Children should not be vaccinated by any health care provider for any reason without the voluntary, informed consent of their parents. Period. HB 212, by Rep. Toni Rose ((D), D-110, Dallas) circumvents federal and state parental rights and consumer protection laws by allowing a minor child 14 years of age and older in the Texas Juvenile Justice System to consent to vaccination on their own without their parent.
It also allows for a health care provider to consent to vaccination for the child if a parent has previously consented to any medical treatment not specific to vaccination. Unless the health care provider has “actual knowledge” that a parent has refused to give consent for a particular vaccine in the past, the doctor only has to make a “reasonable” attempt to contact the parent before he or she can shift the decision making to a minor child and themselves.
The bill also puts the responsibility on the minor child to reveal personal and family vaccine reaction and medical history to the vaccine administrator while protecting the vaccine administrator from liability for any harm caused by vaccinating a child without parental consent.
In this nation of over 300 million, a little over a hundred cases of measles have been reported with no deaths. Some epidemic. Why is everyone so concerned? How many epidemic scares have we seen in the past few years? Both swine flu scares, SARS, bird flu, H1N1 flu, the Ebola scare and wasn’t heterosexual AIDS predicted to wipe out a quarter of the earth’s population? And this is only a partial list! As George Carlin once said, “Americans panic easily.”
But who can blame us when the “experts” say terrible things are going to happen and the media doesn’t give the other side of a story? The media merely parrots the official medical party line and even ignores and mocks those with opposing views. The fact that they’ve been wrong every time doesn’t matter; people still freak out when told, “It’s coming and it’s gonna be bad this time.”
What exactly is measles?
Measles is a short-lived viral infection that begins with a fever that lasts for a couple of days, followed by a cough, runny nose and conjunctivitis (pink eye). A rash starts on the face, hairline and upper neck, spreads down the back and trunk, and extends to the extremities. After about 5 days, the rash fades.
How dangerous is measles?
Measles is a mild and harmless disease that leaves a stronger, healthier child in its wake; most adults today who were born before 1965 got measles and have lifelong immunity as a result. Serious problems from measles are very, very rare. This, by the way, was standard medical policy; measles was just a rite of passage. It changed when the measles vaccine came on the market in the 1960s. Suddenly this mild, beneficial rite of passage became a deadly disease.
Some MDs still don’t buy the hype. As Jay Gordon, MD, former UCLA Medical Center pediatrician recently said:
This measles outbreak does not pose a great risk to a healthy child and quite frankly I don’t think it poses any risk to a healthy child.
How deadly is measles compared to the measles shot?
Dr. Anne Schuchat, director of CDC’s National Center for Immunization and Respiratory Diseases, in an Associated Press interview in 2014 stated that there have been no measles deaths in the US since 2003. (Source, Source)
Now let’s look at this measles vaccine
“Pediatricians continue to defend vaccination to the death. The question parents should be asking is, ‘Whose death?’” Robert Mendelsohn, MD
Another government reporting agency, The National Vaccine Adverse Event Reporting System (VAERS), reports 108 children died from the measles vaccine during a ten year period. But that may be a fraction of the real number because MDs often do not report vaccine injuries.
Death certificates, usually filled out by MDs, very rarely mention vaccination as the cause of death. They may write encephalitis or brain inflammation rather than vaccination even though vaccines can cause brain inflammation) on the death certificate. We don’t know the real number of vaccine injuries and deaths. But they are most likely much greater than what VAERS reports due to underreporting.
According to Dr. David Kessler, former head of the Food and Drug Administration, “Only about 1 percent of serious events [adverse drug reactions] are reported to the FDA.” Kessler DA, Natanblut S, Kennedy D. et al. Introducing MEDWatch A New Approach to Reporting Medication and Device Adverse Effects and Product Problems. JAMA. 1993;269(21):2765-2768.
We don’t know how many vaccine injuries and deaths there are but if we apply the above underreporting number to vaccine injuries then possibly as many as 10,800 children might have been harmed or killed by the measles vaccine during the period that at most four died from measles.
In addition two serious diseases rarely found in the non-vaccinated:
Atypical measles occurs only in the vaccinated and can be fatal. (Source)
Atypical measles was initially thought to occur only in those who received the killed measles vaccine, but several investigators have reported this illness in children who had been vaccinated only with the live measles vaccine.
Nichols EM. Atypical measles: a continuing problem. Am J Public Health. 1979;69(2):160-162 (Source)
The measles vaccine can also cause subacute sclerosing panencephalitis (SSPE), which is 100% fatal, in a very small number of children.
SSPE is a progressive neurological disorder of children and young adults that affects the central nervous system (CNS). It is a slow, but persistent, viral infection caused by defective measles virus.(Source)
Measles amongst the non-vaccinated?
The Amish are a religious community the vast majority of which are not vaccinated. They reported not a single case of measles between 1970 and 1987. Sutter RW, Markowitz LE, Bennetch JM, Morris W, Zell ER, Preblud SR. Measles among the Amish: a comparative study of measles severity in primary and secondary cases in households. J Infect Dis. 1991 Jan;163(1):12-6. While the local highly‐vaccinated communities still reported epidemics every 2‐3 year. Based on this experience measles appears to circulate more amongst the vaccinated than the non-vaccinated.
However useful or safe properly manufactured, distributed and administered vaccines might be in theory — and the jury is still out on the issues of safety and efficacy for a number of vaccines — vaccine experts have repeatedly reversed themselves about the safety or effectiveness of vaccines they have previously sworn were safe. Science often provides an imperfect answer.
Properly tested and licensed vaccines were later found to cause injury and death and were stopped by vaccines authorities. A 1993 MMR vaccine was found to cause mumps and encephalitis Sawada eta. 1993; Lancet 342 (7 August): 371 the Edmondson-Zagreb measles vaccine was stopped because children had an increased rick of death from other diseases years after vaccination Weiss, R. 1992. Measles battle loses potent weapon.Science; 258 (23 October): 546-547 the pertussis (whooping cough) vaccine was boycotted by doctors in Japan after 57 severe reactions and 37 deaths. The Japanese government switched to a different vaccine Sato Y, et al. 1984. Development of a pertussis component vaccine n Japan. Lancet; 1: 122-126 and Noble GR et al. 1987 Acellular and whole-cell pertussis vaccines injapan:report of a visit by US scientists. J Amer Med Ass; 257: 1351-1356.
In 2010, the Rotarix (rotavirus) vaccine was recalled because it was contaminated with DNA from pig virus. It was given to one million U.S. children, and about 30 million worldwide. A measles vaccine was also found to contain low levels of the retrovirus avian leukosis virus, and Rotateq, Merck’s rotavirus vaccine, was found to contain a virus similar to simian (monkey) retrovirus. (Source)
In 1955 hundreds of babies and adults came down with polio after they were vaccinated with the Salk vaccine. The vaccination program was temporarily halted. Eventually the Salk vaccine was replaced with the Sabin vaccine that was found to cause polio and was then changed back to the Salk vaccine.
People have a right to choose because the science is never absolute.
Pharmaceutical companies have lost millions due to dishonest practices. In 8 years (2004-2001) there were 20 pharmaceutical company settlements in the $345 million to $3 billion range. Criminal fines in the $100’s of millions are common, and have been as high as $1 billion (Pfizer 2009, GlaxoSmithKline 2012). This is routine business practice. List of largest pharmaceutical settlements (2004 – 2012), Wikipedia
Merck, manufacturer of the mumps vaccine, is going to trial in two separate lawsuits for allegedly falsifying the efficacy rate of its mumps vaccine. One suit was filed by former employee-whistleblowers, the other by pharmaceutical competitors. Lawsuits claiming Merck lied about mumps vaccine efficacy headed to trial, Fierce Vaccines, September 9, 2014.
Not only are vaccines dangerous, they are also ineffective
Diseases have occurred in fully vaccinated populations. Here is a sampling of recent headlines:
Immunized People Getting Whooping Cough
Vaccine Failure — Over 1000 Got Mumps in NY in Last Six Months
Over 98% were vaccinated in measles epidemic
Hersh BS, Markowitz LE et al. A measles outbreak at a college with a prematriculation immunization requirement. Am J Public Health. 1991;81(3):360-364.
NY measles outbreak: 90% were vaccinated.
Ohio mumps outbreak: 97% vaccinated.
Pertussis outbreak: 91% fully vaccinated.
99% vaccinated in flu epidemic
Did vaccines eradicate measles?
Deaths from measles, scarlet fever, typhoid, whooping cough, and diphtheria were down up to 99% BEFORE vaccination. The vaccines did nothing to increase the downward trend and may have kept the diseases from disappearing due to “viral shedding.”(Source)
The measles shot can only be said to work if it worked backwards in time. After the shot came out the drop in measles deaths stabilized.
What caused the great drop? Clean water, sanitation, indoor toilets, hot and cold running water, less crowding and improved living conditions resulted in better resistance to disease. Medicine had comparatively little to do with it. You can’t cure an epidemic by throwing chemicals at it. By the way, there was no vaccine for scarlet fever yet deaths dropped just the same. Why? More proof that factors other than vaccination had the major role in decreasing deaths from childhood disease.
Autism and measles vaccine– coincidence?
Who are you going to believe, me or your own eyes? – Chico Marx in Duck Soup (movie)
Some medical experts say that they have proven that the measles vaccine does not cause autism yet mothers across America and around the world report a different experience.
A mother brings her healthy child to the pediatrician for a measles shot. An hysterical mother calls soon afterwards saying something is wrong. Perhaps the child had a seizure shortly after the visit or spiked a high fever, slept for an entire day, stopped speaking, forgot his letters, no longer makes eye contact, is spinning in circles, is screaming and is no longer the child he was a few days ago. Sometimes the child dies (referred to as SIDS or crib death).
Such events are reported repeatedly by mothers around the world after various vaccinations.
In fact since 1987 the federal gov’t has paid over $3 billion to families whose child has died or been maimed for life after such an experience.
“It’s just a coincidence,” the pediatrician says.
But when he gets the same call about another child in his practice what does he say then? “These vaccines are safe, the government says so”?
But when another, and another and another mother gives a similar story asking, “What did you do to my child?” How many times will the pediatrician say, “It’s just a coincidence”?
This happens over and over – when do you allow parents to stop the shots? Who is right, the mother or the doctor? A medical researcher once told me, “Always go with the mother’s observation. She knows her child best.”
The government says your child must be vaccinated, I say, let the mother choose.
Even today the vaccination-mandate zealots belittle and dismiss the concerns of all parents by questioning their intelligence. (Source)
Today’s medical denial of the vaccine-autism link reminds me of a scene in the Marx Brothers’ movie Duck Soup where Chico is caught red-handed dallying with a pretty young woman. He denies it adding, “Who are you going to believe, me or your own eyes?”
Government authorities say they are confident they have proven that no link exists. Is this enough to force parents to vaccinate their children?
Autism affects as many as 1 in 50 children but a few decades ago (when vaccines were few) autism rates were 1 in 10,000. When will they stop the shots? When it’s one in two?
We should note an interesting phenomenon: immigrants who come to the US from native lands that have never known autism (they don’t even have a word for it) suddenly find their American-born (and vaccinated) children develop autism and other neurological disorders. (Source)
Say no to drugs
Vaccines are unsafe and ineffective. It’s time we simply said no to drugs – especially these drugs. They are creating a generation of sick children and bankrupting their parents.
When I was in a large elementary school in New York I remember seeing three or four kids in a special class who were brain injured or had birth injuries. They were few. Years later entire classrooms would be devoted to brain injured (autistic and otherwise) children. Now there are entire schools for these children.
Are we so sure that vaccines do not contribute to at least some of this damage to eliminate a parent’s right to choose not to expose their children to the possibility that vaccines might contribute to that damage?
Despite the billions spent on media hype and corporate research science can never prove a negative. Repeatedly experts have told us they know the truth, to change their minds later. No studies trying to placate an increasingly concerned public, no media hype designed to humiliate parental vaccine doubters can stop vaccine-damaged kids from coming whatever the source. For many patients the vaccine decision comes down to a child having a week lost from school or the possibility of a lifetime lost.
Sadly, autism is just the tip of the iceberg. We have a generation of chronically ill children. Today one in six children has neurodevelopmental disorders, one in eleven has asthma, one in twelve has food allergies, and one in 400 has diabetes. Let’s not forget ADD, ADHD, dyslexia, “processing disorders,” vision and hearing disorders, digestive disorders, immune system disorders and more. It’s getting worse.
For how long will parents be denied the truth? They know their child. They even have videos of their child before and after the shot – it’s not the same child. Whatever shots are doing they are not preventing children from getting sicker. They are not preventing autism and the growing number of health problems faced by children.
As Viera Scheibner, Ph.D. writes in British Medical Journal Rapid Response 24 March 2005:
The fact is that there IS evidence of the causal link between MMR and autism – perhaps the best one is that the autistic children are the living proof documented by many of their parents’ videos ‘before’ and ‘after’… However not just is there an obvious temporal association but all the criteria for establishing a causal link set by “the father of medical statistics”, Bradford Hill (1969) “The environment and disease: association or causation?”, Proc Royal Soc Med:295-300 are met, including very importantly, biological plausibility.
There is a debate on this issue – why does the media, the pharmaceutical companies and many medical doctors ignore this and assume the matter is settled?
Much research links autism and vaccination. Here is one link citing 97 research papers connecting autism and vaccines. At the least there is controversy so why not err on the side of caution?
Why should government strong-arm tactics and media hype override what parents believe on their own experience and scientists find in study after study?
While it may not be conclusive, any argument that says, “We have proven that there is no link” is also not conclusive. Why should the government prevent parents from erring on the side of caution?
Why do they call them childhood diseases?
Why do they call measles, mumps, chicken pox and the rest childhood diseases?
This is not a trick question. The answer is simple; they were contracted during childhood. Not as a baby, not as an adult, teenager, or – but a child usually around ages 4,5,6,7. It happens after you’ve used up the immunity you got from your mother (known as passive immunity).
When I was a kid almost nobody got measles in high school. You rarely if ever heard of an infant getting measles. But now newborns, infants, babies, teenagers and adults get measles and other “childhood” diseases. Why aren’t they childhood diseases like they used to be? It’s because vaccination has altered the natural immunity cycles.
Some research reveals that childhood vaccination appears to upset the age of occurrence of disease and is responsible for babies and adults getting these diseases – ages when they are more dangerous and even fatal. (Source) It is important for people to get measles when they are children. Not before and not after.
Vaccination disturbs this natural order of life.
California Measles Surveillance Update February 13, 2015
Since December 2014, there have been 113 confirmed measles cases reported in California residents.
Table 3. Age distribution of confirmed measles cases. (Source)
As you can see from the above chart the majority of those that got the “childhood disease” measles were not children. They were infants and adults. Why?
What changed things?
When little girls normally got measles and other childhood diseases they developed full immunity and years later they were able to pass on that immunity to their unborn child. Their baby is born protected against measles and lots of other diseases from the protection the mother passes on during pregnancy through the placenta (hence the term “transplacental” immunity). Breastfeeding also permits the baby to obtain additional immune factors from the mother.
Vaccinations interfere with transplacental immunity
One unanswered question is: when a little girl is vaccinated is she not able to develop full natural immunity? She passes on less immune factors to her unborn child. It has been shown that breastfed infants of vaccinated mothers have nearly three times the risk of measles infection compared to those of naturally immune mothers. In 1963 the measles vaccine was introduced and the following was discovered:
Infants whose mothers were born after 1963 had a measles attack rate of 33%, compared to 12% for infants of older mothers. Infants whose mothers were born after 1963 are more susceptible to measles than are infants of older mothers. An increasing proportion of infants born in the United States may be susceptible to measles. . . Papania M. et al., Increased susceptibility to measles in infants in the United States, Pediatrics, November 1999, Vol. 1045, No. 5, e59, pp. 1-6.
Are babies today getting measles because their mothers were vaccinated and stopped long-term breastfeeding?
Antibody levels are lower in women young enough to have been immunized by vaccination than older women”.
Lennon JL and Black FL. Maternally derived measles immunity in era of vaccine-protected mothers. J Pediatrics. 108(1):n671-676.
Is that why newborns and infants today can develop what used to be “childhood” diseases? Vaccine mandates are imposed upon millions of children without addressing this question.
In addition to live and killed bacteria, viruses and their toxins, children are injected with some of the most lethal poisons known: formaldehyde, mercury, aluminum, phenol (carbolic acid), borax (ant killer), ethylene glycol (antifreeze), dye, acetone (nail polish remover), latex, MSG, glycerol, polysorbate 80/20, sorbitol, monkey, cow, chick, pig, sheep and dog tissues and cells (may be contaminated with animal viruses), gelatin, casein, fragments of human fetus cells, human viruses, antibiotics, genetically modified yeast, animal, bacterial and viral DNA (may affect recipient’s DNA) – all of these substances are contained in one or more vaccines.
It is scientifically established that mercury poisons the nervous system Vimy MJ, Lorscheider FL. Faculty of Medicine, Univ. Of Calgary, July 1991. (Study findings) & J. Trace Elem. Exper. Med. 1990;3:111-123.] in addition research also reveals that the aluminum in vaccines may be as poisonous as mercury. Shaw C, Petrik MS. Aluminum hydroxide injections lead to motor deficits and motor neuron degeneration. J Inorg Biochem. 2009;103(11):1555.
While mercury is not in the MMR shot even more significant is that the synergistic effect of adding many of the vaccine’s ingredients together have not been studied in children. We really don’t know what the chemicals we are putting into children does to them.
More and more vaccines are recommended and mandated (101 vaccines in multiple doses by the time a child is child age (CDC recommended vaccination schedule 2015) and yet the safety of the entire vaccine schedule has not been studied:
It is indisputable that the vaccination schedule has never been tested for safety in its entirety, or in the way that it is administered. In other words, while the government renews, licenses, and compels individual vaccines, it does not test – or require vaccine makes to test – the safety and efficacy of vaccines given simultaneously or the cumulative effects of multiple vaccines.
– Allen Tate, The Greater Good. Chapter Ten. Vaccine Epidemic Edited by Habakus and Holland p.83 Skyhorse Publishing: New york 2011.
One expert’s concern reflects those of others:
What if it were true that the way we now vaccinate our children causes more death, chronic disease, and disability than it prevents in America?
– Judy Converse, MPH, RD, LD
On a personal note
My work investigating the issue of vaccination reached a new level of clinical insight after developing Koren Specific Technique; a healthcare protocol used to determine if a patient has toxic, emotional or structural stress causing or contributing to their problems. I consistently found that autistic children revealed greater toxicity than non-vaccinated children.
Childhood diseases are good for children
Finally, the traditional hygienic school of health must be addressed because lost in the argument about measles is the fact that Infectious diseases of childhood are good for the overall health of the child and society.
The hygienic school is a long-standing approach towards health that sees the body acting intelligently and that symptoms serve a purpose. By suppressing symptoms we interfere with body function and drive disease deeper.
The child experiences physical and mental growth spurts following a childhood infectious disease. That is noticed in cultures all over the world. For example, in India measles is referred to as “visitation from a goddess.” As the medical historian Harris Coulter, PhD writes:
Contracting and overcoming childhood diseases are part of a developmental process that actually helps develop a healthy, robust, adult immune system able to meet the challenges that inevitable encounters with viruses and bacteria will present later on.
– Coulter HL. Vaccination, Social Violence and Criminality: The Medical Assault on the American Brain. Washington, DC: Center for Empirical Medicine. 1990.
That may include protection from cancer:
The study consistently revealed a lower cancer risk for patients with a history of febrile infectious childhood diseases.
Albonico HU, Braker HU, Husler J. Febrile infectious childhood diseases in the history of cancer patients and matched controls. Medical Hypotheses.1998;51(4):315-320.
Others have observed the link between cancer and vaccinations.
I am convinced that the increase of cancer is due to vaccination.
– Forbes Laurie, MD, Medical Director of the Metropolitan Cancer Hospital, London. Quoted: Vaccines, Are They Really Safe and Effective? by Neil Miller
The most frequent disposing condition for cancerous development is … vaccination and re-vaccination.
– Dennis Turnbull, MD (30 years cancer researcher) Quoted: Vaccines, Are They Really Safe and Effective? by Neil Miller
The Australian vaccine researcher Vera Scheibner, PhD writes:
There is no need to protect children from contracting infectious diseases of childhood. These diseases are there to prime and mature their immune system … chronic ill-health, colds, otitis media, and upper and lower respiratory tract diseases are well-documented in vaccinated children…. A well-nourished child will go through rubella, whooping cough, chicken pox and the rest with flying colors.
– Scheibner V. Immunization: The Medical Assault on the Immune System. Blackheath, Australia: Author,1993; xxii.
A logical person, reading the above, would take their child to a measles party and never give the measles vaccine to them. But with vaccination we’re usually dealing with emotion, not logic. We’re dealing with fear mongering from the medical profession and the media. Hence the uproar over a mild condition that is ultimately a blessing in disguise.
The vaccine-mandate zealots move forwards with more and more vaccines to be given to our children (and adults) without addressing these very important questions – questions that might have life or death significance.
What should we do about measles epidemics?
The vaccine-mandate zealots believe they have the facts, all the facts, and nothing but the facts. However the reality is that they are often mistaken.
Among mistakes made about vaccines in the past was that measles would be completely eradicated in 1982. Hinman AR, 1979. The opportunity and obligation to eliminate measles from the United States. J Am Med Ass; 242 (11): 1157-1162
And that it was eradicated in the US in 2000. This is from the US Centers for Disease Control http://www.cdc.gov/measles/about/faqs.html
Q: Has measles been eliminated from the United States?
A: Yes. In 2000, the United States declared that measles was eliminated from this country. The United States was able to eliminate measles because it has a highly effective measles vaccine, a strong vaccination program that achieves high vaccine coverage in children and a strong public health system for detecting and responding to measles cases and outbreaks.
Every 2-3 years, there is an upsurge of measles irrespective of vaccination compliance.
Robertson SE, Markowitz LE, Dini EF, and Orenstein WA. 1992. A million dollar measles outbreak: epidemiology, risk factors, and selective revaccination strategy. Publ Health Reports; 197 (1): 24-31. See more here.
How many children must die, be crippled physically and mentally and live lost lives before we recognize what we have done? In our worship of technology when will we recognize our hubris and realize that we are not God? We do not know enough to justify mandating 101 vaccinations from birth, for every single child.
What should we do about measles epidemics? We must work with nature. Since measles returns cyclically irrespective of vaccination rates, returning to traditional healing wisdom will return us to a time when autism, allergies, asthma, diabetes and other illnesses seen so often in children today will once again be rare or non-existent. That is what led Dr. Robert Mendelsohn, the famous pediatrician and anti-vaccination campaigner to say, “One grandmother is worth two MDs.”
A sick child needs love, nourishment, comfort and support while they are going through a healing crisis no matter what the cause. Natural, non-suppressive healthcare systems such as chiropractic, homeopathy, naturopathy, herbalism, Chinese Medicine, Indian Medicine and many other “natural” systems work with the body.
Researchers, medical doctors and health educators need to remember our place in nature, acknowledge our limitations and learn some humility. In our struggle to “conquer” disease we have unleashed an epidemic of chronically ill children who would have been far better had we not interfered with natural diseases and instead worked with the natural cycles of life; recognizing that the wisdom that permeates nature is wiser than us all.
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.
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.
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.
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.