is little use in parents getting a blood test to determine antibody titer. But that’s just because of the differences between natural and vaccine-conferred immunity.

The example of pertussis is salient. Natural immunity to pertussis confers both cell-mediated (Th1) and mucosal immunity (Th17), whereas vaccination skews the immune system toward an antibody response (Th2). And as observed in a paper published in February 2019 in the Journal of the Pediatric Infectious Diseases Society, “The Th17/Th1 response prevents infection and disease and also provides longer-lasting protection than does the Th1/Th2 response.”

In other words, the immunity conferred by natural infection is superior to that conferred by the vaccine.

In light of that acknowledged fact, now consider the fact that, for the purposes of licensure by the Food and Drug Administration (FDA), vaccine manufacturers are not required to demonstrate that their product is actually protective against the target diseaseInstead, the FDA uses antibody titers as a surrogate measure of immunity, which is unscientific precisely for the reason given by Paul Offit and the CHOP: antibody titers are not necessarily evidence of immunity.

As an example, take Infarix, the brand name for the diphtheria, tetanus, and acellular pertussis vaccine (DTaP) produced by GlaxoSmithKline Biologics (GSK). The pertussis component was approved by the FDA on the basis of blood tests to measure the antibody response to the pertussis antigens included in the vaccine.

The FDA did so even though, as GSK itself admits right on the package insert for Infarix, “The role of the different components produced by B. pertussis in either the pathogenesis of, or the immunity to, pertussis is not well understood. There is no well established serological correlate of protection for pertussis.” (Emphasis added.)

In other words, they don’t really understand how immunity to pertussis works or hence how the vaccine works (although continued science is illuminating those questions, as reflected in the recent study elucidating differences between naturally acquired and vaccine-conferred immunity). What they do know is that in most children, the vaccine stimulates the production of antibodies against the included pertussis antigens, but that doesn’t necessarily mean that the vaccine confers immunity to those children.

In short, what Offit and the CHOP fail to inform their viewers when trying to convince parents that there’s no practical use for getting antibody blood tests is that antibody production is precisely the endpoint the FDA considers for vaccine licensure as a surrogate for demonstrated immunity.

Other inconvenient facts that Offit and the CHOP choose not to disclose to their viewers are that (1) the antibody protection conferred by vaccination lasts only two to four years, (2) vaccination does not prevent people from becoming carriers and spreading pertussis to others, and (3) mass vaccination has caused a genetic shift so that the dominant strains in circulation today lack a key antigen component of the vaccine called pertactin (PRN).

As the CDC itself concluded in 2013 based on data from pertussis outbreaks in Washington and Vermont, “vaccinated patients had significantly higher odds than unvaccinated patients of being infected with PRN-deficient strains.” Hence, pertactin-deficient strains “may have a selective advantage in infecting DTaP-vaccinated persons.”

Far from providing parents with a convincing argument for why they should strictly comply with the CDC’s childhood vaccine schedule, what Paul Offit and the CHOP have provided us with in this video is a strong argument for why the very process by which vaccines obtain licensure by the FDA is scientifically invalid.

Indeed, the conclusion seems inescapable that the FDA’s use of antibody titers as a surrogate measure of immunity for the purposes of vaccine licensure amounts to scientific fraud.

Offit and the CHOP’s Undisclosed Conflicts of Interest

That Paul Offit and the Children’s Hospital of Philadelphia would produce a piece of propaganda intended to manufacture parents’ consent for public vaccine policy should come as a surprise to no one.

[Read more here]

Robert O’Leary, JD BARA, has had an abiding interest in alternative health products & modalities since the early 1970’s & he has seen how they have made people go from lacking health to vibrant health. He became an attorney, singer-songwriter, martial artist & father along the way and brings that experience to his practice as a BioAcoustic Soundhealth Practitioner, under the tutelage of the award-winning founder of BioAcoustic Biology, Sharry Edwards, whose Institute of BioAcoustic Biology has now been serving clients for 30 years with a non-invasive & safe integrative modality that supports the body’s ability to self-heal using the power of the human voice. Robert brings this modality to serve clients in Greater Springfield, Massachusetts and New England (USA) & “virtually” the world. He can also be reached at romayasoundhealthandbeauty@gmail.




12 Reasons Why Even Low Levels of Glyphosate Are Unsafe

By Zen Honeycutt | Children’s Health Defense

A California jury on Friday found Monsanto liable in a lawsuit filed by a man who alleged the company’s glyphosate-based weedkillers, including Roundup, caused him cancer and ordered the company to pay $289 million in damages. (Photo: London Permaculture/cc/flickr)

Proponents of GMOs and Glyphosate-based herbicides and staunch believers in the EPA have long argued that low levels of glyphosate exposure are safe for humans. Even our own EPA tells us that Americans can consume 17 times more glyphosate in our drinking water than European residents. The EWG asserts that 160 ppb of glyphosate found in breakfast cereal is safe for a child to consume due to their own safety assessments, and yet renowned scientists and health advocates have long stated that no level is safe.  Confusion amongst consumers and the media is rampant.

Glyphosate is the declared active chemical ingredient in Roundup and Ranger Pro, which are both manufactured by Monsanto, the original manufacturer of Agent Orange and DDT. There are 750 brands of glyphosate-based herbicides.Glyphosate based herbicides are the most widely used in the world and residues of glyphosate have been found in tap water, children’s urine, breast milk, chips, snacks, beer, wine, cereals, eggs, oatmeal, wheat products, and most conventional foods tested.

The detection of glyphosate in these foods has set off alarms of concern in households and food manufacturers’ offices around the world. Lawsuits have sprung up against companies that make food products that claim to be “100% Natural” and yet contain glyphosate residues. These lawsuits have been successful. Debates, using the argument that “the dose makes the poison,” have been pushed by media. Speculation is that these media outlets are funded by advertisers that make or sell these chemicals or have sister companies that do, and threatening their profits would be unwise for all involved – except the consumers.

It is time to set the record straight

Here are 12 reasons why there is no safe level of glyphosate herbicide residue in our food or beverages.

  1. Babies, toddlers, and young children have kidneys and livers which are underdeveloped and do not have the ability to detox toxins the way adults doTheir bodies are less capable of eliminating toxins and therefore are particularly susceptible. The American Academy of Pediatrics (AAP) has stated that children, especially, should avoid pesticides because, “prenatal and early childhood exposure to pesticides is associated with pediatric cancers, decreased cognitive function and behavioral problems.”
  2. Glyphosate does not wash, dry or cook off, and has been shown to bioaccumulate in the bone marrow, tendons and muscle tissue. Bioaccumulation of low levels over time will result in levels which we cannot predict or determine; therefore there is no scientific basis to state that the low levels are not dangerous, as they can accumulate to high levels in an unforeseeable amount of time.
  3. “There is no current reliable way to determine the incidence of pesticide exposure and illness in US children.” -AAP  Children are exposed through food, air, contact with grass and pets. How much they are being exposed to daily from all these possibilities is simply not something that we have been able to determine. Therefore no one is capable of assessing what levels are safe from any one modality of exposure because an additional low level from other modalities could add up to a high level of exposure.
    1. Ultra-low levels of glyphosate herbicides have been proven to cause non-alcoholic liver disease in a long term animal study by Michael Antoniou, Giles Eric Seralini et al.  The levels the rats were exposed to, per kg of body weight, were far lower than what is allowed in our food supply. According to the Mayo Clinic 100 million, or 1 out of 3 Americans now have liver disease. These diagnoses are in some as young as 8 years old.
    2. Ultra-low levels of glyphosate have been shown to be  endocrine and hormone disrupting. Changes to hormones can lead to birth defects, miscarriage, autoimmune disease, cancer, mental and chronic illness.
    3. The  EPA Allowable Daily Intake Levels (ADIs) of glyphosate exposure were set for a 175-pound man, not a pregnant mother, infant, or child.
    4. Glyphosate alone has been shown to be chronically toxic causing organ and cell damage. Glyphosate herbicides final formulations, have been shown to be acutely toxic, causing immediate damage at low levels.
    5. The detection of glyphosate at low levels could mean the presence of the other toxic ingredients in glyphosate herbicides on our food. Until studies are done, one must practice the Precautionary Principle. The label on glyphosate herbicides does not specify the pesticide class or “other”/“inert” ingredients that may have significant acute toxicity and can account for up to 54% of the product.
    6. Regarding the label and low-level exposure: “Chronic toxicity information is not included, and labels are predominantly available in English. There is significant use of illegal pesticides(especially in immigrant communities), off-label use, and overuse, underscoring the importance of education, monitoring, and enforcement.” – AAP. Exposure to low levels of glyphosate herbicides can occur through pregnant wives or children hugging the father who is a pesticide applicator.  The chronic health impacts such as rashes which can, years later, result in non-Hodgkin lymphoma, are often ignored, especially by low income or non-English speaking users dependent on their pesticide application occupation for survival.
    7. The EPA has admitted to not having any long-term animal studies with blood analysis on the final formulation of any glyphosate herbicides.  The EPA cannot state that the final formulation is safe.
    8. For approval of pesticides and herbicides, the EPA only requires safety studies, by the manufacturer who benefits from the sales, on the one declared active chemical ingredient—in this case glyphosate. Glyphosate is never used alone.

[Read more here]

Robert O’Leary, JD BARA, has had an abiding interest in alternative health products & modalities since the early 1970’s & he has seen how they have made people go from lacking health to vibrant health. He became an attorney, singer-songwriter, martial artist & father along the way and brings that experience to his practice as a BioAcoustic Soundhealth Practitioner, under the tutelage of the award-winning founder of BioAcoustic Biology, Sharry Edwards, whose Institute of BioAcoustic Biology has now been serving clients for 30 years with a non-invasive & safe integrative modality that supports the body’s ability to self-heal using the power of the human voice. Robert brings this modality to serve clients in Greater Springfield, Massachusetts and New England (USA) & “virtually” the world. He can also be reached at romayasoundhealthandbeauty@gmail.

 




Congress Receives Vaccine Safety Project Details Including Actions Needed for Sound Science and Transparency

By Unattributed | World Mercury Project

World Mercury Project Note: Last week, 15 dedicated children’s health and medical choice advocates joined Robert F. Kennedy, Jr. on Capitol Hill to fulfill our promise to the community to provide crucial vaccine safety information to every member of Congress. Meetings with Congressional Members, Senators, and staff took place over a four-day time period to explain WMP’s six-step Vaccine Safety Project that details the actions necessary to introduce sound science and transparency to our vaccination program. Federally elected officials can no longer ignore the chronic health conditions—tied in no small part to adverse vaccine reactions—that currently affect over half of our nation’s children. Not only are these officials now aware of the conflicts of interest and inadequate science upon which the vaccine program is built, but they have been given a common-sense plan for enacting desperately needed changes that puts children’s health first.
By the World Mercury Project Team

The long-term health effects of our vaccine program are inadequately studied and our regulatory bodies are conflicted. Childhood health epidemics have mushroomed along with the childhood vaccine schedule.

Vaccines contain many ingredients, some of which are known to be neurotoxic, carcinogenic and cause autoimmunity. Vaccines injuries can and do happen. The National Vaccine Injury Compensation Program of Health and Human Services (HHS) has awarded almost $4 billion for vaccine injuries since 1988.

Common sense dictates that these actions must be taken:

  1. Subject vaccines to a scientifically rigorous approval process.
  2. Require reporting of vaccine adverse events. Automate Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink(VSD) databases for research.
  3. Ensure all parties involved with federal vaccine approvals and recommendations are free from conflicts of interest.
  4. Reevaluate all vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) prior to the adoption of evidence-based guidelines.
  5. Study what makes some individuals more susceptible to vaccine injury.
  6. Support fully-informed consent and individual rights to refuse vaccination.

The Six Steps to Vaccine Safety

The details regarding each of the six steps to vaccine safety were discussed with members of Congress, Senators and staff to help them understand why they must act now to stop the childhood epidemics.

#1: Subject vaccines to a scientifically rigorous approval.

  • Vaccines are regulated by the FDA’s Center for Biologics Evaluation and Research (CBER) division as “biologics” and are not always put through the same level of safety testing as new pharmaceuticals, which are regulated under the Center for Drug Evaluation and Research (CDER.)
  • Vaccines, which are given to healthy patients, should be tested more rigorously than drugs because they are not given to treat an existing disease.
  • Inadequate testing currently ensures that the true risk/benefit assessments for the safety and cost of vaccines are impossible to calculate accurately.
  • These vaccines are given to about 4 million American infants annually.

#2: Require reporting of vaccine adverse events. Automate Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink(VSD) databases for research.

Reporting and study of adverse events after receipt of vaccines is currently haphazard and antiquated. Since these two databases are the primary sources of U.S. post-licensure surveillance, serious side effects of vaccination that were unclear or not seen in clinical trials will be missed.

The VAERS is the online system into which doctors and patients report adverse events after vaccination. HHS admits that the system likely records only about 1% of the actual adverse events but even after a three-year HHS/Agency for Healthcare Research and Quality (AHRQ) study showed the feasibility of automating reports using electronic medical records, Centers for Disease Control (CDC) has been non-responsive to “multiple requests to proceed with testing and evaluation.”

  • Clinical trials for vaccines typically only enroll a few thousand patients in total. When vaccines are subsequently approved for use in populations of millions of healthy individuals, it is imperative that rates of known adverse events and any new or rare adverse events are monitored.
  • Without adequate safety follow-up, serious side effects may be missed entirely putting the public at risk (examples of the past importance of safety follow-up include hormone replacement therapy, Vioxx and amphetamines).
  • There has never been a comparative study of broad health outcomes in vaccinated vs. unvaccinated populations.

The National Childhood Vaccine Injury Act (NCVIA) requires healthcare providers to report:

  • Any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine; or
  • Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination that occurs within the specified time period after vaccination.

But, in practice, this doesn’t happen. There is no consequence for failing to report an injury. There is no mechanism for prosecution of non-compliance and, therefore, no incentive for a busy doctor to report vaccine safety problems.

The VSD is a collaborative project between CDC’s Immunization Safety Office and eight private health care organizations. The VSD was started in 1990 to monitor safety of vaccines and conduct studies about rare and serious adverse events following immunization. However, research is currently hampered by lack of broad access to this publicly-funded database, variability of reporting and the statistical structure of the database.

#3: Ensure all parties involved with federal vaccine approvals and recommendations are free from conflicts of interest.

FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) is responsible for licensing vaccines. CDC’s Advisory Committee on Immunization Practices (ACIP) is responsible for adding vaccines to the recommended schedules.

  • CDC or NIH Employees whose names appear on vaccine patents can receive up to $150k in licensing fees per year (in perpetuity).
  • Regarding VRBAC, a House OGR Committee Report found that the “overwhelming majority of members, both voting members and consultants have substantial ties to the pharmaceutical industry,” and “committee members with substantial ties to pharmaceutical companies have been given waivers to participate in committee proceedings.”
  • A similar report on the ACIP found that, “The CDC grants blanket waivers to the ACIP members each year that allow them to deliberate on any subject, regardless of their conflicts, for the entire year.”

A 2009 HHS Office of the Inspector General report found that:

  • “CDC had a systemic lack of oversight of the ethics program.”
  • 97 percent of committee members’ conflict disclosures had omissions.
  • 58 percent had at least one unidentified potential conflict.
  • 32 percent had at least one conflict that remained unresolved.
  • CDC continued to grant broad waivers to members with conflicts.

All vaccine regulatory agencies must rigorously enforce their ethics policies to ensure that our vaccine program is free from financial conflicts of interest.

#4 Reevaluate all vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) prior to the adoption of evidence-based guidelines.

A yes vote by ACIP results in:

  • Mandating the vaccine to millions of children.
  • Immunity from liability for the manufacturers.
  • Inclusion in the Vaccines for Children program.

However, prior to 2012, ACIP did not use evidence-based guidelines to evaluate their vaccine recommendations. Evidence Based Practice is “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of the individual patient. It means integrating individual clinical expertise with the best available external clinical evidence from systematic research.” The final ACIP guidelines published in November of 2013 outlined clearly, for the first time, a standardized plan to evaluate the quality and strength of the research behind each recommendation for a vaccine for each population. ACIP’s recommendations include the populations, timing, spacing, number of doses, boosters and appropriate ages for each vaccine to be administered.

The CDC’s infant schedule, given to approximately 4 million babies a year, was largely adopted before these guidelines were in place. Vaccines recommended before the adoption of evidence-based guidelines should not have been “grandfathered” in. Earlier ACIP recommendations should be thoroughly reviewed in light of the new guidelines and current research.

#5 Study what makes some individuals more susceptible to vaccine injury.

The Institute of Medicine (now National Academy of Medicine) has issued three disturbing reports on the evidence for suspected and/or reported vaccine adverse events.

For 80% of the suspected vaccine adverse conditions investigated, there wasn’t enough research evidence to accept or reject vaccine causation. Of the reviews with sufficient evidence, 72% found that the vaccine did likely cause the injury.

In 2013, the IOM studied the entire Childhood Immunization Schedule and stated:

“No studies have compared the differences in health outcomes… between entirely unimmunized populations of children and fully immunized children… Furthermore, studies designed to examine the long-term effects of the cumulative number of vaccines or other aspects of the immunization schedule have not been conducted.”

The Vaccine Injury Compensation Program has paid out over $3.8 billion in compensation to victims of vaccine injury. The children and adults who have been compensated for injuries have never been studied to determine why they were injured, in an effort to make vaccines safer for everyone. Preventing vaccine injuries should be tackled as zealously as we tackle preventing infectious diseases.

Vaccine safety science, particularly long-term safety science, is inadequate to ensure children’s safety or to accurately assess risks for purposes of informed consent.

#6 Support fully-informed consent and individual rights to refuse vaccination.

The American Academy of Pediatrics statement on the ethics of informed consent includes the following stipulation, “patients should have explanations, in understandable language, of …; the existence and nature of the risks involved; and the existence, potential benefits, and risks of recommended alternative treatments (including the choice of no treatment).”

In the case of vaccination, informed consent is often ignored completely in real world settings.

By law, all health care providers in the United States who administer, to any child or adult, any of the following vaccines – diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B, Haemophilus influenzae type b (Hib), influenza, pneumococcal conjugate, meningococcal, rotavirus, human papillomavirus (HPV), or varicella (chickenpox) – shall, prior to administration of each dose of the vaccine, provide a copy to keep of the relevant current edition vaccine information materials that have been produced by the Centers for Disease Control and Prevention (CDC) to the parent or legal representative of any child to whom the provider intends to administer such vaccine, or to any adult to whom the provider intends to administer such vaccine.”

In practice, particularly when multiple vaccines are administered on the same day, many parents report that they received the Vaccine Information Sheet (VIS) as they left and there was no explanation of information before a vaccine was given. It is also rare that medical history is thoroughly discussed to identify contraindications to a vaccine. For example, a patient with a family history of autoimmunity is likely at increased risk for an autoimmune reaction after vaccination.

The following are examples of the types of information that patients may learn after the fact from the Vaccine Information Sheets:

  • “Severe events have very rarely been reported following MMR vaccination, and might also happen after MMRV. These include: Deafness, long-term seizures, coma, lowered consciousness, brain damage.”
  • Or this from the Polio VIS and several others: “As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.”

Lack of informed consent encompasses vaccine advertising as well. While television drug ads disclose the side effect risks of that drug at length, vaccine advertising does not. The patient, again, is at a disadvantage.

[Read more here]

Robert O’Leary, JD BARA, has had an abiding interest in alternative health products & modalities since the early 1970’s & he has seen how they have made people go from lacking health to vibrant health. He became an attorney, singer-songwriter, martial artist & father along the way and brings that experience to his practice as a BioAcoustic Soundhealth Practitioner, under the tutelage of the award-winning founder of BioAcoustic Biology, Sharry Edwards, whose Institute of BioAcoustic Biology has now been serving clients for 30 years with a non-invasive & safe integrative modality that supports the body’s ability to self-heal using the power of the human voice. Robert brings this modality to serve clients in Greater Springfield (MA), New England. Robert can be reached at romayasoundhealthandbeauty@gmail.com.

 




Will Environmental Devastation Occur When Genetically Engineered Salmon Escape Into the Wild?

Although salmon used to be abundant on both the east and west coasts, large, healthy populations of salmon now exist mostly in Alaska. Photo credit: Ray Plourde, Ecology Action Centre

Although salmon used to be abundant on both the east and west coasts, large, healthy populations of salmon now exist mostly in Alaska. Photo credit: Ray Plourde, Ecology Action Centre

By Brettny Hardy | EcoWatch

In late 2015, the Food and Drug Administration (FDA) gave the greenlight to AquaBounty, Inc., a company poised to create, produce and market an entirely new type of salmon. By combining the genes from three different types of fish, AquaBounty has made a salmon that grows unnaturally fast, reaching adult size twice as fast as its wild relative.

Never before has a country allowed any type of genetically engineered animal to be sold as food. The U.S. is stepping into new terrain, opening Pandora’s box. But are we ready for the consequences?

In order to answer that question, we must first look back on how we as a nation arrived at this point. Historically, the U.S. has enjoyed a rich bounty of seafood from the ocean. When I lived in Alaska, I always loved the late summer months when wild salmon would fill the rivers, making their way to spawning grounds. Fresh, wild salmon filets were delicious and abundant. And they still are.

Unfortunately, outside of Alaska, our poor management of an enormous fishing industry and important habitat has depleted fish stocks all along our coasts. Salmon species, in particular, are sensitive to environmental changes. The development and industrialization of our coast has polluted and dammed the rivers they depend on to breed. Although salmon used to be abundant on both the east and west coasts, large, healthy populations of salmon now exist mostly in Alaska.

Instead of fixing the environmental problems we have created or investing in the protection and recovery of our existing wild salmon resources, some have decided to create a new, genetically engineered fish that brings a host of its own problems and further undermines the sustainability of our food supply.

The genetically engineered salmon that the FDA approved will undertake a journey that stretches halfway around the globe in order to arrive at your dinner table. AquaBounty plans to produce the salmon eggs in a lab on Prince Edward Island in Canada, fly them to Panama to be raised, slaughtered and filleted and then bring them back to the U.S. so they can be sold to your family. How many tons of greenhouse gases are emitted during that 5,000-mile trip?

That’s a far cry from the farm-to-table experience of eating seafood caught and sold by your local fisherman. Even worse, the FDA has so far refused to require food labels, so you won’t even know if the fish you’re eating is genetically engineered.

The waste and secrecy inherent in this process is bad enough, but the environmental consequences of this decision are potentially enormous. The FDA has failed to fully examine the risks this new species of salmon may present to wild salmon—and the environment—should it escape into the wild, which even some supporters of the FDA decision acknowledge is inevitable.

Once free, these fish will enter a world where wild salmon are already in a precarious state. In this fragile environment, genetically engineered fish would compete with their wild counterparts for food and space and could even potentially interbreed with them. They will also bring new diseases and cause changes to basic food webs and ecosystem processes that are difficult to anticipate.

READ THE REST OF THIS ARTICLE…




Beware: Top 5 Cancer Causing Kids Snacks

By: David Wolfe

kids lunch school

Companies market food directly to children through T.V. and radio commercials, the internet, magazines, toys, clothing, and even through product placement in movies and video games. The total amount of money spent on marketing food to children in order to actively influence their food choices is about $10 billion a year. $10 billion to ensure that kids pick the extra-sugary cereal with the movie character on the box, or the fruit snacks full of artificial preservatives that are shaped like animals from the zoo. Marketing to children works and the fact is that the overwhelming majority of marketing directed at children is for foods with poor nutritional quality that are potentially dangerous to their health. We know that most of these products fall into the “junk food” category, but how exactly are the ingredients in these snacks affecting our health?

Related article: Quick And Clean: 40 Non-Processed Snacks That Meet Your Need For Speed

Many of the popular snacks kids love contain artificial food coloring to make the food look more appealing to children – allowing them to “taste the rainbow” and have fun with their food. Yellow 5 (tartrazine) and Red 40 are just two of the commonly used food dyes made from petroleum, which is used to enhance products such as Fruit Loops, Jell-O, Kool-Aid, macaroni and cheese, popsicles, fruit roll-ups and Nutri-Grain cereal bars, just to name a few. These dyes have been linked to serious health problems, including cancer, hyperactivity, and allergic reactions.

Related article: 20 Ways To Build A Whole Food Kitchen On A Budget

Yellow 5 and Red 40 are two out of six food colorings that are banned in the UK, but U.S. companies still use them freely in their products. So much so, it is estimated that manufacturers in the U.S. put about 15 million pounds of eight different synthetic dyes into our foods each year. While the U.S. Food and Drug Administration acknowledges that food dyes can impair the behavior of some children, it has done nothing to remove them from our food supply. The list of products containing these dyes is almost endless, but here are a few to watch out for:

Read the rest of the article…




Unregulated DIY Gene Therapy: Learn How One Man’s Fascinating Quest To Hack His Own Genes May Increase Your Lifespan

By Brian Hanley | MIT Tech Review

In a dream Brian Hanley told me about, he’s riding a bus when he meets a man in dark leather clothing. Next thing he knows, he is splayed across a tilted metal bed, being electrocuted.

Related Article: For The First Time In History A Human Has Been Injected With Controversial Genetically Modified Genes

The dream was no doubt connected to events that took place last June at a plastic surgeon’s office in Davis, California. At Hanley’s request, a doctor had injected into his thighs copies of a gene that Hanley, a PhD microbiologist, had designed and ordered from a research supply company. Then, plunging two pointed electrodes into his leg, the doctor had passed a strong current into his body, causing his muscle cells to open and absorb the new DNA.

The effort is the second case MIT Technology Review has documented of unregulated gene therapy, a risky undertaking that is being embraced by a few daring individuals seeking to develop anti-aging treatments. The gene Hanley added to his muscle cells would make his body produce more of a potent hormone—potentially increasing his strength, stamina, and life span.

Hanley, 60, is the founder of a one-man company called Butterfly Sciences, also in Davis. After encountering little interest from investors for his ideas about using DNA injections to help strengthen AIDS patients, he determined that he should be the first to try it. “I wanted to prove it, I wanted to do it for myself, and I wanted to make progress,” says Hanley.

Most gene therapy involves high-tech, multimillion-dollar experiments carried out by large teams at top medical centers, with an eye to correcting rare illnesses like hemophilia. But Hanley showed that gene therapy can be also carried out on the cheap in the same setting as liposuction or a nose job, and might one day be easily accessed by anyone.

In an attempt to live longer, some enthusiasts of anti-aging medicine already inject growth hormone, swallow fullerenes, or gulp megavitamins, sometimes with disregard for mainstream medical thinking. Now unregulated gene therapy could be the next frontier. “I think it’s damn crazy,” says Bruce Smith, a professor at Auburn University who develops genetic treatments for dogs. “But that is human nature, and it’s colliding with technology.”

Related Article: Outsmart Your Genes: Use Your DNA To Create A Healthy Life Plan

To pull off his experiment, Hanley used his scientific knowledge and part of his life savings. He put his insider know-how to work to procure supplies, order blood tests, win the sign-off of a local ethics committee, and engage a plastic surgeon who helped give him two treatments, a small dose in 2015 and then a larger one last June.

Read the rest of the article…




Tylenol During Pregnancy Linked to Autism

By ANH-USA | Alliance for Natural Healing

osteoarthritis and joint painA recent study found that boys exposed to acetaminophen (Tylenol) before birth were more likely to have symptoms of autism during childhood.

This isn’t the first time that scientists have reported a connection between using this drug during pregnancy and brain and behavior abnormalities in children. Other studies show that exposure to acetaminophen raised the risk of developing ADHD (attention deficit hyperactivity disorder) by 40%. Another study found that women taking it increased the risk of their child having behavioral problems by 70%.

Pregnant mothers aren’t the only ones who should avoid acetaminophen and other common painkillers like NSAIDS (non-steroidal anti-inflammatory drugs)—a class that includes drugs like Advil, Celebrex, and Aleve.

Consider the following:

  • By the FDA’s own calculation, acetaminophen was the leading cause of liver failure in Americans between 1998 and 2003, and there’s no reason to think that this has changed in the years since.
  • Every year, 78,000 people go to the emergency room from acetaminophen overdose, whether accidental or intentional. The problem is so bad that the FDA asked doctors to stop prescribing any medication that has more than 325 mg of acetaminophen per dose. Of course, this ignores the fact that if people feel the prescribed dose isn’t cutting the pain, many think nothing of taking an extra tablet or two.

[Read more here]

 




A.D.H.D. Nation: How Big Pharma Created The A.D.H.D. Epidemic

By Kalee Brown | Collective Evolution

christina and kids

While I was at university, many of my peers would take Adderall, a drug commonly used to treat Attention Deficit Hyperactivity Disorder (A.D.H.D.), to help them study or maintain focus while writing an exam. It was somewhat of a social norm and no one seemed to care why because it was so popular; however, I believe it is a clear representation of the social and academic pressures imposed on children to be “successful.”

It also begs the question: How are so many kids gaining access to Adderall? Author and journalist Alan Schwarz explains that American children are not only severely over-diagnosed with A.D.H.D., but also frighteningly under-educated on the drugs they’re being prescribed, so they end up selling the pills instead of taking them. Well-known for his investigative reporting on how Big Pharma manufactured the “A.D.H.D. Nation” through advertising and doctor bribery, Schwarz recently published his book A.D.H.D. Nation using a term he coined to describe the widespread mishandling and misdiagnosis of the disorder.

How A.D.H.D. Became An Over-Diagnosed Disorder

According to the Centers for Disease Control and Prevention (CDC), approximately 11% of children between the ages of 4 and 17 have been diagnosed with A.D.H.D. as of 2011. However, if you ask the American Psychiatric Association, they maintain that even though only 5% of American children suffer from the disorder, the diagnosis is actually given to around 15% of American children. This number has been steadily rising, jumping from 7.8% in 2003 to 9.5% in 2007. Schwarz identifies two main themes involved with A.D.H.D. misdiagnosis: the pharmaceutical industry’s role in pushing A.D.H.D. drugs, and doctors failing to identify the root cause of children’s behavioural issues.

In an interview with Scientific American, Schwarz explains: “Many kids have problems and need help—but those problems in many cases will derive from trauma, anxiety, family discord, poor sleep or diet, bullying at school and more. We must not abandon them. We must help. But we must also be more judicious in how we do that, rather than reflexively giving them a diagnosis of what is generally described as a serious, lifelong brain disorder.”

Big Pharma’s Role in Widespread A.D.H.D. Misdiagnosis

It’s no secret that pharmaceutical companies essentially buy out the medical industry. As with many other diseases and disorders, when it comes to A.D.H.D., pharmaceutical companies have paid doctors and researchers to overstate the dangers of A.D.H.D. and the benefits of taking their drugs and understate the negative side effects. It’s easy for people to believe this misguided information when it’s affiliated with well-known universities like Harvard and Johns Hopkins. Many people don’t even realize that these studies are funded by the very companies that profit from the drugs’ sale because that relationship is hidden in small print (source). Even though many of the advertisements Big Pharma has released state that A.D.H.D. medication is “safer than aspirin,” these drugs can have significant side effects and are actually considered to be within the same class as morphine and oxycodone due to high risk of abuse and addiction. You can’t just blame all doctors, either; many of them genuinely believe they’re helping these children because of the information they’ve been given in these studies and by Big Pharma.

Big Pharma creates advertisements for A.D.H.D. drugs that are specifically targeted at parents, describing how these drugs can improve test scores and behaviour at home, among other false claims.

One of the most controversial ones was a 2009 ad for Intuniv, Shire’s A.D.H.D. treatment, which included a child in a monster costume taking off his terrifying mask to reveal his calm, smiling self with a text reading, “There’s a great kid in there.” The FDA has stepped in multiple times, sending pharmaceutical companies warning letters or even forcing them to take down their ads because they are false, misleading, and/or exaggerate the effects of their drugs (source).

[Read more here]

Robert O'Leary 150x150Robert O’Leary, JD BARA, has had an abiding interest in alternative health products & modalities since the early 1970’s & he has seen how they have made people go from lacking health to vibrant health. He became an attorney, singer-songwriter, martial artist & father along the way and brings that experience to his practice as a BioAcoustic Soundhealth Practitioner, under the tutelage of the award-winning founder of BioAcoustic Biology, Sharry Edwards, whose Institute of BioAcoustic Biology has now been serving clients for 30 years with a non-invasive & safe integrative modality that supports the body’s ability to self-heal using the power of the human voice. Robert brings this modality to serve clients in Greater Springfield (MA), New England & “virtually” the world, with his website. He can also be reached at romayasoundhealthandbeauty@gmail.com.




The FDA Launches a Massive Attack on Supplements & How to Do Something About it

By Unattributed  | * Alliance for Natural Healing

vitamins

The long-awaited revision of FDA guidance rules for new supplements is finally here. It is very bad news. Highest-level Action Alert!

We normally publish our newsletter on Tuesday, but are sending out this issue today because of its urgency.

What we are dealing with here is whether the supplement industry is allowed to innovate and create new supplements. The FDA, working as usual on behalf of the drug industry, says no. We need your help to stop this right now. It will take a huge effort on all of our parts and we need to start immediately.

Over the last few years, one of the biggest issues facing the supplement industry has been the confusion over how to comply with the new dietary ingredient (NDI) provisions contained in the landmark Dietary Supplement Health and Education Act of 1994 (DSHEA), the main law governing supplements. For the layman, “new dietary ingredient” is usually just government jargon for “new supplement.”

Under DSHEA, any dietary supplement introduced to the market in the US after 1994 is considered “new” (an NDI) and the manufacturer must notify the FDA at least seventy-five days in advance of marketing the product.

In 2011, the FDA released a draft guidance setting forth the agency’s thinking on how companies should comply with DSHEA’s NDI requirements: how and when a NDI notification should be submitted, what information should be included, what is or is not considered an NDI, etc.

The 2011 draft guidance was a massive broadside aimed at crippling—if not eliminating—the supplement industry. An economic analysis at the time by an Emory University professor estimated that the FDA’s outrageous interpretation of the DSHEA-mandated NDI notification language would have meant:

  • the elimination of tens of thousands of supplements from the market;
  • an industry-wide cost of between $2 billion and $165 billion in animal and human product safety studies to comply with the FDA’s NDI notification protocols; and
  • the loss of between 55,270 and 104,475 jobs in the supplement industry.

ANH-USA and others submitted detailed comments to the FDA concerning its deeply flawed guidance document, and ANH-USA members flooded the agency with comments. After a major backlash of 146,000 pages of comments, Congressman Peter Roskam (R-IL) stepped in and said the FDA had reversed the intent of DSHEA, which was meant to expand, not restrict, consumer access to supplements.

ANH-USA and our partners were then able to persuade Congress to add language to an appropriations bill urging the FDA to go back to the drawing board, and the agency eventually agreed. We have been waiting for the agency’s updated draft ever since.

We need to keep in mind some history about this and in particular why DSHEA was passed in the first place. In 1992, the FDA published its Task Force Report on Dietary Supplements. It included the statement that dietary supplements represented a disincentive for patented drug research.”

This report, plus the news that the clinic of Dr. Jonathan Wright had been raided at gunpoint (later referred to as “The Great B Vitamin Bust”), sent shockwaves through every integrative doctor’s office and every health food store in America.

News of this raid turned out to be the shot heard ’round the world for health freedom. Everybody got organized and started to fight back.

By 1994, over two million letters went to Congress, which led to the passage of DSHEA. Congress for the first time began to have an inkling that diet mattered greatly for health and that dietary supplements could make a great deal of difference in our diet. When President Bill Clinton signed the bill into law, he stated that it represented “common sense.”

The draft of regulations governing new dietary supplements under DSHEA, arriving twenty-two years after the passage of the legislation, and further delayed after the disastrous first draft in 2011, was finally published last Friday. It is a little better in some respects, but the biggest problems remain. It represents a dire threat to the supplement industry and, by extension, consumer access to supplements.

First, the improvements. In the original guidance, the FDA had said that all dietary ingredients contained in supplements sold before 1994, but not marketed as a standalone dietary supplement, required a NDI notification. So if a green tea supplement marketed before 1994 also contained other natural dietary ingredients, the green tea would be grandfathered and not require a NDI, but the other ingredients would—an absurd stance that has been corrected in the new guidance. Now, dietary ingredients that were marketed as or were contained in dietary supplements before 1994 are grandfathered.

The FDA’s new guidance also allows the submission of “NDI master files,” which contain specifications and other information needed to completely describe an ingredient. If a company wants to make several products with the same ingredient but at different dosages or concentrations, this could save a lot of time. These master files can also be shared with other companies to avoid excessive duplication.

There is still no authoritative list of “grandfathered” ingredients that do not need to submit NDIs, but FDA has said in the new guidance that it is willing to develop such a list based on independent and verifiable data. This appears to be just another stalling tactic after twenty-two years of stalling. We can be sure that the agency will keep the list as short as possible.

Unfortunately, that is the extent of the improvements in the new guidance versus the first draft. Most of the other problems that were in the original guidance remain in the updated draft.

The guidance imposes safety requirements on new supplements that are not even expected of drugs! The FDA describes how to determine what kind of safety studies to submit with an NDI notification. Note that safety studies in the past have been required of drugs, not of supplements. In addition the agency states that additional safety studies may be needed if the target population changes. For example, if a history of safe use has been established with adults, but a substance will be used in a dietary supplement marketed for young children, the FDA would require another NDI notification.

[Read more here]

*Originally entitled: “FDA: Massive Attack on Supplements”

Robert O'Leary 150x150

Robert O’Leary, JD BARA, has had an abiding interest in alternative health products & modalities since the early 1970’s & he has seen how they have made people go from lacking health to vibrant health. He became an attorney, singer-songwriter, martial artist & father along the way and brings that experience to his practice as a BioAcoustic Soundhealth Practitioner, under the tutelage of the award-winning founder of BioAcoustic Biology, Sharry Edwards, whose Institute of BioAcoustic Biology has now been serving clients for 30 years with a non-invasive & safe integrative modality that supports the body’s ability to self-heal using the power of the human voice. Robert brings this modality to serve clients in Greater Springfield (MA), New England & “virtually” the world, with his website. He can also be reached at romayasoundhealthandbeauty@gmail.

 




FDA Green-Lights Mutant Zika Killing Mosquito Release In Florida

By: Kristen V. Brown | Fusion

the-zika-virus

Our sci-fi future just got a whole lot closer to becoming a reality, after the Food and Drug Administration gave the okay to a field trial that would release genetically modified Zika-killing mosquitoes in the Florida Keys.

On Friday, the FDA released a final environmental assessment of the trial, finding that it “will not have significant impacts on the environment.” The project, led by Oxitec, a biotech company that focuses on insect control, calls for the release of thousands of genetically engineered male Aedes aegypti mosquitoes. The lab insects are bred so that over time they could kill off much of the local mosquito population by passing on a gene fatal to any offspring they have with wild females.

Related Article: Doctors In Argentina Believe Larvacide  (Dumped In Water Supply In 2014) Is Cause Of Zika Virus

This is not the last hurdle Oxitec faces in turning its dream of disease-obliterating mosquitoes into reality. The company will have to win the approval of the Florida Keys Mosquito Control District, which plans to vote on the proposal after issuing a survey testing local sentiment of Keys residents this fall. While past surveys have shown the project to have a majority of support, it has also had vocal naysayers. Some fear the environmental impacts that removing the Aedes aegypti mosquitoes, a non-native species, might have. Others have more imaginative objections, such as conspiracy theories about the project.

 Oxitec’s mosquitoes are engineered to include two copies of the baby-mosquito killing genes, overriding natural selection to make it almost certain that their offspring receive the killer gene from dad. Oxitec claims that trials in Brazil, Panama and the Cayman Islands have reduced mosquito populations by 90%, calling the success “an unprecedented level” of human control over nature. (The World Health Organization, which has also studied using such tactics against disease, has stated that while the technology “has demonstrated the ability to reduce the [mosquito] populations in small-scale field trials” there is still “an absence of data on epidemiological impact.”)

The FDA’s okay is a major step forward toward a U.S. implementation of the technology at a time of much concern over the spread of Zika in the U.S. after cases in Florida. Derric Nimmo, the senior scientist for Oxitec’s Keys project, told me that in the coming months much of his time will be spent going door-to-door in Key Haven, the area of the Keys where he hopes to do the release. Nimmo’s job now is to convince residents that his project is the best chance at stopping the spread of Zika in the U.S.

Everywhere else where we’ve done this there’s been 90% or better control of the population,” he said. “If we can show that it’s the same in the Key Haven, it has a really good chance of being able to prevent Zika in Miami or wherever in the U.S.”

Related Article: Dr. Mercola Pulls The Curtain Back On Zika Virus Propaganda (Get The Facts!) 

Oxitec’s mosquitoes, he said, is a solution that Keys residents don’t realize they need.

Luke Alphey, a co-founder of Oxitec and developer of the technology who no longer works with the company, said he hopes Keys residents find the FDA’s findings reassuring.

“They have looked carefully at the method and specifically at this trial, and determined it is safe,” he said. “I hope people who don’t have the time and the information to learn everything about this will take comfort in the fact that the FDA has had the time and the information, and this is their conclusion.”

Read the rest of the article…

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Obama Ready to Sign the DARK Act-Has He Been the “Monsanto” President All Along?

Monsanto-money-680x380

“Let folks know when their food is genetically modified, because Americans have a right to know what they’re buying.” (Barack Obama, 2007)

Really?

In the last eight years, the global outcry against Monsanto and the other biotech giants has accelerated—but not a significant peep has emerged from the Obama White House.

And now, the bill dubbed The Dark Act is ready for Obama’s signature. It will make GMO labels on food an exclusively federal matter—and those labels will be confusing, weak, and therefore meaningless for the majority of Americans. The Dark Act is basically a free pass for Monsanto and the other biotech giants.

After his victory in the 2008 election, Obama filled key posts with Monsanto people, in federal agencies that wield tremendous force in GMO food issues—the USDA and the FDA:

At the USDA, as the director of the National Institute of Food and Agriculture, Roger Beachy, former director of the Monsanto Danforth Center.

As deputy commissioner of the FDA, the new food-safety-issues czar, the infamous Michael Taylor, former vice-president for public policy for Monsanto. Taylor had been instrumental in getting approval for Monsanto’s genetically engineered bovine growth hormone.

As commissioner of the USDA, Iowa governor, Tom Vilsack. Vilsack had set up a national group, the Governors’ Biotechnology Partnership, and had been given a Governor of the Year Award by the Biotechnology Industry Organization, whose members include Monsanto.

As the Agriculture Trade Representative, who would push GMOs for export, Islam Siddiqui, a former Monsanto lobbyist.

As the counsel for the USDA, Ramona Romero, who had been corporate counsel for another biotech giant, DuPont.

As the head of the USAID, Rajiv Shah, who had previously worked in key positions for the Bill and Melinda Gates Foundation, a major funder of GMO agriculture research.

We should also remember that Obama’s Secretary of State, Hillary Clinton, once worked for the Rose law firm. That firm was counsel to Monsanto.

Obama nominated Elena Kagan to the US Supreme Court. Kagan, as federal solicitor general, had previously argued for Monsanto in the Monsanto v. Geertson seed case before the Supreme Court.

The deck was stacked. Obama hadn’t simply made honest mistakes. Obama hadn’t just failed to exercise proper oversight in selecting appointees. He was staking out territory on behalf of Monsanto and other GMO corporate giants.

And now let us look at what key Obama appointees have wrought for their true bosses. Let’s see what GMO crops have walked through the open door of the Obama presidency.

Monsanto GMO alfalfa.

Monsanto GMO sugar beets.

Monsanto GMO Bt soybean.

Syngenta GMO corn for ethanol.

Syngenta GMO stacked corn.

Pioneer GMO soybean.

Syngenta GMO Bt cotton.

Bayer GMO cotton.

ATryn, an anti-clotting agent from the milk of transgenic goats.

A GMO papaya strain.

Genetically engineered salmon.

This is an extraordinary parade.

Obama was, all along, a stealth operative on behalf of Monsanto, biotech, GMOs, and corporate control of the future of agriculture.

He didn’t make that many key political appointments and allow that many new GMO crops to enter the food chain through a lack of oversight.

Nor is it coincidental that two of the Obama’s biggest supporters, Bill Gates and George Soros, purchased 900,000 and 500,000 shares of Monsanto, respectively, in 2010

[Read more here]

*Originally entitled: “Monsanto’s Dark Act ready for Obama’s signature”

Robert O'Leary 150x150

Robert O’Leary, JD BARA, has had an abiding interest in alternative health products & modalities since the early 1970’s & he has seen how they have made people go from lacking health to vibrant health. He became an attorney, singer-songwriter, martial artist & father along the way and brings that experience to his practice as a BioAcoustic Soundhealth Practitioner, under the tutelage of the award-winning founder of BioAcoustic Biology, Sharry Edwards, whose Institute of BioAcoustic Biology has now been serving clients for 30 years with a non-invasive & safe integrative modality that supports the body’s ability to self-heal using the power of the human voice. Robert brings this modality to serve clients in Greater Springfield (MA), New England & “virtually” the world, with his website. He can also be reached at romayasoundhealthandbeauty@gmail.

 




Why is the CDC Scaring You Into 9 Vaccines You NEVER Need?

By S. D. Wells | Natural News

child vaccinesSure, we live in a capitalistic country, and more power to the people who run businesses and make a good living selling goods and services. But, all of those who knowingly make money off other people’s demise should be shut down and fined, and maybe even jailed. That rule of thumb should go for companies, organizations and corporations too, not to mention regulatory agencies, but that’s more of a utopian world, that doesn’t exist, and from the looks of things, probably never will.

Since the beginning of time, indigenous peoples have found natural foods, herbs, tinctures, berries, mushrooms and minerals that prevent and cure all types of infectious diseases, but in America, only a small portion of the population know about them, and some of those folks don’t even believe in them anymore. What’s the reason for that? Fear. Immense fear has been instilled in citizens by their government, that takes a few of the worst-case-scenarios for each infectious disease, and promotes propaganda to literally scare people to death (a slow death via toxic medicines).

There are pictures of children who got polio and lost the use of their limbs! There are pictures of babies covered from head to toe with smallpox and measles and chicken pox … OMG! There are nine-year-old girls being injected with a toxic jab for a benign sexually transmitted disease that’s a form of contagious cancer! Just how many nine-year-olds are engaged in sexual activity? One thing is for sure: many of those girls are going into anaphylactic shock and comas shortly after the HPV vaccine, and it’s not because they are promiscuous.

Then there are the fake diseases conjured up by the nefarious multi-billion-dollar vaccine industry, and propagated by the CDC, and hyped to the fullest extent by the mass media, with lies about breakouts and pandemics, so that everyone will rush to the nearest doctor, pharmacy or Walmart and get stuck with a needle full of MSG, mercury, formaldehyde and aluminum, not to mention combinations of genetically engineered organisms, bacteria and live viruses there really may not be a cure for. Who wants some of that?

The fact is, people don’t want to “take a chance,” because they’ve been brainwashed into believing that the only medicine that works for sickness and disease is chemical medicine made in a laboratory and “approved” by the FDA and CDC. Big mistake. Huge mistake. These are the same people who will have compromised immune systems, unpredictable pathogens in their blood, and actually become more susceptible to the very infectious diseases they’re paranoid about catching. How ironic. That’s capitalism for you. So shut up and go get stuck with poisons, or do a little homework and find out that the real conspiracy is Western medicine trying to make a fortune off the ill health they create and then treat with more damaging “medicine.”

[Read more here]

Originally entitled: “Top 9 vaccines you NEVER need and exactly why the CDC has to scare everybody into getting them”

Robert O'Leary 150x150

Robert O’Leary, JD BARA, has had an abiding interest in alternative health products & modalities since the early 1970’s & he has seen how they have made people go from lacking health to vibrant health. He became an attorney, singer-songwriter, martial artist & father along the way and brings that experience to his practice as a BioAcoustic Soundhealth Practitioner, under the tutelage of the award-winning founder of BioAcoustic Biology, Sharry Edwards, whose Institute of BioAcoustic Biology has now been serving clients for 30 years with a non-invasive & safe integrative modality that supports the body’s ability to self-heal using the power of the human voice. Robert brings this modality to serve clients in Greater Springfield (MA), New England & “virtually” the world, with his website. He can also be reached at romayasoundhealthandbeauty@gmail.

 

 




FDA Releases New Warning About Antibiotics

By Joe Graedon | People’s Pharmacy

antibiotics GCN

It took the FDA decades to recognize the serious and potentially irreversible side effects of Cipro and Levaquin antibiotics. We hope the new warning works.

  • Ciprofloxacin (Cipro)
  • Gemifloxacin (Factive)
  • Levofloxacin (Levaquin)
  • Moxifloxacin (Avelox)
  • Norfloxacin (Noroxin)
  • Ofloxacin (Floxin)

These antibiotics have been on the market for more than 30 years. Physicians and patients assumed that they were quite safe. These drugs were routinely prescribed for sinus, lung and urinary tract infections with barely a second thought. But now the FDA has issued a stern warning (May 12, 2016):

“The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolone should be reserved for those who do not have alternative treatment options.

“An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.”

We Have been Warning You about Cipro and Levaquin Antibiotics!

For more than 20 years we have been warning readers of The People’s Pharmacy that FQ antibiotics posed serious risks. The FDA has been very slow to 1) recognize the risks and 2) warn health professionals and patients how bad the problems could be. But a patient group called the “Fluoroquinolone Toxicity 24/7 Forum” pulled no punches in describing how some patients react to this class of antibiotics:

“Fluoroquinolone toxicity has been like an atomic bomb exploding in their bodies damaging their muscles and scrambling their DNA to the point many are too sick to work, too weak to walk.”

In July 1994 we heard from a reader of our syndicated newspaper column who had received a prescription for Floxin:

“I took it for a severe sinus infection followed by pneumonia last winter. After three days of utter misery and a rash on my back, I started hallucinating. Are there other people who have had a bad reaction to this antibiotic?”

People who have experienced bad reactions to fluoroquinolones sometimes call themselves “Floxies.” That’s because flox is part of the name for such drugs. Other people described being “Floxed” by these antibiotics. What is so extraordinary is that the side effects can be permanent in some cases. Only now does the FDA seem to have realized that FQs like Cipro and Levaquin antibiotics have been prescribed way to promiscuously and the complications can be irreversible.

Fluoroquinolone Side Effects:

  • Tendon problems, tendinitis, tendon rupture (potentially disabling)
  • Digestive distress, nausea, diarrhea, constipation, stomach pain, heartburn, vomiting; super-infections, including C. diff diarrhea
  • Arthritis, muscle pain, weakness
  • Headache, dizziness, anxiety, irritability, agitation, restlessness, confusion, insomnia
  • Retinal detachment
  • Allergic reactions, skin rash, anaphylaxis (life-threatening reaction requiring immediate medical attention!)
  • Hallucinations, psychosis, seizures
  • Depression, suicidal thoughts or actions
  • Irregular heart rhythms, QT prolongation
  • Kidney or liver damage
  • Blood disorders

Symptoms of Nerve Damage from FQ Antibiotics:

  • Pain
  • Numbness
  • Changes in sensation to light touch, pain or temperature, or the sense of body position
  • Burning, tingling, weakness

What do these Symptoms Mean for Real People?

Have your eyes glazed over yet? Whenever people see a long list of side effects they tend to tune out pretty quickly. That is why those terrible prescription drug commercials you see on TV are so successful for the pharmaceutical industry. After a few seconds people tend to ignore the calm voice of the announcer as he reads off a list of seemingly ridiculous adverse reactions. The problem is that these terrible complications do happen to people and sometimes change their lives forever:

Bonnie in San Luis Obispo, CA:

“I took Levaquin for a respiratory infection in May of 2008. I started having problems with my right leg shortly after, but didn’t make the connection to the drug. Then in October of 2008, I was prescribed Cipro for a UTI [urinary tract infection] and took one pill and could not move my arms or legs.

“I looked at the insert and noticed the black box warning of tendon ruptures which had only recently been put on fluoroquinolones. It was then I realized that I had taken the Levaquin earlier and was suffering from muscle pain and weakness. I have gotten progressively worse over the years and been to numerous doctors. I have yet to find one who will acknowledge the connection between this drug and my deteriorating condition.”

Debbie in Chicago shares this sad story:

“In the early 90’s, I took Cipro for pneumonia and could not walk for 15 months. The pain was unbearable. I lost my job and was a single Mother. The pain disappeared out of nowhere.

“In June of 2009 I took Levaquin, 2 pills total. I was healthy, happy, good job and no problems in my life. Until the pill I had a mild chest cold. I was in the doctor’s office for 10 minutes and was prescribed Levaquin. Pill #2 caused burning, painful feet. I was going to the health club after work with a co-worker. We both noticed something was really wrong with me. I had a sudden inability to walk due to horrible pain. I had to quit working out. I suffered in pain in order to work, shop, and care for my ill Mother.

“I kept the pain to myself but slept as soon as work and dinner was done. Fatigue set in quickly and everything became worse even after seeing 12 different doctors to figure out why I wasn’t able to walk and why I was in so much pain. I got the usual diagnosis of plantar fasciitis and was offered physical therapy and orthodics. Each doctor who found me getting worse had no answer.

“From June 2009 until now I have been in a wheel chair and cannot step down on my left foot. The severe pain and weakness has traveled from my foot through the whole left side of my body. I do not leave my home to socialize or shop. I only leave to see my doctor because of pain flare ups. Socializing in pain is not fun for me nor can I handle interaction. I cry daily, I am full of dread for the loss of my real self and all I worked for. ALL my dreams are gone. I still do not understand how I went to a doctor I trusted to make me well and instead he ruined my life in a very inhumane way.”

J.T. shares his horrifying psychological reaction:

“Several years ago I was prescribed Floxin. I took the first dose at bedtime. At 2:00 a.m. I woke up hallucinating that giant bats were flying around my room. It scared the heck out of me.

“Interestingly, my older sister who was a pharmacy rep at the time warned me not to take it. I shrugged her comments off as nonsense. This little brother had to learn the hard way. It was terrifying. Absolutely terrifying.

“It just makes me sad. Why do we even have to go through these experiences in the first place. Every time I hear the FDA mentioned, I simply shudder. Perhaps someone will expose the FDA similar to what has happened at the VA.”

Donnie’s mother suffered from Levaquin:

“My mother was given Levaquin and suffered terrible hallucinations, among other serious side-effects. There was talk about putting her in a nursing home.

“I found a list of side effects from Levaquin, and the doctor took her off of it. She got over the hallucinations fairly soon, but other adverse reactions to the drug persisted.”

Jay experienced another devastating complication of FQs:

“I took Cipro 8 years ago and was never informed of possible side-effects because they weren’t known yet. I’m STILL experiencing inflammation of my tendons and ligaments, particularly my Achilles’ tendons. It can be crippling, and I have a part-time gig as a freakin’ fitness instructor!

“During one flare-up I also experienced a partially detatched retina, and during other episodes of swollen tendons I experienced a peculiar muscle weakness that felt like I was coming down with the flu. I also had a persistent aching in my joints. These episodes can linger for WEEKS before they resolve.”

The Long Lasting Effects of Cipro and Levaquin Antibiotics:

Not everyone gets over FQ adverse reactions. Some people report that years later they are still suffering. The FDA seems to have finally acknowledged this when it stated that fluoroquinolones: “are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.”

[Read more here]

Originally entitled: “New FDA Warning For Popular Cipro and Levaquin Antibiotics!”

Robert O'Leary 150x150

Robert O’Leary, JD BARA, has had an abiding interest in alternative health products & modalities since the early 1970’s & he has seen how they have made people go from lacking health to vibrant health. He became an attorney, singer-songwriter, martial artist & father along the way and brings that experience to his practice as a BioAcoustic Soundhealth Practitioner, under the tutelage of the award-winning founder of BioAcoustic Biology, Sharry Edwards, whose Institute of BioAcoustic Biology has now been serving clients for 30 years with a non-invasive & safe integrative modality that supports the body’s ability to self-heal using the power of the human voice. Robert brings this modality to serve clients in Greater Springfield (MA), New England & “virtually” the world, with his website. He can also be reached at romayasoundhealthandbeauty@gmail.




Dying Patients Being Denied Access to Life-Saving Treatment

By anh-usa | Alliance for Natural HealthStayStrongandBeatCancer-35524093_m-680x380

The FDA is effectively signing the death warrant of more patients by denying them access to Dr. Burzynski’s antineoplaston cancer treatment—for no rational reason whatsoever. Please help. Action Alert!

Over the years, we’ve covered the FDA’s attacks on Dr. Stanislaw Burzynski, the trailblazing cancer doctor best known for his discovery and development of antineoplastons (ANP), which are peptides and amino acid derivatives that activate tumor-suppressing genes. Independent research has confirmed antineoplastons to be an effective cancer treatment.

As we’ve reported in the past, the conventional medical establishment has, through a succession of relentless attacks, slowly choked off patient access to antineoplastons. In July 2012, after years of failed legal attempts to shutter the Burzynski clinic completely, the FDA told Dr. Burzynski he could no longer accept children for treatment with antineoplastons during the current FDA trial. In January 2013, this ban was extended to adults. This means that under current FDA restrictions, no new patients can be treated with antineoplastons. Terminal cases who could be saved will instead die.

Since the FDA has formally forbidden new patient access to antineoplastons, the only hope of dying patients is to convince the FDA to grant a “compassionate use” or “single-patient protocol” exemption via its expanded access rule. This rule allows for the case-by-case use of an experimental or unapproved drug outside of a clinical trial if a patient has a serious or immediately life-threatening disease or condition, and has no other treatment options left.

For an individual patient to be granted access to an experimental drug in the expanded access rule, a doctor need only conclude that the experimental drug does not pose a greater risk than the disease itself. Despite this rule, the FDA has, on a number of occasions, refused to grant access to antineoplastons for patients for whom the treatment is the last shot at living. In one tragic case, a five-year-old diagnosed with aggressive brain cancer died while waiting for the FDA to approve ANP treatment. The FDA eventually did grant the child compassionate use, but by that time he was already brain dead.

In May of this year, a patient with glioblastoma (GBM) was denied access to Dr. Burzynski’s treatment because the FDA judged that “the potential benefits [did not]justify the potential risks of the treatment.” GBM is a highly malignant form of brain cancer and extremely difficult to treat. Apparently death is less risky for these patients than a natural and effective treatment which has a long history of safe use.

What is both confusing and astonishing is that the FDA representatives who denied the request did not challenge the fact that the antineoplaston treatment has no significant additional side effects when compared to standard cancer therapies. The FDA’s main point of contention seems to be that they consider antineoplastons to be an ineffective treatment for GBM, hence they see no perceived benefit to the treatment. The actual effectiveness of the treatment is not in doubt, however, having been used for many years, but that is supposed to be determined by the current FDA-approved trial.

The government actually agreed to the trial—but only if antineoplastons were combined with conventional chemotherapy, just to muddy the results and protect chemo’s primacy as a cancer treatment. And given the government’s attitude, one can only wonder if the results of the trial will ever see the light of day.

Why then is the FDA denying patients access to a potentially lifesaving treatment when nothing else works? These are exactly the kinds of situations that compassionate use and expanded access were made for—patients with no other options who want access to experimental treatments. But rather than give patients one last chance, the FDA effectively signs their death warrant by denying access to Dr. Burzynski’s antineoplaston treatment. This has to stop.

[Read more here]

 

Robert O'Leary 150x150Robert O’Leary, JD BARA, has had an abiding interest in alternative health products & modalities since the early 1970’s & he has seen how they have made people go from lacking health to vibrant health. He became an attorney, singer-songwriter, martial artist & father along the way and brings that experience to his practice as a BioAcoustic Soundhealth Practitioner, under the tutelage of the award-winning founder of BioAcoustic Biology, Sharry Edwards, whose Institute of BioAcoustic Biology has now been serving clients for 30 years with a non-invasive & safe integrative modality that supports the body’s ability to self-heal using the power of the human voice. Robert brings this modality to serve clients in Greater Springfield (MA), New England & “virtually” the world, with his website, www.romayasoundhealthandbeauty.com. He can also be reached at romayasoundhealth andbeauty@gmail.com.