Why is Autism on the Rise?

I have written several articles healthcare issues. A series of links have been provided at the bottom of this article for your convenience.

Supposedly research has ruled out vaccines as a cause of autism. In an effort to be fair, I will include this article posted in the NY Times newspaper. The article is entitled “Research Finds Vaccines Are Not Behind the Rise in Autism. So What Is?” Despite this article I want to put this out there. Nothing will change my mind on the matter. I believe Autism is in fact caused by childhood vaccinations. Before I discuss the research results, I want to include a brief history of vaccines in the US. This will help the rerader to see the growing trend of childhood vaccinations.

First vaccines

Edward Jenner was the first to test a method to protect against smallpox in a scientific manner. He did his study in 1796, and although he did not invent this method, he is often considered the father of vaccines because of his scientific approach that proved the method worked.

The method Jenner tested involved taking material from a blister of someone infected with cowpox and inoculating it into another person’s skin; this was called arm-to-arm inoculation. However, by the late 1940s, scientific knowledge had developed enough, so that large-scale vaccine production was possible and disease control efforts could begin in earnest.

The next routinely recommended vaccines were developed early in the 20th century. These included vaccines that protect against pertussis (1914), diphtheria (1926), and tetanus (1938). These three vaccines were combined in 1948 and given as the DTP vaccine.

Late 1940s | Recommended Vaccines

Smallpox
Diphtheria*
Tetanus*
Pertussis*
* Given in combination as DTP

The vaccine everyone was waiting for — polio vaccine

Parents were scared of the polio epidemics that occurred each summer; they kept their children away from swimming pools, sent them to stay with relatives in the country, and clamored for an understanding of the spread of polio. They waited for a vaccine, closely following vaccine trials and sending dimes to the White House to help the cause. When the polio vaccine was licensed in 1955, the country celebrated, and Jonas Salk, its inventor, became an overnight hero.

Late 1950s | Recommended Vaccines

Smallpox
Diphtheria*
Tetanus*
Pertussis*
Polio (IPV)
* Given in combination as DTP

More vaccines followed in the 1960s — measles, mumps and rubella

In 1963, the measles vaccine was developed, and by the late 1960s, vaccines were also available to protect against mumps (1967) and rubella (1969). These three vaccines were combined into the MMR vaccine by Dr. Maurice Hilleman in 1971.

Late 1960s | Recommended Vaccines

Smallpox
Diphtheria*
Tetanus*
Pertussis*
Polio (OPV)
Measles
Mumps
Rubella
* Given in combination as DTP

The 1970s — vaccine success

During the 1970s, one vaccine was eliminated. Because of successful eradication efforts, the smallpox vaccine was no longer recommended for use after 1972. While vaccine research continued, new vaccines were not introduced during the 1970s.

Late 1970s | Recommended Vaccines

Diphtheria*
Tetanus*
Pertussis*
Polio (OPV)
Measles**
Mumps**
Rubella**
* Given in combination as DTP
** Given in combination as MMR

Vaccine development in the 1980s — hepatitis B and Haemophilus influenzae type b

The vaccine for Haemophilus influenzae type b was licensed in 1985 and placed on the recommended schedule in 1989. When the schedule was published again in 1994, the hepatitis B vaccine had been added.

The hepatitis B vaccine was not new, as it had been licensed in 1981 and recommended for high-risk groups such as infants whose mothers were hepatitis B surface antigen positive, healthcare workers, intravenous drug users, homosexual men and people with multiple sexual partners. However, immunization of these groups didn’t effectively stop transmission of hepatitis B virus. That’s because about one-third of patients with acute disease were not in identifiable risk groups. The change of recommendation to immunize all infants in 1991 was the result of these failed attempts to control hepatitis B by only immunizing high-risk groups. Following this recommendation, hepatitis B disease was virtually eliminated in children less than 18 years of age in the United States.

1985 – 1994 | Recommended Vaccines

Diphtheria*
Tetanus*
Pertussis*
Measles**
Mumps**
Rubella**
Polio (OPV)
Hib

1994 – 1995 | Recommended Vaccines

Diphtheria*
Tetanus*
Pertussis*
Measles**
Mumps**
Rubella**
Polio (OPV)
Hib
Hepatitis B
* Given in combination as DTP
** Given in combination as MMR

Annual updates to the immunization schedule — 1995 to 2010

As more vaccines became available, an annual update to the schedule was important because of changes that providers needed to know, such as detailed information about who should receive each vaccine, age(s) of receipt, number of doses, time between doses, or use of combination vaccines. New vaccines were also added.

Important changes to the schedule between 1995 and 2010 included:

New vaccines: Varicella (chickenpox – 1996), rotavirus (1998-1999; 2006, 2008); hepatitis A (2000); pneumococcal vaccine (2001)
Additional recommendations for existing vaccines: influenza (2002); hepatitis A (2006)
New versions of existing vaccines: acellular pertussis vaccine (DTaP ,1997); intranasal influenza (2004)
Discontinuation of vaccine: Oral polio vaccine (2000)

2000 | Recommended Vaccines

Diphtheria*
Tetanus*
Pertussis*
Measles**
Mumps**
Rubella**
Polio (IPV)
Hib
Hepatitis B
Varicella
Hepatitis A

2005 | Recommended Vaccines

Diphtheria*
Tetanus*
Pertussis*
Measles**
Mumps**
Rubella**
Polio (IPV)
Hib
Hepatitis B
Varicella
Hepatitis A
Pneumococcal
Influenza

2010 | Recommended Vaccines

Diphtheria*
Tetanus*
Pertussis*
Measles**
Mumps**
Rubella**
Polio (IPV)
Hib
Hepatitis B
Varicella
Hepatitis A
Pneumococcal
Influenza
Rotavirus
* Given in combination as DTaP
** Given in combination as MMR

The schedule from 2011 to Present

Annual updates to both the childhood and adult immunization schedules offer guidance to healthcare providers in the form of new recommendations, changes to existing recommendations, or clarifications to assist with interpretation of the schedule in certain circumstances. The schedules are reviewed by committees of experts from the Centers for Disease Control and Prevention, the American Academy of Pediatrics, and the American Academy of Family Physicians.

Important changes to the schedule:

New vaccines: meningococcal serogroup B vaccine (2014); COVID-19 (2021-2022)†
Additional recommendations for existing vaccines: HPV (2011 to routinely vaccinate males), intranasal influenza vaccine (2018 again recommended)
Discontinuation of vaccine: intranasal influenza vaccine (2016)

^†COVID-19 vaccines were recommended during the pandemic for increasingly younger age groups starting in late 2020. They were recommended for 5- to 11-year-olds in 2021, but they were not recommended for those younger than 5 years of age until 2022. COVID-19 vaccine was not added to the immunization schedule until 2023.

2020 | Recommended Vaccines

Combination vaccines

In the early 1950s, four vaccines were available: diphtheria, tetanus, pertussis and smallpox. Because three of these vaccines were combined into a single shot (DTP), children received five shots by the time they were 2 years old and not more than one shot at a single visit.

By the mid-1980s, seven vaccines were available: diphtheria, tetanus, pertussis, measles, mumps, rubella and polio. Because six of these vaccines were combined into two shots (DTP and MMR), and one, the polio vaccine, was given by mouth, children received five shots by the time they were 2 years old and not more than one shot at a single visit.

Since the mid-1980s, many vaccines have been added to the schedule. The result is that the vaccine schedule has become more complicated than it once was, and children are receiving far more shots than before (see Vaccine Safety for answers to the questions: “Are vaccines safe?”; “Do vaccines weaken the immune system?” and more). Now, children could receive as many as 27 shots by 2 years of age and up to six shots in a single visit. However, in the same way that the DTaP and MMR vaccines were combined, new combinations are being made to reduce the number of shots. Used in different age groups of children, the following combinations of vaccines are now available:

Diphtheria, tetanus and acellular pertussis
Diphtheria, tetanus, acellular pertussis, and inactivated polio
Diphtheria, tetanus, acellular pertussis, inactivated polio and hepatitis B
Diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b
Diphtheria, tetanus, acellular pertussis, inactivated polio, Haemophilus influenzae type b, and hepatitis B
Measles, mumps and rubella
Measles, mumps, rubella, and varicella
Hepatitis A and hepatitis B (only for those 18 years of age and older)

Vaccines for Adolescents: A new generation of vaccines

Adolescents, like adults, were recommended to get tetanus boosters every 10 years; most requiring their first booster dose around age 11. Other than this, however, most adolescents did not require additional vaccines unless they missed one in childhood. By 2005, vaccines specifically recommended for adolescents were only recommended for sub-groups based on where they lived or medical conditions that they had. However, a new group of vaccines became available in the latter part of the decade.

New vaccines: Tdap, 2005, meningococcal conjugate (2005), HPV (2006 females, 2009 males), meningococcal serogroup B vaccine (2014); dengue (2021); COVID-19 (2020-2021)^†
Additional recommendations for existing vaccines: HPV (2011 to routinely vaccinate males), intranasal influenza vaccine (2018 again recommended)
New versions of existing vaccines: HPV (protecting against 9 types, 2015)
Discontinuation of vaccine: intranasal influenza vaccine (2016)

^†COVID-19 vaccines were recommended during the pandemic for increasingly younger age groups starting in late 2020. They were recommended for those 16 years and older in late 2020, but they were not recommended for 12- to 15-year-olds until 2021. COVID-19 vaccine was not added to the immunization schedule until 2023.

2000

Recommended Vaccines
Td

Catch-up
MMR
Hepatitis B
Varicella

Sub-groups
Hepatitis A

2005

Recommended Vaccines
Tdap

Catch-up
MMR
Hepatitis B
Varicella

Sub-groups
Hepatitis A
Pneumococcus
Influenza

2010

Recommended Vaccines
Tdap
HPV
Meningococcal conjugate (serogroups A,C,W,Y)
Influenza

Catch-up
MMR
Hepatitis B
Varicella
Polio

Sub-groups
Hepatitis A
Pneumococcus

2020

Recommended Vaccines
Tdap
HPV
Meningococcal conjugate (serogroups A,C,W,Y)
Influenza
Meningococcal serogroup B

Catch-up
MMR
Hepatitis B
Varicella
Polio

Sub-groups
Hepatitis A
Pneumococcus

Vaccines for adults — increasing opportunities for health

Historically, vaccines were deemed to be “only for children.” However, vaccines for adults are becoming increasingly common and necessary. Most adults think only of the tetanus booster recommended every 10 years and even then, many adults only get the vaccine if they injure themselves. In 2005, the Tdap vaccine was licensed as an improved version of the typical tetanus booster, Td. The newer version also contains a component to protect against pertussis (whooping cough). All adults, especially those who are going to be around young infants, should get the Tdap vaccine. Adults often unwittingly pass pertussis to young infants for whom the disease can be fatal. In 2012, the CDC recommended that pregnant women get a dose of Tdap during each pregnancy between 27 and 36 weeks gestation. In 2019, the CDC recommended that Tdap or Td vaccine could be used for booster dosing every 10 years.

Influenza vaccines, available since the 1940s, are now recommended for most adults. Vaccines like MMR and chickenpox are recommended for adults who have not had the diseases, and vaccines including hepatitis A, pneumococcus, and meningococcus are recommended for sub-groups of the adult population. The HPV vaccine became available in 2006. In 2018, the license was expanded to include people up to 45 years of age. In 2022, recommendations for expanded use of hepatitis B vaccine included all adults through 59 years of age who had not previously been vaccinated.

The first shingles vaccine, Zostavax, was licensed in 2006; a second shingles vaccine, Shingrix, licensed in 2017, produces a more robust immune response than Zostavax did. Two doses of this vaccine, separated by two to six months, are recommended for people 50 years and older. In 2019, Zostavax was no longer available.

In late 2020, the first COVID-19 vaccines were approved for use in response to the COVID-19 pandemic. Most adults were recommended to get this vaccine, but limited supplies required adults to be assigned to eligibility groups in order to protect those most at risk first. COVID-19 vaccine was not added to the immunization schedule until 2023.

In 2023, the first vaccines against respiratory syncytial virus (RSV) became available for adults 60 years of age and older.

Unlike childhood vaccines, which are often required for entrance to schools, adult vaccines are typically not mandated. However, people with certain occupations may be required to get vaccinated as a condition of employment. Most often, this occurs in the military and in healthcare-related occupations, but other industries may also require employment-based vaccinations. Limited requirements and a lack of preventive healthcare by most adults have led to low levels of vaccine use by adults.

Research Finds Vaccines Are Not Behind the Rise in Autism. So What Is?

There is no one factor that causes autism — or explains its growing prevalence. Researchers are seeking explanations for the surge. Here are some possibilities.

When President-elect Donald J. Trump mused in a recent television interview about whether vaccines cause autism — a theory that has been discredited by dozens of scientific studies — autism researchers across the country collectively sighed in frustration.

But during the interview, on NBC’s “Meet The Press,” Mr. Trump made one passing comment with which they could agree: “I mean, something is going on,” he said, referring to skyrocketing rates of autism. “I think somebody has to find out.”

What is going on? Autism diagnoses are undeniably on the rise in the United States — about 1 in 36 children have one, according to data the Centers for Disease Control and Prevention collected from 11 states, compared with 1 in 150 children in 2000 — and researchers have not yet arrived at a clear explanation. They attribute most of the surge to increased awareness of the disorder and changes in how it is classified by medical professionals. But scientists say there are other factors, genetic and environmental, that could be playing a role too.

Autism spectrum disorder, as it is officially called, is inherently wide-ranging, marked by a blend of social and communication issues, repetitive behaviors and thinking patterns that vary in severity. A mildly autistic child could simply struggle with social cues, while a child with a severe case could be nonverbal. There is no blood test or brain scan to determine who has autism, just a clinician’s observations.

Because there is no singular cause of autism, scientists say there is therefore no singular driver behind the rise in cases.

But at the heart of the question is an important distinction: Are more people exhibiting the traits of autism, or are more people with such traits now being identified? It seems to be both, but researchers really aren’t sure of the math.

Here is what they know.

An Elusive Cause

More than 100 genes have been associated with autism, but the disorder appears to result from a complex combination of genetic susceptibilities and environmental triggers.

The C.D.C. has a large-scale study on the risk factors that can contribute to autism, and researchers have examined dozens of potential triggers, including pollution, exposure to toxic chemicals and viral infections during pregnancy.

Some research suggests that babies born to older parents — particularly an older father — may be at increased risk of autism. Other studies hint that premature birth or low birth weight could be associated with autism, which is often linked to high oxidative stress.

The idea that such factors could also be involved in the overall rise in autism is convincing to Juergen Hahn, a professor at Rensselaer Polytechnic Institute who studies the computational systems biology of autism, given that both the number of children surviving premature birth and the average age of new parents are rising.

But testing a hypothetical driver of autism would mean controlling for the endless list of other influences on early development and following the child well into adulthood, when some people now receive their diagnosis.

“These are very complicated studies to conduct, especially if you want statistical certainty, and there are no easy answers,” Dr. Hahn said. “Sometimes we just have to say we don’t know. And that always gives people room for speculation.”

The misinformed theory that vaccines are behind the disorder is one such case of speculation. It gained traction when a British researcher named Andrew Wakefield published a study of 12 children in the late 1990s, purporting to reveal a link between the measles, mumps and rubella vaccine and autism.

Many larger studies have since discredited the hypothesis, including one that enrolled the entire Danish child population. Regardless of the types of vaccines, the ingredients or the timing of the schedule, researchers have not been able to establish a link. Dr. Wakefield’s article was retracted, and he lost his medical license, but the seeds had been planted in social discourse.

Diagnostic Changes

One component in the boom of autism cases is far more certain: the broadening parameters of the spectrum.

Autism first appeared in the Diagnostic and Statistical Manual of Mental Disorders in 1980, in the guide’s third edition, but its definition changed in 1987, when it came to include children whose symptoms appeared at older ages — after 30 months. The new edition also expanded the criteria for a diagnosis of autism, to 16 from six, and said children needed to exhibit only half of the 16 criteria listed, rather than all six of the previous criteria.

A fourth edition of the D.S.M., published in 1997, included Asperger syndrome, a social disorder that can be marked by a preoccupation with a single interest, on the autism spectrum. That was a significant shift, since it meant that all people — including those with average or even above average intellectual abilities — could receive the diagnosis.

The fifth edition, released in 2013, allowed clinicians to give a combined diagnosis of autism spectrum disorder and attention deficit hyperactivity disorder. It also folded autism, Asperger syndrome and a condition called PDD-NOS — short for pervasive developmental disorder-not otherwise specified — under a single umbrella.

“What we call autism has itself changed to become a broader category,” said Simon Baron-Cohen, the director of the Autism Research Center at the University of Cambridge. And, he said, with “the growth in private clinicians offering diagnosis — it has become an industry.”

Increased Awareness

As those clinical processes were evolving, so was the social infrastructure. Until the 1980s, many people with autism were institutionalized, so parents were far less familiar with the hallmark traits of the disorder and typically did not recognize them or seek a diagnosis when they occurred in their own child.

Then, in 1991, children with an autism diagnosis began to qualify for special services in schools, which gave parents an incentive to seek out and accept diagnoses. Around 2007, the American Academy of Pediatrics recommended that all children be screened for autism at 18 and 24 months, which experts believe led to a major uptick in detection.

Several changes in population-level trends add further evidence that awareness and inclusion could be behind the surge. Historically, boys have been diagnosed with autism at far higher rates than girls, who are thought to “mask” their autism symptoms because of social norms. But in an era of greater acceptance for neurodiversity, the gender gap is narrowing.

Hispanic, Black and Asian children showed major increases in autism diagnoses compared with white children between 2011 and 2022, which could reflect improved access to diagnostic services. And — perhaps most indicative — relative increases in autism diagnosis rates in the last decade were greatest not among children, but among adults ages 26 to 34, many of whom were seeking their own diagnosis for the first time.

Researchers also point to the influence of social media as “one of the biggest unrecognized factors driving the explosion of autism diagnoses,” Dr. Baron-Cohen said. Platforms like Reddit, he said, became a space “where people who might wonder if they or their child were autistic could communicate with each other and feel a new sense of belonging and identity,” he said.

Still, for Catherine Lord, a psychologist at the University of California, Los Angeles, who has developed diagnostic tools and longitudinal studies for autism, the math just isn’t working.

“Some of it is clearly from greater awareness and broader inclusion,” she said. But even if those are the biggest factors driving the surge, and even if biological and environmental factors are contributing as well, she said, “it seems a little far-fetched to think that all of these add up to the increase.”

She is confident, though, from copious data in both the United States and abroad, that heightened autism prevalence does not correspond to childhood immunizations.

“Whatever it is,” she added, “it’s not vaccines.”

Conclusion

I am sorry, I don’t see that they have down a double blind study on vaccines and their affect on autism. The research has just not conclusively disproved it. There is also the problem that chemicals in our diet have caused the increase of autism. This argument might hold water if the numbers of autism were limited to just the US. There is no secret that countless food additives that are commonly added to our foods are now banned in Europe and Asia. The only commonality between the US and Asia and Europe are that the number of childhood vaccines have increased.

According to current research, the reported prevalence of autism spectrum disorder (ASD) has significantly increased globally, with studies showing a rise in diagnosed cases over time; this is largely attributed to factors like improved awareness, changes in diagnostic criteria, and better case identification practices, rather than a true biological increase in autism itself.

Key points about the apparent increase in autism:

Improved awareness:Greater public understanding of autism leads to more individuals being evaluated and diagnosed.
Diagnostic criteria changes:Modifications to the DSM (Diagnostic and Statistical Manual of Mental Disorders) can influence diagnosis rates.
Global trend:Studies across different regions show a consistent increase in reported autism prevalence.

New study shows increase in global prevalence of autismApr 29, 2022 — New study shows increase in global prevalence of autism | Autism Speaks. New study shows increase in global prevalence…

Food Additives Banned in Europe May Be Making Americans Sick

The food we regularly buy in grocery stores in the U.S. may not be as safe as once thought. Although most people believe the food in stores is harmless, a professor from England’s University of Sussex is raising concerns about what Americans eat. Various chemicals and substances that are popular ingredients in U.S. foods are actually banned throughout Europe. Continue reading to find out what some experts are saying about the dangers lurking in the U.S. food supply.

Several U.S. Food Additives Are Prohibited in Europe

Bread is a staple food in American and European diets. However, there is a major difference in the bread Europeans consume compared to the bread Americans eat. European bread lacks a specific ingredient: Potassium bromate. Food makers in the United States regularly use this chemical compound to strengthen dough. In fact, this additive is present in more than 100 products. But, Europe, China, and India have banned Potassium bromate due to concerns that it may be a carcinogen.

Professor Erik Millstone, an expert on food additives at England’s University of Sussex, told CBS News that potassium bromate may be toxic to human consumers and could even cause tumors.

Potassium bromate is not the only culprit. Other potentially harmful substances outlawed in Europe but found in the U.S. include:

Titanium dioxide (also known as E171)
Brominated vegetable oil (BVO) (E443)
Potassium bromate (E924)
Azodicarbonamide (E927a)
Propylparaben (E217)

Why Hasn’t The FDA Banned These Ingredients?

Most Americans are likely unaware they are being exposed to substances in their food that Europe considers dangerous. Professor Millstone believes European regulators are more cautious about food safety than their U.S. counterparts.

The FDA stated all food additives require pre-market evaluation before they are added to foods. These regulations require evidence that each substance is safe at its intended level. Also, the agency added that scientists review new information to reassess the safety of each substance.

However, this hasn’t stopped some Americans from relocating to other parts of the world where food regulations are stricter.

Vaccines equal money

Nobody is talking about how much money there is in Vaccinations. So I have included a posting on how much money is made by big pharma.

Do pharmaceutical companies make big profits from vaccines?

Vaccines are created and tested by pharmaceutical companies, for-profit organizations that are designed to make money. Yet, the truth is that childhood vaccines are among the least profitable products for big pharma. These companies make the lion’s share of their profits by selling drugs that treat diseases and health conditions.

For example, sales of the Sovaldi drug for Hepatitis C — just one treatment by one pharmaceutical company for one disease sold almost entirely in the United States — exceeded more than $10 billion in one year. Annual sales for a drug like Viagra pull in close to $2 billion annually. The total pharmaceutical revenue in the US is a staggering $482 billion per year.

In comparison, the total revenue possible per year if all childhood vaccines were given to every child born in the US from their birth until 18 years of age would be only $8 billion – equal to only 1.7% of pharma sales. So, even vaccinating every child with every vaccine to prevent multiple illnesses across the country would bring in less revenue than one single drug is capable of bringing in to treat a single infection in some people.

Regardless of how profitable a product is, however, the most critical focus to guide patients on the use of a product should be on its clinical risks and benefits, including whether vaccines are continually tested, safe, and provide protection against diseases, which they do. (See more on vaccine safety here.)

Another point of comparison: Alternative Medicine

Another illuminating example is the alternative medicine market, which includes homeopathic remedies (e.g., Arnica, elderberry syrup, and Zicam) and various supplements, powders, and teas.

This is a huge $34 billion industry in the US, with only one-third of the treatments tested, yet isn’t as readily labeled as a money-maker.

In short, if pharmaceutical companies merely wanted to increase their profit margins, they would make more money by focusing such efforts on developing and selling drugs, or even selling alternative medicine.

Do doctors profit from vaccines?

Another concern that some have is whether doctors push vaccines on patients because they get paid extra by insurance companies to promote them.

In the United States, research shows that pediatricians make little or no money when giving vaccines. In fact, some doctors make less money when providing vaccines because the administrative costs (nursing time, billing time, cost of supplies, etc.) exceed the reimbursement they receive from insurers and health plans.

Some insurance companies do provide a “quality of care” bonus to doctors if they meet an array of health-promoting measures such as regular well child checks, appropriate asthma management, and up to date immunizations. This incentive isn’t big enough to make doctors change their clinical recommendations, but rather designed to prevent low vaccination rates caused by other factors such as forgetting to check a child’s immunization record. The insurance companies make this decision based on the cost-benefit analysis: Patients who are vaccinated and have regular checkups are less likely to need expensive, disease-related care in the future. Without understanding all of the details and nuances of the bonus, it can sound like doctors are secretly profiting, but the truth is that most doctors’ salaries are not impacted much at all by vaccines.

Dr. Ryan Hassan, a local pediatrician, and volunteer for Boost Oregon, says, “I became a pediatrician because I want to keep kids healthy. If my primary goal were instead to make money, I would have chosen a different, more lucrative specialty.”

Dr. Joel Amundson, member of Boost’s Medical Advisory Board, adds, “I am passionate about evidence-based medical care for children. I am an advocate for parents to understand the medical choices that they have for their children and feel empowered to make choices they feel great about.”

Doctors go through years of training and are experts in their field(s). They make recommendations based on experience, scientific research, and the benefits of vaccines.

So obviously Big Pharma has a vested interest in protecting their cash cow. So what does this mean? How can they protect their drugs, well one way is to fund the clinical studies. Clinical studies are increasingly being funded by pharmaceutical companies (e32– e35). Professional medical bodies construct evidence-based guidelines on the basis of published trial results, so their recommendations may be flawed.

Big Pharma Is Hijacking the Information Doctors Need Most

Back in 1982, when I first began my career as a family practitioner in a small town of Boston, I was confident that the care I’d provide would be as effective as the care patients receive anywhere in the world. At the time, the death rate for Americans was lower than that of comparable countries, resulting in 128,000 fewer deaths annually. Although healthcare was expensive—costing 2.3% more of our GDP than the average of 11 other wealthy countries—the rapid growth of HMOs and managed care plans promised to make our healthcare even more effective and efficient.

Over the ensuing four decades, however, the opposite has occurred. The same age-adjusted mortality rate has improved so much more in comparable countries that, by 2017, an excess 478,000 Americans were dying each year. This translates into an extra 1,300 deaths daily, equivalent to three jumbo jets crashing every day. The everyday poor health of Americans and the inability of our healthcare system to mitigate preventable deaths amounts to a crisis that dwarfs even the COVID-19 pandemic. And our excess spending has risen to 6.8 percent of GDP, or $1.5 trillion per year.

This raises a key question: Why have so many smart, well-trained doctors stood by as American healthcare descended into a state of profound dysfunction?

The answer lies in the gradual, nearly invisible commercial takeover of the medical “knowledge” that doctors are trained to trust.

This transition started in the 1970s, when the acceptance rate of grant applications for funding from the National Institutes of Health shrank—from roughly half of medical research applications to one-third. Then, in 1981, President Ronald Reagan slashed government support of university-based medical research, further pushing academic researchers into the waiting arms of industry, especially pharmaceutical companies. Following the 1980 passage of the University and Small Business Patent Procedures Act, nonprofit institutions and their researchers were allowed to benefit financially from the discoveries made while conducting federally funded research.

Former president of Harvard University Derek Bok expressed concern about the growth of commercial activities within academia: “Making money in the world of commerce often comes with a Faustian bargain in which universities have to compromise their basic values—and thereby risk their very souls…”

The biggest shift was, however, still to come.

Over the past few decades, the drug companies have taken over most of our clinical research. In 1991, academic medical centers (AMCs)—hospitals that train doctors and conduct medical research—received 80 percent of the money that industry was spending to fund clinical trials. The drug companies relied on academic researchers for their expertise in designing studies, enrolling patients, and analyzing the data. This arrangement allowed academics to receive the funding they needed while still preserving much of their independence. But by 2004, the percentage of commercially funded clinical trials conducted by AMCs had fallen from 80 to just 26 percent.

A look at the research contracts between corporations (mostly Big Pharma companies) and academic medical centers shows that 80% allowed the commercial funder to own, and thus control, the data from jointly conducted research. Furthermore, fully half of the research contracts between drug companies and academic institutions—the partnerships with the highest likelihood of upholding rigorous research standards—allowed industry insiders to ghostwrite clinical trial reports for publication in scientific journals, relegating the named authors to the position of “suggesting” revisions.

Nonetheless thorough peer review ensures that these reports are accurate, right? Wrong. Unbeknownst to almost all doctors, peer reviewers are not granted access to the underlying data that serves as the basis for the reported findings. The drug companies own that data and keep it confidential as “corporate property.” Reviewers must rely on brief data summaries included in the submitted manuscripts. Peer reviewers at even the most prestigious medical journals cannot possibly attest to the accuracy and completeness of the articles they review.

This sham was exposed in 2005 when the editors of an article published in the New England Journal of Medicine admitted they had not seen relevant data from a clinical trial involving Merck’s arthritis drug Vioxx. Five years earlier, the article had extolled the drug’s safety even though neither the editors nor the peer reviewers had been granted access to underlying data, which showed three heart attacks that had occurred in patients treated with Vioxx were not reported. Had this data had been properly disclosed and analyzed when the manuscript was first submitted, the article would have shown that Vioxx significantly increased the risk of heart attack five-fold when compared to over-the-counter naproxen (Aleve). And many of the estimated 30,000 Americans who died as a result of taking Vioxx after the incomplete article was published would not have been exposed to the drug.

To this day, Big Pharma companies remain unwilling to disclose their underlying clinical trial data. The most recent example involved Pfizer’s COVID-19 vaccine. In September 2021, one month after the vaccine had been granted full approval by the U.S. Food and Drug Administration (FDA), a group of medical researchers and scientists sued the agency for the release of 451,000 pages of scientific documents it had evaluated prior to granting the vaccine full approval. Even though the agency required only 108 days to sufficiently evaluate these documents before granting the vaccine formal approval, the FDA (with Pfizer wanting to join the lawsuit), argued that the fastest they could release the data was five hundred pages per month, meaning that it would take seventy-five years before the documents were released in full. On January 6, 2022, U.S. District Judge Mark Pittman ruled that the FDA must release 55,000 (not 500) pages of the documents each month until complete.

I want to be clear that I’m a strong advocate of getting vaccinated and boosted (especially for people age 65 and older), the CDC’s analysis of real-world data shows that last December unvaccinated adults had 41 times the risk of dying of COVID-19 compared to fully vaccinated and boosted adults. But I believe just as strongly that doctors and the public must have access to the underlying clinical trial data that the FDA approval is based upon now—not in seventy-five years.

The lack of transparency of clinical trial data in peer review is similar around the world. But the effect is far greater in the U.S. because of our unique pharmaceutical policy. We have no formal assessment that compares the medical benefit and economic value of new drugs to older therapies, so health-care professionals do not have access to this critically important information.

Federally funded clinical practice guidelines are not allowed to include the relative cost of therapies in their recommendations, which means there is no consideration given to the chance that a drug may unnecessarily bankrupt patients or inflate the cost of health insurance. Further, the price of brand-name drugs is unregulated in this country, which is why they cost 3.5 times more in the U.S. than in other OECD countries. And unregulated prices increase the reward-to-risk ratio for overly aggressive marketing practices in the U.S.

The industry’s control over what doctors believe about optimal therapeutics explains why new, expensive drugs are used more liberally in the U.S. than other countries. Without access to the actual clinical trial data, medical journals are publishing unvetted articles that doctors then rely on to treat their patients. Although prescription drugs “only” account for 17% of U.S. health-care expenditures, this has become a “tail wags dog” situation: The drug companies control the “knowledge” that informs doctors’ clinical decisions. This leads to soaring pharmaceutical profits and crippling healthcare costs, while doctors have no way of knowing which therapies are more effective—or more efficient. Americans deserve better.

Hopefully I have given you enough information so that you can make up your own mind on the matter. Remember a double blind study is the gold standard. How many of these research studies have been carried out with these stringent criteria. I am sure that they are few and far between.

RFK, Jr. Is Wrong about Cause of Rising Autism Rates, Scientists Say

(Update 4/17/2025 2:49 PM)

Robert F. Kennedy, Jr., head of the Department of Health and Human Services, struck an alarmist tone about new findings that one in 31 eight-year-olds in the U.S. have an autism diagnosis at a press conference today.

Kennedy called autism a “tragedy” that “destroys families.” And his statements also included assertations that autism experts say are out of date, such as the idea that autistic kids “regress” around their second birthday. In fact, while autism is often diagnosed at this age, researchers have found brain differences as early as six months of age among kids who were later diagnosed as autistic. Some studies have also found subtle differences in motor behavior and social behavior, such as looking less at people than typically developing kids do, in babies who were later diagnosed as autistic.

But Kennedy’s greatest breach with the scientific consensus was likely his insistence that autism is an “epidemic” that must be caused by an environmental exposure that has been introduced within the past several decades. In fact, researchers say, autism is between 60 and 90 percent heritable. And in up to 40 percent of cases, doctors can find a specific set of genetic mutations to explain the condition. While there are environmental risk factors for autism, such as air pollution, rising rates are mostly attributable to broadened diagnostic categories and more comprehensive screening.

“The problem from a science communication standpoint is that the causes are complex,” says Annette Estes, director of the University of Washington Autism Center. “It’s not like Down syndrome, where we can say, ‘There is one genetic change that leads to this syndrome, and everybody with this syndrome has these characteristics.’ Even though the amount we’ve learned is unbelievable, it’s also not a simple story.”

The new finding that one in 31 kids born in 2014 are autistic comes from a newly released report from the Autism and Developmental Disabilities Monitoring Network (ADDM), which started tracking data in 2000. That year one in 150 eight-year-olds were diagnosed as autistic, and the number has been steadily rising since. Kennedy also cited numbers from the 1970s and 1980s that showed rates of autism that represented around one to three in 10,000 people.

This period saw a number of changes in how autism was diagnosed, however. The Diagnostic and Statistical Manual of Mental Disorders (DSM), which has lays out criteria for psychiatric diagnoses in the U.S., called autism “schizophrenic reaction, childhood type” in its first edition and subsequently referred to it as “schizophrenia, childhood type” until 1980, when the diagnosis changed to “infantile autism.” The criteria then focused on external symptoms such as delays in language development, resistance to change and attachments to objects. In 1987 the criteria widened and encompassed three categories related to social interaction, communication and restrictions in activities. In 1994 the diagnosis of Asperger’s disorder appeared, only to be subsumed into a broadened “autism spectrum disorder” in the DSM’s fifth edition (DSM-5) in 2013. That year was also the first in which autism and attention deficit hyperactivity disorder could be diagnosed in the same child at the same time, Estes says. Prior to that time, an ADHD diagnosis would preclude a child from getting an autism diagnosis, even though researchers currently estimate that half or more of autistic people also have ADHD.

Kennedy downplayed diagnostic shift as a minor explanation for the increase in autism cases, but researchers have found that changes in diagnosis probably explain a majority of the increase. A 2015 study on children diagnosed as autistic in Denmark, for example, found that 60 percent of the rise of autism among children born between 1980 and 1991 was caused by changes in diagnostic criteria and reporting practices. Another 2015 study examined students in U.S. special education programs between 2000 and 2010. The number of autistic children who enrolled in special education tripled from 93,624 to 419,647. In the same time frame, however, the number of children labeled as having an “intellectual disability” declined from 637,270 to 457,478. The shift of children from one diagnostic category to another explained two thirds of the increase in autism in this population, researchers say.

Another piece of evidence for changes in diagnosis explaining a large difference in the prevalence of autism is that autism rates vary widely from state to state in the U.S. The state with the highest prevalence of autism is California, with a rate of 53.1 per 1,000 eight-year-olds, while the one with the lowest prevalence is Texas, with a rate of 9.7 per 1,000 eight-year-olds. That’s a huge difference. But according to the CDC’s own report, it’s likely linked to California’s intense push for early screening and assessment.

“Because of all the hard work that everyone has done to come up with good approaches for supporting and teaching autistic kids, there are benefits of getting an autism diagnosis,” Estes says. “So people seek it out. And that, coupled with less stigma around autism, means more people want to understand their kids in this way.”

Some portion of the rise in autism rates may be unrelated to better diagnosis. The likelihood of having an autistic child increases for older parents, and there is a societal trend toward delaying childbirth across developed countries. Children who are born prematurely are also at a heightened risk of autism, and improved neonatal care means many more of these children are surviving to childhood and beyond.

There are also known environmental risk factors for autism. Among pregnant people, for example, infections that are accompanied by fever in the second trimester raise the risk of autism for their eventual baby. So does exposure to fine particulate matter pollution in the third trimester of development and the first year of life, according to a 2019 study. Laura McGuinn, an epidemiologist at the University of Chicago, who led a study that made the latter finding, says that particulate matter is inflammatory, and work is ongoing to understand how it might trigger the maternal immune system and potentially affect brain development.

As Secretary of Health and Human Services, Kennedy promised “some” of the answers to the causes of autism by September. But his “start from scratch” approach largely ignores research that has already been done. For example, Kennedy told reporters the initiative would look at ultrasounds during pregnancy as a possible risk factor. But a comprehensive multisite study of more than 1,500 pregnancies that found no link between autism and ultrasound use was published as recently as 2023. And scientists definitively ruled out the measles, mumps and rubella (MMR) vaccine as a cause of autism a decade ago (and again in 2019). In addition, the primary study that had suggested a link between the MMR vaccine and autism was found to have falsified data. Despite this, federal officials said in March that the Centers for Disease Control and Prevention will conduct a study to investigate a link between vaccines and autism. The study will be led by a vaccine skeptic who was previously disciplined for practicing medicine without a license.

Work on untangling the complex environmental risk factors was ongoing prior to Kennedy’s tenure, including at federal agencies such as the National Institute of Environmental Health Sciences, which is developing a Web-based tool to help scientists make sense of the existing data on environmental studies and autism.

“As scientists, I wish there was a way we could talk about this and really explain how amazing it is, how much taxpayer money has gone to creating this understanding of this complex developmental disorder and how to help kids and parents,” Estes says. “This idea that there needs to be one single cause, and it needs to be really scary—it’s just really taking us backward.”

Resources

nytimes.com, “Research Finds Vaccines Are Not Behind the Rise in Autism. So What Is?” By Emily Baumgaertner; chop.edu, “Vaccine History: Developments by Year.”; thelakelawfirm.com, “Food Additives Banned in Europe May Be Making Americans Sick.”; boostoregon.org, “Vaccine Myth: Vaccines are Just Money-Makers for Big Pharma & Doctors.”; time.com, “Big Pharma Is Hijacking the Information Doctors Need Most.” By John Abramson; Scientificamerican.com, “RFK, Jr. Is Wrong about Cause of Rising Autism Rates, Scientists Say.” By Stephanie Pappas;

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