Category Archives: autism

2015: Vaccines, Retroviruses, DNA, and the Discovery that Destroyed Judy Mikovits’ Career

Via: Organic Lifestyle Magazine:

Judy Mikovits, PhD is a biochemist and molecular biologist with more than 33 years of experience. Internationally known, a veritable “rock star” of the scientific world, she served as the director of the lab of Antiviral Drug Mechanisms at the National Cancer Institute before directing the Cancer Biology program at EpiGenX Pharmaceuticals. She later developed the first neuroimmune institute. Her early work focused on cancer and HIV, her latest on Chronic Fatigue Syndrome and autism. She has published more than 50 peer-reviewed articles.

In 2011, she made the discovery that destroyed her career. She found that at least 30% of our vaccines are contaminated with gammaretroviruses. Not only is this contamination associated with autism and chronic fatigue syndrome, it is also associated with Parkinson’s, Lou Gehrig’s disease, and Alzheimer’s.

When she released this shocking information, she was warned by Dr. Andrew Wakefield that she would become a target, just as he had been. But she assured him that all of her work had been properly reviewed and, of course, she was safe.

She was wrong. She was threatened and told to destroy her data; she refused. She was fired, then arrested for supposedly stealing her data from her worksite. She had been facing charges and was bound by a gag order from the court for the last four years. Recently, charges were dropped and the gag order was lifted. Dr. Mikovits is now free to talk, and boy is she talking.

The retroviruses contaminating vaccines originate from mice used for research. Dr. Mikovits asks, “How many new retroviruses have we created through all the mouse research, the vaccine research, gene therapy research? More importantly, how many new diseases have we created?”

“When they destroyed all of our work, and discredited everything I or Frank Ruscetti had ever published, and arranged for the publication of my mug shot in Science, the NIH very deliberately sent the message to researchers everywhere about what would happen to any honest scientist who dared ask those important questions.”

More:

Plague: One Scientist’s Intrepid Search for the Truth about Human Retroviruses and Chronic Fatigue Syndrome (ME/CFS), Autism, and Other Diseases by Kent Heckenlively and Judy Mikovits

Retroviruses: Poorly Understood Agents of Change

World Renowned Genetics Doctor Sees Relationship Between Fetal Cells Used in Vaccines and Increasing Autism Rates

September 24, 2017 1:58 pm
Dr. Theresa Deisher
Dr. Theresa Deisher recently granted an interview with the VAXXED team to discuss, among other things, vaccines and autism. Theresa Deisher, Ph.D., is the president of Sound Choice Pharmaceutical Institute (SCPI), a cutting edge biomedical research organization. Dr. Deisher is a genetic engineer with over 20 years experience in the pharmaceutical industry, from basic human biology through clinical trials. Dr. Deisher states in her VAXXED interview that she looked at the rise in autism rates in the U.K. and its link to the MMR vaccine, originally discovered and published by Dr. Andrew Wakefield, and how the medical establishment tried to discredit Dr. Wakefield’s research. She notes that one reason given to try and discredit Dr. Wakefield’s research was that MMR vaccination rates remained steady both prior to and after the spike in autism rates in 1988. However, what she discovered that was not reported was that the manufacturer of the MMR vaccine switched from animal cells to develop cultures to human fetal cells from aborted babies in 1988. So she had one of her Ph.D. researchers investigate the matter more thoroughly, and compare autism rates to the use of human fetal cells in vaccines, and she discovered that every time fetal cells were introduced into the manufacture of vaccines, autism rates increased.
Read More…

 

Mandatory Vaccines For All; Where’s the Outrage?

Mandatory Vaccines For All; Where’s the Outrage?

vaccine

Why are they pushing the less than 1.5% of children to get mandatorially vaccinated ordered without choice, by a medical industry that ranks 38th in the world of QUALITY of care and #1 in COST of care?  Doctors get very little training on vaccines and rely on the drug pushers to inform them.

Now, since the H1N1 hype, scare, SAfeway, Drug Stores, etc. offer nearly free vaccines, schools mandatorially demand our children to be vaccinated and parents and adults are next.

What is in the vaccines, where the science that it works is completely unproven? Why all must be shot? Is there something really bad in the vaccines, like chips and illness that we aren’t being told about?

Would you really put aborted female stem cells, chicken embryo’s, formeldahyde, aluminum, etc. in your child if you knew these were just some of the ingredients???

YOUR CHILD< YOUR CHOICE

MY BODY < My Choice

And not govern (to rule) ment (mental) agency that must only use enforce-ment, will change this .

bay-area-healthcare

Image result for us rank quality of healthcare?

Mandatory Vaccines For All Coming Very Soon

What’s in Your Vaccine?

Childhood Vaccine Schedule: Where is the Science?

Americans have been carefully taught to fully trust the recommenda-tions made by medical doctors and public health officials, and many do trust without questioning. After all, we expect and want to believe that the recommendations being made by the “medical experts” are evidence-based and thoroughly tested for safety. In the case of the childhood vaccine schedule recommended by the U.S. Centers for Disease Control and Prevention (CDC) and American Academy of Pediatrics (AAP), the general…

Patent Reveals Plan To Hide Vaccines In Food Particles

“Consult Your Doctor”? Think Again!

The Agenda and You ~ Part II; Care For Chips With Your Vaccines?

Bill Gates, Vaccines & Depopulation Agenda; The Message Cannot Get Any Clearer!

The Origins of Vaccines Will Shock You!

300 GMO Vaccines in the Pipeline, CDC Adds 3 More to the Schedule

Mandatory Vaccines For All Coming Very Soon

Free Immunization Journal Seeks to Educate Parents on ALL the Facts Regarding Vaccines

Founder of CMSRI Believes That Parents Have the Right to Know ALL the Facts When it Comes to Vaccinations by Christina England Health Impact News Over the years, more and more parents have been questioning the safety and efficacy of the vast number of vaccinations being routinely recommended for children. Despite their genuine concerns, many …

Deadly Vaccines in China Getting Much Worse; 83% of all Vaccines made in China

Vaxxed Documentary Going Cross Country Tour to Awaken the Snoring about Vaccines

“Vaxxed: From Cover-Up to Catastrophe” the Most Controversial Film in America Launches a Nationwide Bus Tour on August 6th LOS ANGELES, July 27, 2016 /PRNewswire/ — Following a notable theatrical U.S. and Canadian release, the team behind America’s most controversial film, “Vaxxed: From Cover-Up to Catastrophe,” will hit the road on a nationwide bus tour starting …

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Murdered Holistic Doctors Had Discovered Autism/Cancer-Causing Enzyme Intentionally Being Added to All Vaccines

So apparently the holistic doctors who were all being killed in Florida had found out via their research that the nagalase enzyme protein is INTENTIONALLY being added to the population via immunizations. Nagalase STOPS vitamin D from binding to the Gc protein. This completely strips a human being’s body of it’s natural ability to kill cancer …

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Screw Vaccines, Check out Smart Dust Moregellon’s Read/Write Technology Wirelessed into your Nervous System!

Truth ALWAYS stranger than Fiction.  Remember Moore’s Law/Rule, Technology (both good and bad) doubles each and every year.  What we hear about vaccines is nothing compared to this invasive species borne into all through inhalation of nanoparticulate matter.  This is why halting all Geoengineering practices is so critical.

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Patent Reveals Plan To Hide Vaccines In Food Particles

A disturbing patent discovered this week reveals plans to hide vaccines within food particles without the public knowing about it. US Patent application ‘US20080044481 A1’ (“Microparticles for oral delivery”) was filed in 2005, and allows drugs and vaccines to be embedded into tiny invisible particles of food. Are we to assume the technology hasn’t yet been applied? …

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New GMO Vaccines Will Permanently Alter Human DNA

Interview With Suzanne Humphries: Dissolving Illusions (Part I)

http://www.thevaccinereaction.org/2016/01/interview-with-suzanne-humphries-dissolving-illusions-part-i/

The following is the first half of the transcript of an interview with Suzanne Humphries, MD, author of the book Dissolving Illusions: Disease, Vaccines, and The Forgotten History. The interview was conducted by Joseph Mercola, MD. Click here to read the second half of the interview.

(Dr. Mercola—DM, Suzanne Humphries—SH)

DM: Vaccines are one of the most controversial medical therapies, and it’s impossible to make an informed decision unless you know both sides of the story. In the process of knowing those both sides, the historical context is critical. Hi, this is Dr. Mercola, helping you take control of your health. To help us discover and appreciate the historical context, we have with us today Dr. Suzanne Humphries, who is a nephrologist and who has committed a large portion of her medical career to expose this history of vaccinations that you need to be aware of. Welcome and thank you for joining us today, Dr. Humphries.

SH: Thank you, Dr. Mercola.

DM: It would be best I guess for our viewers if we started with you providing us a framework and a perspective of how you first became interested in this area.

SH: Well, it was in 2009 when there were several patients that came into the hospital where I was working. They volunteered to me that they were fine until they had that vaccine. Before that, I was pretty agnostic about vaccination. I had vaccinated my dialysis patients; I, myself, was vaccinated; and I pretty much believed what I was taught in medical school.

And then I started noticing that orders are being given to my patients on the first hospital day often when they had serious diseases—inflammatory diseases, heart attacks, congestive heart failure, and one patient with cancer on chemotherapy. My patients were getting vaccinated on their first hospital day before I even saw them and the order had my name on it. This kind of alerted me that there was something going on that I had not approved of. I complained to the hospital administration about it. It was from there, it was from the resistance that I was met with that kind of ironically led me into the path that I’ve come into.

I had to research vaccination in order to meet all the arguments that I was given—that vaccines are safe and effective; that they can’t possibly be causing that much trouble; and that they have changed the face of disease in the world. Well, later, I ended up agreeing with that, but not for the same reasons that they were saying.

But it turned out that in the medical literature, there was absolutely nothing to support vaccinating an acutely ill person. At some point, they called in an expert to set me straight. The arguments that I got from the experts still were not lining up with science. They were not supporting the paradigm that they were saying. My patients were acutely ill, they had inflammatory diseases, and I didn’t want them vaccinated. I was told that I was confusing the nursing staff by discontinuing vaccines in my patients. That was kind of how it all started.

DM: Thank you for that historical perspective. I’m wondering what motivated you to write your book, Dissolving Illusions: Disease, Vaccines, and The Forgotten History, which really exposes the vast amount of deceptive information that’s really being given about vaccines.

SH: Well, it started with the hostility that I received simply by not agreeing that vaccines were safe and effective, and could be given to virtually anybody regardless of how sick they were. There were arguments tossed at me from on high—that smallpox was eradicated by vaccination, that, polio was eradicated at least in this hemisphere by vaccination, and that pretty much it was God’s gift to mankind. I actually did get that by diffusion through my medical training. I never critically thought about it. I really never had a reason to or I didn’t think I had the reason to.

That research, just to counter the arguments that I was being met with, to justify vaccinating sick patients on their first hospital day, was what got me to start researching smallpox and polio. Even that had actually nothing to do on what was happening in my sphere.

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.

Parents Speak Out; Vaccines and Autism #hearthiswell

On 8/27/14, CDC Scientist Bill Thompson issued a statement addressing his regret that he and his co-authors omitted “statistically significant information” in a 2004 study on the MMR vaccine causing autism.

CNN reporter Deborah Goldschmidt then published an article which embedded a CNN video where health correspondent Elizabeth Cohen states that within all of the dangerous side-effects of vaccines, autism is not listed. She then rephrased saying, “Some people don’t hear this well: vaccines do not cause autism.”

Outraged that CNN would choose to embed such a statement within Dr. Thompson’s confession that he and his co-authors had omitted evidence that African American males were at increased risk for autism from journal publication, autism parents across the country and across the globe responded to a call from the Autism Media Channel. These parents addressed the CNN correspondent directly, informing her that in their own families, vaccines had, in fact, caused autism.

 

 

National Adult Immunization Plan –DRAFT ~ February 5, 2015

National Adult Immunization Program (NAIP) Draft

Click to access 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.