Tag Archives: NVP

The FDA buries evidence of fraud in medical trials.

http://www.slate.com/articles/health_and_science/science/2015/02/fda_inspections_fraud_fabrication_and_scientific_misconduct_are_hidden_from.single.html

Agents of the Food and Drug Administration know better than anyone else just how bad scientific misbehavior can get. Reading the FDA’s inspection files feels almost like watching a highlights reel from a Scientists Gone Wild video. It’s a seemingly endless stream of lurid vignettes—each of which catches a medical researcher in an unguarded moment, succumbing to the temptation to do things he knows he really shouldn’t be doing. Faked X-ray reports. Forged retinal scans. Phony lab tests. Secretly amputated limbs. All done in the name of science when researchers thought that nobody was watching.

That misconduct happens isn’t shocking. What is: When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn’t get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.

Much of my research has to do with follies, foibles, and fraud in science, and I knew that the FDA wasn’t exactly bending over backward to correct the scientific record when its inspectors found problems during clinical trials. So as part of my investigative reporting class at New York University, my students and I set out to find out just how bad the problem was—and how much important information the FDA was keeping under wraps.

We didn’t have to search very hard to find FDA burying evidence of research misconduct. Just look at any document related to an FDA inspection. As part of the new drug application process, or, more rarely, when the agency gets a tipoff of wrongdoing, the FDA sends a bunch of inspectors out to clinical sites to make sure that everything is done by the book. When there are problems, the FDA generates a lot of paperwork—what are called form 483s, Establishment Inspection Reports, and in the worst cases, what are known as Warning Letters. If you manage to get your hands on these documents, you’ll see that, most of the time, key portions are redacted: information that describes what drug the researcher was studying, the name of the study, and precisely how the misconduct affected the quality of the data are all blacked out. These redactions make it all but impossible to figure out which study is tainted. My students and I looked at FDA documents relating to roughly 600 clinical trials in which one of the researchers running the trial failed an FDA inspection. In only roughly 100 cases were we able to figure out which study, which drug, and which pharmaceutical company were involved. (We cracked a bunch of the redactions by cross-referencing the documents with clinical trials data, checking various other databases, and using carefully crafted Google searches.) For the other 500, the FDA was successfully able to shield the drugmaker (and the study sponsor) from public exposure.

A redacted letter sent by the FDA to a clinical investigator in 2012.
A redacted letter sent by the FDA to a clinical investigator in 2012.

It’s not just the public that’s in the dark. It’s researchers, too. And your doctor. As I describe in the current issue of JAMA Internal Medicine, my students and I were able to track down some 78 scientific publications resulting from a tainted study—a clinical trial in which FDA inspectors found significant problems with the conduct of the trial, up to and including fraud. In only three cases did we find any hint in the peer-reviewed literature of problems found by the FDA inspection. The other publications were not retracted, corrected, or highlighted in any way. In other words, the FDA knows about dozens of scientific papers floating about whose data are questionable—and has said nothing, leaving physicians and medical researchers completely unaware. The silence is unbroken even when the FDA itself seems shocked at the degree of fraud and misconduct in a clinical trial.

Such was the case with the so-called RECORD 4 study. RECORD 4 was one of four large clinical trials that involved thousands of patients who were recruited at scores of clinical sites in more than a dozen countries around the world. The trial was used as evidence that a new anti-blood-clotting agent, rivaroxaban, was safe and effective. The FDA inspected or had access to external audits of 16 of the RECORD 4 sites. The trial was a fiasco. At Dr. Craig Loucks’ site in Colorado, the FDA found falsified data. At Dr. Ricardo Esquivel’s site in Mexico, there was “systematic discarding of medical records” that made it impossible to tell whether the study drug was given to the patients. At half of the sites that drew FDA scrutiny—eight out of 16—there was misconduct, fraud, fishy behavior, or other practices so objectionable that the data had to be thrown out. The problems were so bad and so widespread that, contrary to its usual practice, the FDA declared the entire study to be “unreliable.” Yet if you look in the medical journals, the results from RECORD 4 sit quietly in The Lancet without any hint in the literature about falsification, misconduct, or chaos behind the scenes. This means that physicians around the world are basing life-and-death medical decisions on a study that the FDA knows is simply not credible.

It’s not just one study, either. The FDA found major problems with sites involved in the other three clinical trials that were used to demonstrate rivaroxaban’s safety and effectiveness. RECORD 2, for example, was nearly as awful as RECORD 4: Four out of 10 sites that the FDA inspected showed evidence of misconduct, or other issues grave enough to render the site’s data worthless—including clear evidence of data falsification at one site. In aggregate, these problems raise serious doubts about the quality of all four key rivaroxaban studies—and, by extension, doubts about how seriously we should take the claim that rivaroxaban is safe and effective. The FDA is keeping mum, even as wrongful-death lawsuits begin to multiply.

The FDA’s failure to notify the public is not merely a sin of omission. In March 2009, the FDA convened a committee of outside scientific experts to mull the “robustness and meaningfulness” of the results from the four rivaroxaban trials, RECORDs 1, 2, 3, and 4. (The agency regularly calls in advisers to get advice, or, more cynically, to get cover, about a decision the agency has to make.) When the agency briefed the committee, it was (to put it mildly) coy about the problems it was finding. It said only that inspectors had found “significant issues” at two clinical sites involved in the RECORD 4 study—and that data from one of them was included in the analysis. Inspections were still ongoing, so it’s not easy to say precisely what the agency knew at that point, but it’s clear that the FDA wasn’t admitting to everything it knew. A bunch of inspections had been completed a month prior to the meeting, and we know for certain that the agency was fully aware of major issues beyond the two it revealed to the advisory committee. In a memo dated three days before the advisory committee meeting convened, the FDA detailed “falsification of data by a subinvestigator” at a RECORD 2 site. The advisory committee was not told.

By itself, this might seem like a miscommunication or an oversight, but the FDA has a history of not notifying the public about the misconduct it finds. About a decade ago, the agency got into trouble over a newly approved antibiotic, Ketek. Inspectors had found extensive problems (including fraud) affecting key clinical trials of the drug. Yet the agency did its best to hide the problems from even its most trusted advisers. As David Ross, the FDA official in charge of reviewing Ketek’s safety, put it, “In January 2003, over reviewers’ protests, FDA managers hid the evidence of fraud and misconduct from the advisory committee, which was fooled into voting for approval.” However, when the reports of misconduct at one clinical site began appearing in the press—along with stories of liver damage and blurred vision associated with the new drug—Congress stepped in, demanding information from the agency about the fraud.

But even the Senate couldn’t wring key information about the misconduct out of the FDA. “Every excuse under the sun has been used to create roadblocks,” complained an indignant Sen. Charles Grassley, “even in the face of congressional subpoenas requesting information and access to FDA employees.” The head of the FDA, Andrew von Eschenbach, attempted to explain to Congress why the agency didn’t tell its advisory committee about the problems in the Ketek study: “After considering the fact that the investigation results were preliminary … FDA decided to hold the Advisory Committee meeting as planned …” without notifying the committee of the potential problems. But Rep. Bart Stupak quickly pointed to an email, which, he argued, contradicted von Eschenbach’s testimony. “So either you are not being forthright with us, when I believe you are, but whoever is doing your work is trying to  lead this committee down the wrong path.” And the correct path showed that site after site involved in study 3014, as well as other key Ketek studies, were tainted as well.

Andrew von Eschenbach
Then–FDA Commissioner Andrew von Eschenbach before Congress on April 22, 2008.

Photo by Scott J. Ferrell/Congressional Quarterly/Getty Images

In the decade since the Ketek affair, it’s hard to see any change in behavior by the agency. On occasion, the FDA has even actively approved and promoted statements about drugs that, according to its own inspectors, are based upon falsehoods. At the end of 2011, the FDA learned that an audit of a Chinese site involved in a key clinical trial of a different anti-clotting agent, apixaban, had turned up evidence of fraud: Personnel had apparently been fiddling with patient records. Worse yet, the fraud appeared to invalidate one key finding of the study. Just three months earlier, the researchers running the trial proudly announced in the New England Journal of Medicine that there was a “significant reduction in mortality” among patients who took apixaban compared with those who took the old standby, warfarin. Alas, the moment you exclude the data from the Chinese fraud site, as per standard FDA procedure, that statement went out the window. Yet look at the label for apixaban—the one approved by the FDA after the fraud was discovered—and you read that “treatment resulted in a significantly lower rate of all-cause death … than did treatment with warfarin,” backed up by the data set with the Chinese site included. In other words, the label is carrying a claim that the FDA knows is based upon fraud. In a written response to my questions on this subject, the FDA stated that, “The FDA extended the drug’s review period to address the concerns. However, the review team did conclude concluded [sic] that the data at that site and other sites in China did reflect meaningful clinical information; that was not what was considered unreliable.”

Again, this isn’t an isolated incident. I had previously encountered bogus data on FDA-approved labels when a colleague and I were looking into a massive case of scientific misconduct —a research firm named Cetero had been caught faking data from more than 1,400 drug trials. That suddenly worthless data had been used to establish the safety or effectiveness of roughly 100 drugs, mostly generics, that were being sold in the United States. But even after the agency exposed the problem, we found fraud-tainted data on FDA-approved drug labels. (The FDA still maintains its silence about the Cetero affair. To this day, the agency refuses to release the names of the 100-odd drugs whose approval data were undermined by fraud.)

And the FDA covers up drug-related misconduct in other, more subtle ways, too. For example, the agency publishes the canonical listing of generic drugs in the United States, known as the “Orange Book.” Prescription drugs in this book are often given what’s called a “therapeutic equivalence code.” This code is a two-letter designation that signals the quality of the scientific evidence that a generic is “bioequivalent” to the name-brand drug. The code “AB,” for example, tells pharmacists and physicians that there are solid scientific studies proving that bioequivalence. Another code, “BX,” signals that there isn’t sufficient data to prove the generic is bioequivalent to the name brand.

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When the Cetero misconduct was uncovered, key bioequivalence studies for scores of generic drugs turned out to be worthless. By rights, some of those drugs should have had their designation downgraded from AB to BX. But even though the FDA updates the Orange Book monthly, there was no rash of drugs losing their AB rating in the months after the Cetero affair broke. In the year and a half after the Cetero fraud was first announced, I was able to identify a grand total of four generic drugs (in various dosages) that were downgraded to BX, none of which appeared to be linked to the Cetero problem. On the other hand, the one prescription generic drug that I knew for sure had been hit hard by the Cetero fraud—both key studies supporting its bioequivalence to the name brand were declared worthless—had no change in its designation. The FDA apparently allowed the drug to keep its AB badge for months without any valid data backing the drug’s bioequivalence. When asked, point blank, whether the agency had downgraded the bioequivalence code of any products due to the Cetero affair, officials promptly dodged the question. A written statement issued by the agency’s press office in response to my queries noted that the FDA requested additional data from the companies whose drugs were implicated in the Cetero affair and that “If the data were not provided within 6 months or the data provided did not support a finding of bioequivalence, FDA said it would consider changing the generic product’s therapeutic equivalence rating in the Orange Book from AB to BX.” Not a word about a single bioequivalence rating actually being changed.

This, too, is a pattern of behavior rather than a one-off. In the past few weeks, another major Cetero-type case began to emerge—this time, having to do with GVK Biosciences, a firm in Hyderabad, India. The European Medicines Agency, the European equivalent of the FDA, examined more than 1,000 drugs in various dosages affected by GVK’s “data manipulations” and has suggested pulling 700 off the market. You can find the full list on the EMA website; to their credit, the Europeans are being relatively transparent as the crisis develops. Not so much on this side of the pond, alas. So far from the FDA, we’ve heard precious little, even though there are drugs on the U.S. market that rely entirely on GVK’s tests. In a written statement, the FDA admitted that there were some 40-odd drugs whose approval depended upon GVK-run studies. Which ones? The agency is keeping mum, as it did with Cetero and with other similar cases. However, the agency assures us that it inspected GVK’s facility and found nothing to be concerned about; if the situation changes, “FDA will take swift and appropriate action to ensure that the drug products available to American consumers are safe and effective.”

Why does the FDA stay silent about fraud and misconduct in scientific studies of pharmaceuticals? Why would the agency allow claims that have been undermined by fraud to appear on drug labels? And why on earth would it throw up roadblocks to prevent the public, the medical community, its advisory panels, and even Congress from finding out about the extent of medical misconduct? The answers the FDA gives are fascinating—they show how an agency full of well-meaning people can do intellectual backflips to try to justify secrecy.

The most common excuse the agency gives is that exposing the details about scientific wrongdoing—naming the trials that were undermined by research misconduct, or revealing which drugs’ approvals relied upon tainted data—would compromise “confidential commercial information” that would hurt drug companies if revealed. This claim falls apart under scrutiny. The courts have ruled that when information is provided by companies involuntarily, such as the information that an FDA inspector finds, “commercial confidential information” refers to proprietary material that causes substantial, specific harm when it falls into the hands of a competitor. It doesn’t cover embarrassing peccadilloes—or misconduct that might cause bad publicity when word gets out.

Another excuse I’ve heard from the FDA is that it doesn’t want to confuse the public by telling us about problems, especially when, in the FDA’s judgment, the misconduct doesn’t pose an immediate risk to public health. For example, when my colleague and I asked the director of FDA’s Center for Drug Evaluation and Research why the agency wouldn’t name the drugs affected by the Cetero fraud, she told us that the matter “did not rise to the level where the public should be notified. We felt it would result in misunderstanding and inappropriate actions.” But even the most paternalistic philosophy of public health can’t explain why the FDA would allow drug companies to put data on its labels that the agency knows are worthless, or to fail to flag bioequivalence problems in a publication that is specifically designed for the purpose of flagging those very problems.

The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials. Yet, over and over again, the agency has proven itself willing to keep scientists, doctors, and the public in the dark about incidents when those scientific trials turn out to be less than reputable. It does so not only by passive silence, but by active deception. And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate. We can no longer hope that the situation will get better without firm action from the legislature.

The FDA wants you to take it on faith that its officials have the public’s best interest at heart. Justification through faith alone might be just fine as a religious doctrine, but it’s not a good foundation for ensuring the safety and effectiveness of our drugs. After all, the whole point of science-based medicine is to keep us from having to make a leap of faith every time we swallow a pill.

National Adult Immunization Plan –DRAFT ~ February 5, 2015

National Adult Immunization Program (NAIP) Draft

http://www.hhs.gov/nvpo/national_adult_immunization_plan_draft.pdf

U.S. Government Moves on Adult Vaccination Plan

Vaccination is considered one of the most important public health achievements of the 20th century and continues to offer great promise in the 21st century. Vaccines save lives and improve the quality of life by preventing serious infectious diseases and their consequences. However, the benefits of vaccination are not realized equally across the U.S.population. Adult vaccination rates remain low in the United States, and significant racial and ethnic disparities also exist.

The NAIP is intended to facilitate coordinated action by federal and nonfederal partners to protect public health and achieve optimal prevention of infectious diseases and their consequences through vaccination of adults. The NAIP includes indicators to draw attention to and track progress against core goals. These indicators will measure progress against set standards and inform future implementation and quality improvement efforts.

The plan establishes four key goals, each of which is supported by objectives and strategies to guide implementation through 2020:

Goal 1: Strengthen the adult immunization infrastructure.

Goal 2: Improve access to adult vaccines.

Goal 3: Increase community demand for adult immunizations.

Goal 4: Foster innovation in adult vaccine development and vaccination-related technologies.

Achieving the goals of the NAIP is facilitated by agreement on plan priorities and coordination of the wide range of programs that support them. The Assistant Secretary for Health serves as the director of the National Vaccine Program and will lead the NAIP and its implementation. In support of this mission, NVPO will facilitate collaboration and coordinate the monitoring of progress for the NAIP.

Proposed Forced Adult Vaccinations Now Being Considered at Federal Levels. 2.20.15

http://www.activistpost.com/2015/02/forced-adult-vaccinations-at-federal.html

U.S. HHS is Going for More Vaccinations during Pregnancy, Employer-enforced adult vaccination requirements, and, probably, Faith-based groups to uptake vaccinations

Anthony Freda Art

Catherine J. Frompovich
Activist Post

The U.S. Health and Human Services published a 46-page draft proposal and notice in the Federal Register recently regarding more mandated vaccines for adults, and especially pregnant females; employer-enforced adult vaccinations; and probably for getting faith-based groups to uptake and not oppose vaccines/vaccinations.

There is an open public comment period that ends March 9, 2015, for consumers to register their comments, etc. per instructions at this website.

How to file your comments

Electronic responses are preferred and may be addressed to: Rebecca.Fish@hhs.gov.

or

Written responses should be addressed to: National Vaccine Program Office, U.S. Department of Health and Human Services, 200 Independence Avenue SW., Room 733G, Washington, DC 20201. Attn: HHS Adult Immunization c/o Rebecca Fish. The opening paragraph of the Executive Summary of the “National Adult Immunization Plan” draft dated February 5, 2015 says,
Vaccination is considered one of the most important public health achievements of the 20th century and continues to offer great promise in the 21st century. Vaccines save lives and improve the quality of life by preventing serious infectious diseases and their consequences. However, the benefits of vaccination are not realized equally across the U.S. population. Adult vaccination rates remain low in the United States, and significant racial and ethnic disparities also exist. [1]

 

Probably, nothing is more blatantly ridiculous and scientifically incorrect than the very first sentence. Infectious disease after disease waned to extremely low levels of almost no infection and contraction rates numerous years before 20th century vaccines were even invented. This website contains more than two dozen charts and graphs indicating those documented historical facts.

However, vaccine makers unabashedly take credit for something that has become more of a health problem than a scientific advancement, in my opinion. All vaccines are super-saturated with horrendous neurotoxins and other toxic chemicals, non-human animal-source DNA, unknown viruses, fetal cell lines—aka diploid cells, and mycoplasmas, plus other ‘ingredients’—probably genetically-engineered-nanoparticles, which I discuss in detail in my 2013 book Vaccination Voodoo, What YOU Don’t Know About Vaccines.

Readers may want to know/have the peer-review published science papers cited in the book in order to corroborate damage vaccines and their ingredients cause, as part of their comments to the above HHS request.

Apparently and according to the HHS’s National Vaccine Plan (NVP),
While the NVP provides a vision for improving protection from vaccine-preventable diseases across the lifespan, vaccination coverage levels among adults are not on track to meet Healthy People 2020 targets. The National Vaccine Advisory Committee and numerous stakeholder groups have emphasized the need for focused attention on adult vaccines and vaccination. That’s what the new Federal Register publication is all about! Apparently, the feds want adults to get as many vaccines as MDs are pumping into children.

Furthermore,
The NAIP [National Adult Immunization Plan] is a five-year national plan. As a national plan, it will require engagement from a wide range of stakeholders to achieve its full vision. The plan emphasizes collaboration and prioritization of efforts that will have the greatest impact. The NAIP also aims to leverage the unique opportunity presented by the implementation of the Affordable Care Act. [Also known as “ObamaCare”] There are four key goals they want to establish by 2020 with the NAIP:
Goal 1: Strengthen [obviously mandate and enforce] the adult immunization infrastructure. Goal 2: Improve access to adult vaccines. [Have MDs hound adults to take vaccines like they do parents about kids’ vaccines.] Goal 3: Increase community demand for adult immunizations. [An interesting remark?] Goal 4: Foster innovation [What does that mean and can innovation include more toxins in vaccines than there are now? Could that mean nanoparticles or GMOs?] in adult vaccine development and vaccination-related technologies. [Technologies like getting vaccine patches or embedded RFID chips containing vaccines?] According to the draft report, the following vaccines probably are being mandated for adults:
The Centers for Disease Control and Prevention (CDC) estimates that among US adults each year there are roughly 40,000 cases and 4,000 deaths attributable to invasive pneumococcal disease, between 3,000 and 50,000 deaths [see facts below] due to seasonal influenza, 9,000 cases of pertussis, approximately 3,000 cases of acute hepatitis B, and about one million cases of herpes zoster. Adults have also been affected in recent outbreaks of other vaccine-preventable diseases such as measles. With the aging of the U.S. population, the public health impact of vaccine-preventable diseases and their complications in adults is likely to grow. The diminishing function of the aging immune system reduces the immune response to vaccination and underscores the need to develop more effective products for older adults. [CJF emphasis added] Facts about seasonal influenza:
On their own website, the CDC states that flu deaths between 1976 and 2006 ranged from a low of 3,000 people to a high of 49,000. But they also reported on their website that only 500 people died from flu in 2010. “The fact is, the outrageous claims of 3,000 to 49,000 deaths are inaccurate numbers,” says holistic family physician Dr. David Brownstein. “They are just guesswork.” [12] [CJF emphasis added] Is that a case of “Liar, liar—pants on fire?” So, how can anyone believe the CDC’s hyper- inflated statistics? So, in the draft flu deaths are up to 50,000—a nice round figure!

What neither HHS, the CDC/FDA, nor anyone associated with the vaccine industry will admit to, I contend, is this: With all the vaccines they have mandated for children since the middle 1980s—supposedly for entry into schools—they have – either accidentally or deliberately – crated reduced-functioning immune systems that cannot perform in the manner Nature and life intends and genetically programs.

Vaccine makers, in effect, have created what they think is ‘immunity’, which actually is an antigen response that, consequently, can produce inflammatory processes in the body, including the brain. An apparent end result is deficient immune systems as children grow into adulthood and older. Chronic “old-age diseases” now are plaguing young children! See “Coping with Chronic Illnesses in Childhood and Adolescence” (2012) .

“Diminishing function of the aging immune system” clearly will result in—and federally require—periodic re-vaccination in order to effectuate Big Pharma’s vaccination-produced acquired immune system, which apparently malfunctions, in my opinion. How many fully-vaccinated individuals contract the very diseases for which they are vaccinated? [11] How many children have allergies, asthma, and other immune problems? See allergy stats here. Wow!

The diminishing function of the aging immune system is an unfortunate health status that results, I think, from decades of HHS, CDC, FDA, Congress, and the media apparently believing—plus promoting—‘tobacco-science’ produced by Big Pharma, that’s propagated by corporate money and lobbyists, in my opinion.

By injecting toxins into newborn infants, then babies at 2, 4, and 6 months of age, and toddlers during the timeline when the human immune system is not fully developed—that happens for a child between two and three years of age—federal health agencies basically have ‘castrated’ almost two generations of individuals’ immune systems, thereby leaving them susceptible to diminishing functions of the immune system and contracting infectious communicable diseases—even when vaccinated—as current statistics are proving. A good percentage of those contracting communicable diseases are fully vaccinated! Now, the feds are going after “catch-up” vaccinations for adults, thinking that will help, as discussed in the Introduction of the report on page 1.

Nevertheless, this information needs to be ‘digested’:
As shown in Table 1, despite the health benefits that result from implementation of ACIP recommendations, adults continue to be vaccinated at low and variable rates. In contrast, childhood vaccination rates in the United States typically exceed 90 percent. [As a result, we have sicker kids than ever before, plus the Autism rate is 1 in 50, whereas in the late 1970s, that rate was 1 in 10,000! Furthermore, more vaccinees are contracting vaccinated-against diseases that the feds want to blame either on unvaccinated children or now, adults!] The success of childhood vaccination [Can one call so much Autism success?] can be attributed to many factors unique to pediatric vaccination, such as state laws requiring vaccination for school entry and the coordinated public health infrastructure established by the Vaccines for Children Program (VFC), a federally funded program to provide free vaccines to children who are Medicaid eligible, uninsured, underinsured, or American Indian or Alaskan Native. Another reason for the high rates of vaccination among children is that pediatricians and family physicians, the primary providers of health care and preventive health services for children, have long been committed to making immunization a core part of well-child care. [Probably, those ‘well baby’ visits after birth should be called something else because so many children become damaged after receiving vaccines. Check the VAERS reports!] On page 3 of the HHS draft, and throughout, reference is made to “stakeholder groups”. Just who are they? Furthermore, aren’t the largest “stakeholders” involved, all adults in the USA? Furthermore, I’m questioning the effect citizens’ comments and input will have, since the draft is written as something that’s a given—fait accompli! In reading the draft, readers can learn what “barriers” those stakeholder groups and researchers discuss.

It seems the Affordable Care Act [aka “ObamaCare”] has been more than influential regarding mandatory adult vaccinations. “In addition, passage of the Affordable Care Act in 2010 was an important milestone for adult vaccination in the United States. …. Furthermore, more than 71 million individuals in private plans have gained expanded access to vaccinations and other preventive services coverage without cost-sharing under the Affordable Care Act.23” [Pg.4]

This, on page 4, is rather interesting:
In 2014, NVAC published updated Standards for Adult Immunization Practice to emphasize that all providers who care for adults are responsible for assessing immunization needs at every clinical encounter, strongly recommending needed vaccines, administering recommended vaccines, and documenting receipt in a state immunization information system. The standards also instruct providers who do not vaccinate to refer adult patients to a vaccinating provider. [CJF emphasis added] And this:
Medicare beneficiaries may encounter financial barriers when accessing vaccines covered by Medicare Part D (e.g., herpes zoster vaccine and tetanus, diphtheria, and pertussis [Tdap] vaccine). Medicare Part B covers select vaccines without cost-sharing; however, cost-sharing for vaccines covered under Medicare Part D varies widely from plan to plan and may be cost-prohibitive for some patients. [Pg.4] [CJF emphasis added] However, following is an area/arena where the plan probably will encounter resistance:
The success of this plan will depend on the synergies between state, local, territorial, and tribal governments; health care providers; advocacy groups; vaccine manufacturers; academia and research organizations; payers and health plans; employers; and the general public to work together to overcome barriers and improve access to adult vaccinations. [Pp.5-6] RAND Corporation [8] was enlisted to review historic literature, interview stakeholders, and collect data to identify plan priorities and key indicators. [Pg.8] The feds apparently expect this plan to produce Healthy People by 2020. Well, if I can offer a forecast, I think it will be this: The USA will have such an overabundance of dreadfully seriously sick citizens, from all age groups, that no one will know what to do. However, senior citizens—75 and older—probably will be mandated by law to be subject to compulsory and legal euthanasia. Do you think that’s in ObamaCare too?

Pregnant females are being targeted very prominently.
In addition, NVAC provides forward-looking analyses to identify barriers and challenges to research and development of new vaccines specifically for pregnant women. [Pg.10] Interestingly, HHS submits this under Goal 1 on page 11:
Objective 1.3 Continue to analyze claims filed as part of the National Vaccine Injury Compensation Program (VICP) to identify potential causal links between vaccines and adverse events. That is nothing short of a ‘sham’, in this writer’s opinion. Causal links between vaccines have been identified in the past by CDC epidemiologists and researchers, viz.: the Simpsonwood Meeting in June of 2000—a clandestine meeting to figure out what to do with the Verstraeten study that showed the link between thimersol (ethylmercury) in vaccines and Autism.

Then, as recently as 2014, William Thompson, PhD, blew the whistle on how he fudged vaccine study papers regarding the link between vaccines and Autism.

So, can the CDC be trusted to identify causal links between vaccines and adverse events and correct them since, apparently, past history has proven they conspire to hide them?

On Page 12 under Objective 1.2, this appears:
Vaccines have a long track record of safety and effectiveness in adults… Are they kidding—seriously? Furthermore, safety tests are not performed by the FDA on vaccines! Back in 1976, the flu vaccine was involved in a memorable number of adverse events:
However, side-effects from the vaccine are thought to have caused five hundred cases of Guillain–Barré syndrome and 25 deaths. [2] According to the authors of the book The Swine Flu Affair, contracting paralyzing Guillain-Barré syndrome is 11 times greater with vaccination than without. [2]

However, there just may be a perfect example of how the CDC/FDA licenses supposedly ‘safe’ vaccines. What happened with the Rotavirus RotaShield vaccine should never have happened IF the FDA did its own safety testing with outside independent scientists, and not take manufacturers’ ‘tobacco science’, in my opinion. So how safe was that Rotavirus vaccine for children?
10/15/1999

Rotavirus: First Vaccine Withdrawn

The first vaccine for rotavirus, a common cause of severe childhood diarrheal illness, RotaShield, was licensed and recommended for routine childhood immunization in 1998. Wyeth Pharmaceuticals, however, withdrew the vaccine in 1999 due to safety concerns. Scientists associated the vaccine with a rare intestinal problem called intussusception, a potentially fatal telescoping of part of the bowel. [3] Furthermore,
According to the CDC in 1999, rotavirus was causing 20 to 40 infant deaths annually in the US when the first rotavirus vaccine, RotaShield, was introduced. It was estimated that about 50,000 hospitalizations occurred in the US because of severe diarrhea and dehydration. [9] [CJF emphasis added] Constitutional attorney Jonathan Emord tells how the FDA approved one drug in this video.  Do you believe how that drug was approved? No real studies were done!

On Page 13, we find this,
Determine the data needs to evaluate vaccine safety and monitor efficacy in pregnant women and newborns and the ability of these systems to capture relevant data, … which I think is most disconcerting insofar as, when I studied nutrition and consumer health, pregnant women were told not to take any types of medication at all—not even aspirin! [10]

Again, I’d like to make a prediction: Newborns will have more health problems than at any time in medical history! Between vaccines given to pregnant mothers, which probably will cross the placental wall, and all the ultrasound frequencies from as early as 6 to 7 weeks in pregnancy, babies surely are going to birth with more ‘fried’ brains than ever. Ultrasound/sonograms can cause cavitation in brain cells.
A rise in temperature of fetal tissue—especially since the expectant mother cannot even feel it—might not seem alarming, but temperature increases can cause significant damage to a developing fetus’s central nervous system, according to research. [4] [CJF emphasis added] Then, inject Hepatitis B vaccines within 24 hours after infants are born…OMG! Personally, as a retired healthcare professional, I’m compelled to ask, “Do they really know what they are doing?”

In the draft they talk about resolving vaccine injury claims and VEARS in several places. However, the track record at the “Vaccine Court” is less than admirable or equitable, I’d say. As of the end of fiscal 2014, there were 3,540 claims paid but 9,734 were dismissed—almost a 3 to 1 ratio of vaccine adverse events claims NOT paid. And, when that happens to you or your child, you are saddled for life with medical bills that are unimaginable! [5]

On Page 15, we read where employers will be involved in making certain adults are vaccinated.
1.6.2. Encourage employers to offer and promote adult immunization using evidence on economic impact.

[….]

The most immediate impact from an employer perspective may be with seasonal influenza immunization campaigns, but efforts here offer the possibility of expanding to other vaccines recommended for adults.

[….]

Encourage on-site, occupational health vaccination clinics and involvement of employers to increase employee vaccination rates. [Your place of employment may become a nightmare of prodding proselytization and probable jabbing with needles.] Under the topic “Increase Community Demand for Adult Immunizations,” we find that there apparently will be constant ‘badgering’ campaigns to receive vaccinations. Numerous pages about “how to” indicate that it’s going to be unavoidable, plus probably “in-your-face” too, and everywhere!

Probably, the most frightening statement, in my opinion, is found on Page 24:
One of the five goals of the NVP is to develop new and improved vaccines. First of all, there are too many vaccines now that are harmful. Furthermore, what will Pharma produce in the future when everyone will have to receive vaccines for which Big Pharma have no legal liability to produce safe vaccines or vaccines that are tested for their abilities to produce cancer, interfere with fertility/cause infertility, or cause birth defects? Currently, NO vaccines are tested for those health adverse events. Every vaccine package insert states that those tests have not been done! So, how are vaccines proven to be safe, if we don’t know if they can cause cancer, especially since they contain numerous toxic chemicals? Good question?

Here’s another prediction I’m offering: Everyone in the USA will have to get a vaccination a day! Maybe two, since there are hundreds of new vaccines in developmental pipelines from what I know.
Implementing the NAIP will require not just federal action, but also national action. [Pg.26] By 2020, the feds want 100 percent of all pharmacists administering vaccines! [Pg.29]

In the draft’s base year of 2012, only 45 percent of adults received a provider-recommended flu shot; whereas by 2020, they want 90 percent compliance! Flu vaccines apparently don’t fare very high in efficacy ratings or safety for children or adults. (Source)

When I read this on Page 31, I shouted, “WHAT?”
*Note that the published immunization schedule does not include 2014 ACIP recommendations related to the use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years. Additionally, valents in a vaccine refer to an antigen or organism for a specific disease. So, a 13-valent vaccine means 13 antigens, while the 23-valent vaccine means 23 antigens! Antigens usually are associated with aluminum in order to produce/acquire ‘an adaptive immune response’ [6]—in any combination of four formulations: Aluminum hydroxide, Aluminum hydroxyphosphate sulfate, Aluminum phosphate, and Aluminum potassium sulfate.
Vaccines may be monovalent (also called univalent) or multivalent (also called polyvalent). A monovalent vaccine is designed to immunize against a single antigen or single microorganism.[16] A multivalent or polyvalent vaccine is designed to immunize against two or more strains of the same microorganism, or against two or more microorganisms. [7] There is a lot at stake in the HHS draft regarding vaccines that needs to be considered very carefully from all angles and by everyone, I think. Many adults have acquired immunity from having contracted infectious childhood diseases and should not be vaccinated, if that’s the case. There are blood tests that can establish one’s immunity to infectious diseases—rather than risk toxic vaccine ingredients, which everyone ought to know about. I’ve listed them here:

There also are tests for polio and yellow fever.

Source of above test information is http://www.sfcdcp.org/aitcbizservices.html

Additional information about Vaccine Titer Tests appears here. http://drtenpenny.com/titer-tests/

Please don’t forget to send in your comments before March 9, 2015 to the CDC about their draft proposal for mandatory adult vaccinations. Refer to the third paragraph at the beginning of this article for submission instructions.

References:

[1] http://www.hhs.gov/nvpo/national_adult_immunization_plan_final.pdf
[2] http://en.wikipedia.org/wiki/1976_swine_flu_outbreak
[3] http://www.historyofvaccines.org/content/timelines/others#EVT_100774
[4] Miller, M.W., et al. 2002. Hyperthermic teratogenicity, thermal dose and diagnostic ultrasound during pregnancy: implications of new standards on tissue heating. Int J Hyperthermia 18(5): 361–84.
[5] http://www.hrsa.gov/vaccinecompensation/statisticsreports.html
[6] http://www.biology.arizona.edu/immunology/tutorials/immunology/page3.html
[7] http://en.wikipedia.org/wiki/Vaccine
[8] http://www.globalresearch.ca/new-world-order-insider-reveals-diabolical-secrets-of-the-rand-corporation/22473
[9] http://www.nvic.org/vaccines-and-diseases/Rotavirus.aspx
[10] http://www.drugs.com/pregnancy/aspirin.html
[11] http://www.pbs.org/newshour/updates/whos-risk-measles-maybe-think/
[12] http://www.newsmaxhealth.com/Headline/flu-shot-vaccine-dangers/2015/02/17/id/625264/

Resources:

Immunization Graphs: Natural Infectious Disease Declines; Immunization Effectiveness; and Immunization Dangers
http://drtenpenny.com/wp-content/uploads/2012/06/Decline-of-infectious-disease.pdf

National Vaccine Advisory Committee. A Pathway to Leadership for Adult Immunization: Recommendations of the National Vaccine Advisory Committee. Public Health Reports. 2012;127.

Acquired Immunity
http://www.merckmanuals.com/home/immune_disorders/biology_of_the_immune_system/acquired_immunity.html

Recommended Adult Immunization Schedule—United States—2015
http://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2014-10/adult-imm-Riley.pdf
Catherine retired from researching and writing, but felt compelled to write this article. 

Catherine J Frompovich (website) is a retired natural nutritionist who earned advanced degrees in Nutrition and Holistic Health Sciences, Certification in Orthomolecular Theory and Practice plus Paralegal Studies. Her work has been published in national and airline magazines since the early 1980s. Catherine authored numerous books on health issues along with co-authoring papers and monographs with physicians, nurses, and holistic healthcare professionals. She has been a consumer healthcare researcher 35 years and counting.

Catherine’s latest book, published October 4, 2013, is Vaccination Voodoo, What YOU Don’t Know About Vaccines, available on Amazon.com.