The Discovery of Rotavirus: Every Solution Needs a Problem
Most physicians are wrong in their understanding of most diseases, most of the time.
– Alan Cantwell, M.D.
The story of the discovery of rotavirus and the invention of the rotavirus vaccine is the quintessential example of everything that’s wrong with the vaccine industry.
Rotavirus, named after the Latin word for wheel (rota), is said to be the most common cause of diarrhoeal disease among infants and young children. The virus is allegedly transmitted by the fecal-oral route, damaging cells that line the small intestine, causing gastroenteritis.
While diarrheal infections have plagued humans since antiquity, the official history of rotavirus begins in 1943, when Jacob Light and Horace Hodes claimed they found an agent believed to be the cause of the diarrhea epidemic afflicting newborns in the Baltimore–Washington D.C., area at that time.
Light and Hodes gave the stool of affected babies nasally to calves via a filtration method, then waited to see if the disease would replicate itself in the calves.
After performing this test, they acknowledged that “[t]he calf[,] like the human infant[,] is naturally prone to diarrheal episodes from a variety of causes[,] and the mere appearance of diarrhea following the injection of a calf would not necessarily signify that successful passage had been carried out.” Nonetheless, they cautiously claimed that, “though it is not conclusive,” the evidence suggests “the agent may be the cause” of the diarrhoeal epidemic in the newborns.
Nowhere in their analysis, though, did Light and Hodes mention the grinding poverty, poor sanitation, and overcrowded housing conditions that were signature features of big-city life, including in the Baltimore–Washington D.C., area, during and after World War II.
In 1973 at the Royal Children’s Hospital (RCH) in Melbourne, Australia’s Ruth Bishop and her team of researchers would advance the hypothesis of a sole causal agent for gastrointestinal disorders. Utilizing electronmicroscopy they observed novel wheel-shaped virus fragments in feces of children with severe diarrhea.
Three decades later, in 2009, Bishop wrote an article titled “Discovery of rotavirus: Implications for child health, “in which she observed, “In the early 1900s, 100–200 of every 1,000 babies born in Victoria died before their first year of life.” She attributed the cause of this mortality to diarrhoeal disease, which she called “summer diarrhea,” since it mainly occurred during Australia’s hottest months.
In the same 2009 article, Bishop noted that by 1940 death rates from gastroenteritis in young children in Victoria had plummeted to 1.64/1,000 live births. She cited multiple factors for the drop in death rates, such as “increased hygiene in the home, availability of refrigeration and home ice-boxes, proper sewage disposal, changes in hospital attitudes to admission and advances in treatment.” [Emphasis added.]
Notably, this significant and welcome decrease in child mortality came well before the “discovery” of the rotavirus itself, not to mention decades before the creation of the rotavirus vaccine. Such historical data suggests that the diarrhoeal condition might have causes other than an alleged pathogen and could be resolved through improved living standards, nutrition, and sanitation.
Yet something seemed to prevent Dr. Bishop from exploring the association of the disease with basic living standards—despite it being her own observation.
One possible explanation for why Dr. Bishop ignored her own conclusion is found in the forward to her article, where she disclosed that she “received funding from GSK and Merck for travel to Conferences to present reviews of rotavirus vaccine research, and for financial support of laboratory research on epidemiology of rotavirus serotypes in Australia; and [that she] has been an employee of the Murdoch Children’s Research Institute which is developing a novel rotavirus vaccine.” [Emphasis added.]
Murdoch Children’s Research Institute is a long-time recipient of multiple grants, including an appreciable amount of money from the Bill & Melinda Gates Foundation, which benefits handsomely from the vaccine industry.
Close inspection exposes a cozy, ongoing relationship between the two organizations, with a steady stream of financial contributions flowing from the Foundation to the Institute.
A partial list of grants reveals quite the bonanza of funding:
- a 2012 grant of $3,902,497 for RV3 Rotavirus Vaccine: a human neonatal rotavirus vaccine for the global community;
- a 2014 grant for $6,789,668 for RV3 expanded trial implementation;
- a 2014 grant of $7,992,593 for Immunogenicity and NP carriage study on alternative PCV schedules;
- a 2015 grant of $265,696 for Identification of Novel Correlates of Protection Induced by Rotavirus Vaccine;
- a 2020 grant of $13,425,562 for BRACE BCG Trial for COVID-19;
- a 2020 grant of $2,188,563 for Follow-up of Vietnam Alternate Dosing Schedules;
- a 2021 grant of $1,252,388 for Evaluation of PNEUMOSIL in different dosing schedules;
- of $1,387,959 for TCV cost effectiveness analysis in Indonesia;
- a 2023 grant of $2,099,655 given to the Ruth Bishop Fellowship.
Ruth Bishop’s 1973 discovery of “summer diarrhea” and her subsequent research would ultimately lead to a pharmaceutical gold rush, as virus hunters sought to solve the riddle of the wheel-shaped infectious agent.
In 1988 CDC researchers would publish an article in the Journal of Infectious Diseases in which they concluded that chronic diarrhea in infants, and mortality associated with those conditions, were caused by rotavirus. One of the co-authors, Dr. Roger Glass, would later pen an article touting the Indo-US Vaccine Action Program, highlighting the contributions of the Gates Foundation in the rotavirus vaccine project.
In 1990 a separate report noted, “For most children hospitalized with rotavirus gastroenteritis, no laboratory diagnosis is made and only a small number of deaths from rotavirus infection have been virologically confirmed.” [Emphasis added]
Ignored in the relentless pursuit of a vaccine was the fact that it was already established that deaths and hospitalization caused by infantile diarrhea could be avoided by aggressive oral rehydration. A 1982 controlled study of well-nourished children hospitalized in the United States and Panama found that oral rehydration using a glucose-electrolyte solution was successful in 97 of 98 children who had diarrhea problems.
Additional studies have been produced which illustrate positive outcomes for the simple and underused therapy of oral rehydration and nutritional supplementation to treat acute diarrhea, begging the question, why the rabid pursuit for a vaccine when a cheap and proven solution already exists?
RotaShield: The First Rotavirus Vaccine
As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with the reality, my story was as tame as a holiday postcard.
– John Le Carre, Afterword to The Constant Gardener
In the late 1980s, the leading vaccine candidate for the rotavirus infection was a live simian-human reassortant virus developed in 1974 at the US National Institutes of Health (NIH) by Albert Kapikian and colleagues. The NIH worked in partnership with and subsequently licensed the candidate vaccine to Wyeth-Ayerst Laboratories for large-scale clinical research and development.
Wyeth filed an investigational new drug application in 1987. Early clinical testing of this vaccine, known as RRV-TV (“rhesus rotavirus—tetravalent”), was deemed favorable. As a result, in August 1998 the first rotavirus vaccine, RotaShield, was licensed in the United States.
One month later, the CDC Advisory Committee on Immunization Practices (ACIP) recommended that RotaShield be given to infants at 2 months, 4 months, and 6 months of age.
The vaccine was immediately added to the childhood immunization schedule. In the first nine months of the program, some 600,000 infants were immunized. According to a PubMed article:
During September 1, 1998–July 7, 1999, 15 cases of intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment) among infants who had received RRV-TV were reported to the Vaccine Adverse Event Reporting System (VAERS).
Could these cases of bowel obstruction have been predicted?
Yes, if one accepts the results of a presentation on the rotavirus pre-licensing clinical trials that Dr. Margaret Rennels of the United States Rotavirus Vaccine Efficacy Group gave a year earlier—at a February 1997 ACIP meeting. She was speaking on behalf of Wyeth Laboratories (which was bought by Pfizer in 2009).
In her presentation, Dr. Rennels described a randomized placebo-controlled double-blind study of 1,278 infants aged five weeks to 25 weeks. Each child received three oral doses of either the placebo (a monovalent vaccine) or RotaShield. Infants participating in the study were allowed to receive other routine vaccines during the trials. Safety data was studied for only five days following administration of each rotavirus vaccine dose.
Adverse events noted in this clinical trial included fever, diarrhea, and vomiting. Four trial participants were hospitalized. Dr. Rennels observed “[d]iffering symptoms on individual post-vaccination days between vaccinees and controls” and told ACIP “[i]t could not be determined if this occurred from vaccination or random chance.”
No follow-up studies were performed to answer this question of causation. Instead, Dr. Rennels concluded that “[t]here were no significant safety differences for vaccinated or control children in the incidence of symptoms over the entire surveillance period.”
Yet, during the US Food and Drug Administration’s review process, Dr. Carolyn Hardegree, director of the FDA’s Office of Vaccines Research and Review, raised questions about cases of intussusception—a rare condition in which a portion of the intestine descends—observed in the clinical trials (and explained in the aforementioned PubMed article).
It should be pointed out that the issue of intussusception possibly being connected to the RotaShield vaccine had also been raised at ACIP meetings later in 1997 as well as in 1998, but those concerns had been dismissed.
In a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) in August 1998, Dr. Hardegree asked Dr. Rennels about the five cases of intussusception that had been found among the recipients of the vaccine—compared to zero cases among the placebo groups. (Note: One case would be discovered later among placebo recipients.)
Dr. Rennels responded, “The intussusception was probably due to chance temporal association.”
There were no follow-up questions on intussusception for Dr. Rennels from either Dr. Hardegree or other members of VRBPAC. Nor was there further discussion on these data points during the remainder of the meeting.
Instead, VRBPAC ignored the intussusception findings and voted unanimously to approve RotaShield on August 31, 1998.
In March 1999, it was ACIP’s turn to take up the matter of whether or not to give its blessing to RotaShield. The outcome of the ACIP vote was predictable: The panel officially recommended RotaShield.
On March 19, 1999, the CDC published ACIP’s recommendation in a report headlined “Rotavirus Vaccine for the Prevention of Rotavirus Gastroenteritis Among Children.”
The CDC report noted that the ACIP panel had made the following observations:
- The vaccine has been associated with a statistically significant excess of fever following the first dose compared with placebo;
- Decreased appetite, irritability, and decreased activity also were reported following the first dose of vaccine in some trials;
- A statistically significant excess of fever also was noted after the second dose of RRV-TV;
- In the efficacy study in Finland, vaccinated children had a significantly increased rate of diarrhea after the first dose of vaccine compared with placebo recipients;
- Initial reports noted failure to thrive or growth delay rarely but more frequently among RRV-TV recipients than among placebo recipients in the Finland and U.S. efficacy trials among vaccinated children versus recipients of placebo.
Also, the CDC included the cases of intussusception in its report. Sad to say, when experts blind-reviewed them, most of these cases were found to represent “normal variations” and were deemed “statistically insignificant.” One wonders whether the parents of those infants would have agreed with that dismissive assessment.
In its conclusion, the CDC report recommended routine rotavirus immunization based on “the high morbidity associated with rotavirus gastroenteritis and the favorable cost-effectiveness of immunization.”
The Problems Begin
There have never been any safety studies done for any vaccine in use today that would meet the criteria of scientific proof. All we have are epidemiologic studies, which are indicators but not proof in and of themselves. — Harold Buttram, M.D.
RotaShield was barely out of the gate before reports of problems began surfacing. By May 1999 the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system that monitors the safety of vaccines, catalogued numerous adverse events related to RotaShield, including ten cases of intussusception.
Preliminary data from Minnesota, a state participating in one of the CDC studies, suggested a similar elevated risk for intussusception within the first week after RRV-TV vaccination.
A 2001 retrospective study in The Pediatric Infectious Disease Journal addressed the intussusception problem. The study’s authors noted that during the first year the rhesus rotavirus tetravalent vaccine (RRV-TV) was licensed, VAERS received several reports of intussusception after vaccination. “To evaluate the risk of intussusception,” they wrote, “we conducted a retrospective cohort study in ten managed care organizations.” Their conclusion: “RRV-TV is associated with an increased risk of intussusception.”
As cases of intussusception developed beyond mere “chance temporal association,” the CDC made the decision, in July 1999, to suspend its recommendation of RotaShield. In a follow-up report, the CDC acknowledged a serious problem with this vaccine:
By December 31, 1999, a total of 112 cases of intussusception with illness onset before August 15, 1999, had been reported to VAERS 1 month after the suspension of the rotavirus vaccination program. When the VAERS findings were confirmed by more definitive studies the manufacturer voluntarily recalled the vaccine, and the ACIP recommendations were withdrawn in October 1999.
Given that many significant problems associated with Wyeth’s rotavirus vaccine were known before it began to be associated with intussusception, and given that these issues were discussed in multiple regulatory meetings, it is natural to ask:
How was it that this vaccine sailed through the approval process?
Why were serious warnings of intussusception overlooked and openly dismissed?
The answers to those questions can be found in the vast web of conflicts of interest that constitutes the architecture of the regulatory system and defines the vaccine approval process.
Conflicts of Interest
Medical politics, for example, is a cutthroat power game of the most primitive sort. I much prefer political politics, because there you have the art of the possible, which means you have to compromise. Medical politics is the art of sheer power. — Robert Mendelsohn, M.D.
In August 1999, the US House of Representatives Committee on Government Reform launched an investigation into federal vaccine policy as it pertained to possible conflicts of interest among policymakers. The committee noted that conflicts of interest are widespread. It highlighted RotaShield as a prime example of the incestuous relationships among the regulatory bodies.
The investigation focused on two regulatory agencies: the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), which advises the FDA on the licensing of new vaccines, and the CDC’s Advisory Committee on Immunizations Practices (ACIP), which advises the CDC on guidelines to be issued to doctors and states for appropriate use of vaccines.
The findings of that investigation, published a year later, revealed numerous conflicts of interest among members of both VRBPAC and ACIP and raised significant concerns regarding the approval process of RotaShield and many other childhood vaccines. The report found that “conflict of interest rules employed by the FDA and the CDC have been weak, enforcement has been lax, and committee members with substantial ties to pharmaceutical companies have been given waivers to participate in committee proceedings.”
Specific problems the investigators had with VRBPAC included:
- Many VRBPAC committee members were found to have significant ties to industry, owned stock, or else received funding from pharmaceutical companies.
- VRBPAC members reported concerns regarding RotaShield but still chose to vote for the vaccine.
- For the RotaShield vaccine approval vote, five temporary members were permitted to vote even though VRBPAC’s charter allowed for only four temporary members to vote.
- VRBPAC members who were ineligible to vote due to conflicts were still allowed to participate in discussions.
Conflicts the investigators identified at ACIP included:
- ACIP members did not fully declare their conflicts of interest.
- ACIP members were given a blanket waiver that allowed them to participate in discussions on any topic, even if there was a conflict of interest.
- ACIP members were permitted to vote on vaccine recommendations even when they had financial ties to drug companies that were developing similar or related vaccines.
- ACIP liaison members were not required to disclose their organization’s financial conflicts of interest.
- In the ACIP rotavirus work group, seven out of the ten members had identifiable conflicts of interest with vaccine interest groups and pharmaceutical products. Additionally, those meetings were held in private and no meeting notes were taken. One work group member who had significant conflicts of interest and was ineligible to vote on the use of RotaShield was permitted to work extensively on the recommendations.
The chairman of the House Committee on Government Reform, Dan Burton (R-IN), concluded:
It is clear that the VRBPAC and the ACIP are dominated by individuals with close working relationships with the manufacturers of vaccines. It is also clear that the CDC’s and FDA’s repeated waivers of conflict-of-interest rules have contributed to an environment where ethical considerations and appearances of impropriety are not given the weight that they deserve.
The reform committee’s description of VRBPAC’s and ACIP’s troubling roles in the approval of the rotavirus vaccine was equally severe: It was “a flawed process that led to a poor decision.”
And what defined that flawed process? Among other things:
• Committee members with financial ties to the manufacturer of the vaccine, and producers of competing vaccines, were given waivers to participate in the decision-making process.
• Legitimate concerns about serious side effects and a lack of information were swept aside.
• The CDC’s advisory committee (ACIP) recommended the “RotaShield” for universal use before it was even approved by the FDA.
• The end result was that a product was placed on the market that had to be withdrawn within one year because it was injuring the children it was supposed to protect.
More Vaccines Arrive
Once weapons were manufactured to fight wars. Now wars are manufactured to sell weapons. — Arundhati Roy
With the withdrawal of RotaShield in 1999, attention turned to other rotavirus vaccines already in the pipeline. Within the next decade, two FDA-approved candidates would be approved and recommended for children in the US.
Merck’s entry into the sweepstakes, RotaTeq, received approval in 2006. A genetically engineered vaccine made of live-attenuated human and bovine genetic material from different species of rotavirus strains, RotaTeq is administered orally in three doses at ages 2 months, 4 months, and 6 months.
RotaTeq had the distinction of being one of the most expensive vaccines ever marketed. It was listed at $187.50 wholesale for the three-dose series, meaning doctors could charge more than $300 retail.
The clinical trials that led up to RotaTeq’s licensing presented several problems. Like the trials of all childhood vaccines, they did not use a proper placebo control. Instead, the control used in the trial included bioactive ingredients—in fact, all the ingredients in the RotaTeq vaccine itself.
In 2018, when the Informed Consent Action Network (ICAN) reviewed Merck’s package insert for the RotaTeq vaccine, it discovered that the insert claimed the control was a “placebo.” Corroboration of this claim proved impossible, however, since the FDA’s clinical trial review had redacted the ingredients of this “placebo.”
So, on behalf of ICAN, attorney Aaron Siri’s law firm, Siri & Glimstad, LLP, submitted a Freedom of Information Act (FOIA) request to the FDA, asking for “[d]ocuments sufficient to identify the ingredients of the ‘placebo’ in the prelicensure clinical trials identified in Section 6.1 of the package insert for RotaTeq.”
On June 14, 2018, the FDA answered the FOIA request. The documentation it provided listed polysorbate-80, sodium citrate, sodium phosphate, and sucrose as the bioactive ingredients used in the “placebo.” Yes, the very same ingredients found in RotaTeq!
The RotaTeq clinical trial data also noted that the children in both test groups were allowed to receive routinely recommended vaccines at the same time—a confounding variable that made the trial data even more worthless. These routine vaccines included COMVAX for hepatitis B (HepB) and haemophilus influenzae type b (Hib), INFANRIX (a DTaP vaccine), IPOL (an inactivated polio vaccine), and PREVNAR (a pneumococcal vaccine).
The clinical data acknowledged that the incidences of “diarrhea, vomiting, otitis media (ear infection), nasopharyngitis, and bronchospasm were statistically higher among infants in the RotaTeq group versus those in the placebo control group.” It also acknowledged other serious adverse events, including”seizures, urinary tract infections, gastroenteritis, bronchiolitis, pneumonia, and pyrexia.”
The FDA’s conclusion (which we will return to later) is worth emphasizing:
Rotavirus is a universal childhood disease; however it is not universally severe in U.S. children. Data suggest there are groups at higher risk to develop severe rotavirus gastroenteritis requiring hydration in the emergency room or inpatient hospital setting. It would be optimal if one could effectively target a rotavirus vaccine program toward those who would most benefit. However, the characteristics of these infants at higher risk to develop complications from rotavirus infection include factors such as prematurity, low birth weight, being born to a low income and/or young mother and other socio-economic factors which may be difficult to easily capture in a rotavirus vaccine delivery program. [Emphasis added.]
The FDA would add a specific note on “risks” associated with intussusception:
In the phase 3 clinical trials for this product, the risk of intussusception was not increased relative to placebo within 42 days of any vaccine dose; but the risk was not zero. The potential risk of developing a serious adverse event from the vaccine, such as intussusception, must be weighed against the benefit derived from a vaccine that prevents a disease that is not severe in most U.S. children. [Emphasis added.]
The “not zero” caveat would prove to be prophetic. By 2015, reports from VAERS, which is known to substantially underreport adverse events, listed over 1,500 cases of intussusception and 10 deaths associated with Merck’s RotaTeq vaccine.
RotaTeq’s product insert, too, raised red flags:
In a post-marketing study, cases of intussusception were observed in temporal association within 21 days following the first dose of RotaTeq, with a clustering of cases in the first 7 days.
In February 2008, the FDA’s VRBPAC panel added, in an 11-to-1 vote, a third rotavirus vaccine to the mix—this one GlaxoSmithKline’s ROTARIX, a genetically engineered vaccine made of live-attenuated human rotavirus strains.
As was the case with Merck’s RotaTeq, children in the control group of the clinical trials for GSK’s ROTARIX did not receive a proper placebo. Instead, the control group received an oral drop that included dextran, sorbitol, amino acids, Dulbecco’s Modified Eagle Medium (DMEM), and xanthan.
The package insert disclosed more deaths in the group receiving ROTARIX than in the group using the alleged placebo:
During the entire course of 8 clinical studies (Studies 1 to 8), there were 68 (0.19%) deaths following administration of ROTARIX (n = 36,755) and 50 (0.15%) deaths following placebo administration (n = 34,454).
The insert also described a study done at hospitals in Mexico. That study had evaluated the temporal association between vaccination with ROTARIX and intussusception. A notable increase in intussusception was observed among those vaccinated. But this potential connection was dismissed by the FDA:
The Mexico study did not take into account all medical conditions that may predispose infants to intussusception. The results may not be generalizable to U.S. infants who have a lower background rate of intussusception than Mexican infants.
In early March 2010, an independent research team identified components of extraneous virus—namely, DNA from porcine circovirus type 1 (PCV-1)—found in ROTARIX. Follow-up studies confirmed that viral components of the PCV-1 virus “have been present since the early stages of the vaccine’s development, including during clinical studies.”
As a result of that study, on March 22, 2010, the FDA issued a press release urgingclinicians and healthcare professionals to “temporarily stop using GlaxoSmithKline’s (GSK’s) ROTARIX rotavirus vaccine while [the FDA] investigates the presence of porcine circovirus 1 (PCV-1) in the product, a finding that isn’t currently thought to pose a safety risk.”
As if that news weren’t bad enough, in early May 2010 it was brought to the FDA’s attention that a porcine-derived material used in the manufacturing process caused DNA from two porcine circoviruses—PCV-1 and PCV-2—to be detected in Merck’s RotaTeq.
Unlike PCV-1, PCV-2 is a lethal pig virus that causes immune suppression and a serious wasting disease in baby pigs. PCV-2 damages the piglets’ lungs, kidneys, reproductive system, and brain, and it ultimately causes death.
The FDA swiftly pulled together a meeting on May 7, 2010. Its purpose: “to discuss the findings of PCV and PCV DNA in rotavirus vaccines.”
After the meeting, the regulators wrote:
Based on a careful evaluation of this information, a thorough review of the scientific literature, and input from scientific and public health experts, the Agency is revising its recommendation to temporarily suspend use of the ROTARIX vaccine. FDA has determined it is appropriate for clinicians and healthcare professionals to resume the use of ROTARIX and to continue the use of RotaTeq.
A week later, on May 14, 2010, the FDA announced that it had reviewed the scientific evidence and determined that both vaccines were safe and that use of the products should continue. As a result, it lifted the suspension of ROTARIX and assured the public that “PCV-1 and PCV-2 are not known to cause disease in humans.”
To date, PCV-1 and PCV-2 continue to contaminate RotaTeq vaccines. And, to date, PCV-1 continues to contaminate ROTARIX vaccines.
The Curious Case of Rotavirus Vaccines in India
There is no better place to have an impact than India. — Bill Gates, Huffington Post (02.10.2012)
In 2011, the British daily newspaper The Times reported that GlaxoSmithKline would link up with the Global Alliance for Vaccines and Immunization (GAVI) with the intent of selling over 100 million doses of ROTARIX to the Indian government over a five-year period.
GAVI was founded in 2000 by the Bill and Melinda Gates Foundation (BMGF) with assistance from the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), the Rockefeller Foundation, UNICEF, the World Bank Group, the World Health Organization (WHO), and national governments of donor and developing countries. Now called Gavi, The Vaccine Alliance, its mission is “to shape vaccine markets” and “to save lives and protect people’s health by increasing equitable and sustainable use of vaccines.”
BMGF, better known as simply “the Gates Foundation,” has long had a robust presence in India. Or, to put it more bluntly, BMGF is an expert at leveraging public-private partnerships for its benefit while foisting unnecessary and dangerous vaccines on underdeveloped nations.
Someone who agrees with that candid assessment of BMGF is Sandhya Srinivasan, consulting editor of Indian Journal of Medical Ethics, who in 2014 remarked:
[BMGF] is funding the development of, and actively promoting, a rotavirus vaccine. In all these efforts, BMGF has consistently disregarded serious concerns raised by senior public health professionals regarding these vaccines’ relevance, public health value, safety, and cost/affordability for India, as well as the ethics related to their trials.
Andrew Witty, who served as chief executive for GlaxoSmithKline between 2008 and 2017, told The Times that GSK would be offering vaccines to India at a reduced cost as “a concerted strategy to change their business model.”
In July 2012, GSK issued advertisements announcing that babies in India were dying from rotavirus, prompting India’s financial magazine Moneylife to ask, “Is the pharmaceutical industry trying to create an opportunity for making money by hard-selling new vaccines to parents by creating a false scare about the disease?”
The same year, Dr. Nalini Abraham, a Delhi-based medical practitioner, objected to the broadcasting of TV advertisements featuring rotavirus vaccinations. She filed an official complaint with the Advertising Standards Council of India (ASCI), alleging that “GSK’s advertisement, shown on local television channels, wrongly claimed that vaccination is the only way to reduce the incidence of rotavirus infections.”
In response to her complaint, GSK claimed its statements were “substantiated by scientific studies conducted by global health authorities such as Centre for Disease Control and the Global Alliance for Vaccine and Immunization.”
After reviewing the case, a panel representing the Consumers Complaints Council of India arrived at the conclusion that “the claim of vaccination being the only way to reduce incidents of infection and the only way to treat rotavirus was inadequately substantiated and misleading.”
The panel upheld the complaint filed by Dr. Abraham, and GSK was no longer allowed to broadcast direct advertisements to the public.
From this entire episode we ascertain that GSK was wittingly frightening parents with manipulative marketing tactics and misleading “public service announcements” in order to create a market for its vaccine.
Afterwards, India made an effort to circumvent controversies surrounding imported vaccines from pharmaceutical giants by embarking upon a campaign to create a homegrown rotavirus vaccine—or so it seemed on the surface.
The back story is as follows: On March 9, 2015, India launched ROTAVAC 116E, advertised as an indigenous rotavirus vaccine—”the first of its kind in the developing world seeking to end the era of costly imported ones.”
But ROTAVAC 116E had already been called out for serious problems during clinical trials—called out, that is, only after hard-to-obtain trial data was made public. Significant portions of the trial data were kept secret, even from the Indian government.
Citing Phase 3 trial data, Jalaj Bajaj published a letter in 2015 in the trade journal Vaccine, pointing out:
[T]he vaccine was tested in only 6,719 infants (4,532 received vaccine; 2,187 were controls). Ultrasound evidence of intussusception was found in 17 who had received the 116E vaccine and in 6 babies receiving placebo. This is 5 to 10 times higher than the risk of intussusception with the RotaShield vaccine (which was withdrawn from the market) and nearly 70 times higher than the risk of intussusception with the current, internationally licensed vaccine, RotaTeq.
One year earlier, in a 2014 letter to the editor of the journal Vaccine, Jacob Puliyel, a consultant pediatrician at St. Stephen’s Hospital in Delhi, remarked, “The risk of intussusception in the 116E trial was three times higher than with the RotaShield trial.” Puliyel highlighted the fact that in 50% of the cases there is “a need for urgent treatment by a radiologist or pediatric surgeon. In remote parts of India, without motorable roads, let alone radiologists and pediatric surgeons, mortality will be near 100%.”
A Clinical Trials-registered study protocol promised to conduct specific studies of three doses of ROTAVAC 116E among vaccinated and placebo recipients in three Indian cities (Delhi, Pune, and Vellore), starting in March 2011. The purpose was to track incidence of intussusceptions.
But the data from those studies were never provided in full, despite numerous requests and a petition calling for release of “the segregated data from Vellore for vaccinated and control where the intussusceptions cases were highest.”
In a subsequent comment made in Age of Autism, Puliyel, who is also a member of the National Technical Advisory Group on Immunisation (NTAGI), remarked on the importance of the withheld data:
Peer-reviewed journal Vaccine published a letter written by me and a colleague, asking for disaggregated data on the number of intussusceptions in Vellore in the randomized control trial during the 2-year study period. The protestation of the authors that the vaccine is safe has little meaning if they do not provide the data. However, the data is not available in the papers published and the peer reviewer of Vaccine and the Editor of this international journal felt that it needs to be provided.
It also turned out that the development of ROTAVAC 116E was far from an indigenous project spontaneously created for the welfare of children in India. On the contrary, it was revealed that the vaccine, “the first of its kind in the developing world,” was a joint venture that began with seed money provided by the NIH and the US Agency for International Development (USAID).
Here’s how the project really started: In 1998, Dr. Kate Aultman, the National Institute of Allergy and Infectious Diseases (NIAID) project officer, hosted a meeting in Bangalore to bring investigators of candidate vaccines together with a group of Indian vaccine manufacturers. The meeting was presided over by then-US Secretary of Health Donna Shalala.
In 1999, the Gates Foundation gave a $25 million grant to the global health organization PATH for vaccine introduction in the Indian state of Andhra Pradesh. A quarter of that grant—$6 million—was given to Hyderabad-based Bharat Biotech International Ltd. to develop rotavirus programs, even though the company had never made a single vaccine.
To get up to speed, key laboratory staff members for Bharat Biotech were trained at the CDC by Dr. Jon Gentsch. Advisors from the NIH assisted them with general clinical practices and data management.
The patent for 116E, the alleged virus strain upon which the Indian vaccine would be based, was held by the US Department of Health and Human Services (HHS). Dr. Getsch and Dr. Roger Glass were two of the patent holders.
Dr. Glass would later pen an article in commemoration of the 25th anniversary of the Indo–US Vaccine Action Program (VAP). In it, hehighlighted the contributions the Gates Foundation made to the rotavirus vaccine project, noting:
This project could not have advanced without the help of many people and institutions. We have to acknowledge the steadfast support of Bill and Melinda Gates who recognized the importance of rotavirus early on and committed funds for this project from the beginning of its commercial development through the pivotal trials.
To be fair, a paper released in 2020 seemed to clear ROTAVAC of any association with intussusception. Citing surveillance studies done in India on 970 infants with intussusception between 2016 and 2019, the study concluded, “The rotavirus vaccine produced in India that we evaluated was not associated with intussusception in Indian infants.”
In addition to certain methodological problems that might not give assurance to the credibility of the paper, another glaring problem stood out: the study was, “[s]upported by a grant (OPP1165083) from the Bill and Melinda Gates Foundation.”
A Company Man- Paul Offit and the Rotateq Vaccine
It is difficult to get a man to understand something, when his salary depends on his not understanding it. – Upton Sinclair
No article about shady clinical trials, backroom handshakes, moneyed interests and the pharmaceutical machinations involved with rotavirus vaccines is complete without an account of the close connection between pediatrician Paul Offit and Merck’s RotaTeq vaccine.
Dr. Offit is currently director of the Vaccine Education Center at the Children’s Hospital of Philadelphia (CHOP) and professor of pediatrics in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.
He also holds the Maurice R. Hilleman Chair in Vaccinology at the Perelman School of Medicine at the University of Pennsylvania. The position was created in honor of the former senior vice president of Merck and, not incidentally, with a $1.5 million dollar grant from Merck.
Offit served as a member of the CDC’s advisory committee, ACIP, from 1998 to 2003. During his five years on that panel, he voted favorably on three rotavirus issues. One of those issues was the recommendation to add the rotavirus vaccine to the Vaccines for Children program. At the time, Offit shared ownership of a patent for a rotavirus vaccine being developed under a grant from Merck.
Preceding his appointment to ACIP, Offit received two rotavirus patents, the first on May 6, 1997, and the second on May 12, 1998. During his ACIP tenure, Offit received two additional patents in 2000 and 2001.
According to a June 15, 2000, congressional investigation held on conflicts of interest and vaccine development,it was publicly revealed that “Dr. Paul Offit disclosed that he holds a patent on a rotavirus vaccine and receives grant money from Merck to develop this vaccine.”
Offit rejected the accusation that his personal stake in the patent would conflict with his ability to evaluate the safety of that product. Yet he openly admitted, “I am a co-holder of a patent for a (rotavirus) vaccine. If this vaccine were to become a routinely recommended vaccine, I would make money off of that.”
The vaccine Offit was referring to is Merck’s RotaTeq. Besides Offit, RotaTeq’s other patent owners were his employer, The Children’s Hospital of Philadelphia (CHOP); Dr. H. Fred Clark, a scientist at that hospital; and legendary vaccinologist Dr. Stanley Plotkin. Offit controlled 100% of CHOP’s inventor rights. Thus, when CHOP sold its stake in RotaTeq in 2008, Offit profited handsomely.
A 2009 article in Wired quotes Offit admitting that he received a payout of “several million dollars, a lot of money” when CHOP sold its stake in RotaTeq for $182 million and that he collects annual royalties on RotaTeq. Though he has refused to disclose the exact amount of his windfall, Offit told Newsweek reporter Claudia Kalb, “[I]t’s like winning the lottery.”
In their 2009 article “Voting Himself Rich: CDC Vaccine Adviser Made $29 Million Or More After Using Role to Create Market,” Age of Autism editors Dan Olmsted and Mark Blaxill calculated that Offit made somewhere between $29 million and $55 million from his stake in the RotaTeq vaccine.
Olmsted and Blaxill made an indispensable observation on how vaccine markets are created:
Unlike most other patented products, the market for mandated childhood vaccines is created not by consumer demand, but by the recommendation of an appointed body called the Advisory Committee on Immunization Practices (ACIP). In a single vote, ACIP can create a commercial market for a new vaccine that is worth hundreds of millions of dollars in a matter of months. For example, after ACIP approved the addition of Merck’s (and Offit’s) RotaTeq vaccine to the childhood vaccination schedule, Merck’s RotaTeq revenue rose from zero in the beginning of 2006 to $655 million in fiscal year 2008.
An unabashed Offitt defended his takings:
I’m not embarrassed about it. It was the product of a lot of work, although it wasn’t why I did the work, nor was it, frankly, the reward for the work.
Would it surprise readers to learn that, in addition to his duties as chief spokesman for his patented vaccine, Offit also happens to be a routinely cited go-to “expert” on vaccines for the mainstream media and one of the most widely quoted defenders of vaccine safety?
In a 2015 New York Times opinion piece titled “What would Jesus do about the measles?, “Offit asserted that parents who choose not to vaccinate are “martyring their children.” He even intimated that, were Christ Jesus alive today, he would likely advocate for forcibly vaccinating children against their parents’ will.
But it is not unseemly enough that Offit is the embodiment of conflict of interest. Besides being a moral hazard, he also appears to invite controversy—and to positively relish it!
For example, in June 2008 talk addressing the question “Are Childhood Vaccines Safe,” Offit made this wild claim:
I think conservatively, one could say that, based on their caveats, that one could probably respond to about 100,000 different vaccines at one time. . . . I would say you probably could get 100,000 vaccines every day.
It is a mystery why his fellow “scientists” and consumers of his product do not demand that Offit offer evidence to support such an outlandish proposition.
Summary
“The vaccination lobby shamelessly takes all the children of this world as hostages to still their greed for money and power. They relentlessly abuse our compassion for the weaker and our concern about health to promote their giga-business. No matter what. No matter how many more vaccine victims will suffer death or side-effects. No matter how many financial resources this strategy devours at the expense of essential social investments like housing and employment. No matter what. Shocking! There is no excuse for this crime. Just as shocking is the observation that (health) policy is no longer under local, democratic control. Everything is set up and organised with scrutiny at the highest, international level by those who take profit from it: the pharmaceutical industry, the financial world, politicians.” – Kris Gaublomme, M.D. (The International Vaccination Newsletter, June 1998)
The labyrinthine history of rotavirus and the rotavirus vaccines is how the public is conditioned to believe there is a threat where there is none while the fundamental causal factors of disease are ignored or concealed.
The tautological “reasoning” that rotavirus causes diarrhea assumes that a microscopic anomaly found in a malady must be the cause of that disease rather than the result of numerous factors which create the conditions for that disease.
In the developed world, mortality is rarely seen in cases of gastrointestinal irritation. Most cases of chronic diarrhea are indications that something that was ingested cannot be digested.
Examples include certain indigestible proteins that impair the proper functioning of the colon. Food that is not properly assimilated is rapidly eliminated while still in its watery state.
Excessive feeding of starchy foods to infants can also be problematic as the necessary digestive enzymes for proper digestion of starches are not present in functional quantities until around six months of age for most infants.
Infants fed inappropriate diets or just overfed can have their digestive systems turned into an ecological mess. Fortunately, poor nutrition can be treated inexpensively through dietary changes to restore intestinal flora.
Misdiagnoses may also lead some pediatricians to prescribe anti-diarrhea medications or opiates. Certain medications and bactericides like antibiotics or penicillin can prevent normal bowel functioning. Antibiotics may kill certain intestinal microorganisms while allowing competing strains to flourish which could lead to dehydration and even damage to the intestine.
In the underdeveloped world, chronic gastroenteritis is primarily a condition created by dirty drinking water, poor sanitary conditions, and malnutrition.
Infants in the Third World, and in some areas of the U.S., face the daily reality of drinking water that contains excessive biological waste and/or chemical toxins.
About 1.2 billion people do not have safe, clean water to drink. Twice as many do not have adequate sanitation. Hundreds of millions suffer repeated, enervating bouts of diarrhea due to these conditions.
Protestations from compromised scientists, health bureaucrats and industry executives aside, it is not vaccines that the Third World needs to prevent severe diarrhea. What they need is the basics: clean drinking water, better nutrition, proper housing, and improved sanitation.
These are not solutions many governments seem motivated to address and not the reality that the Pharmaceutical Industry wants the public to hear.
Both governmental agencies and the pharmaceutical industry control the direction of public health policy and treat vaccination as the solution for what are profound political and social problems.
There are many lessons within the rotavirus saga, foremost is how drug companies manufacture a disease to frighten parents as a means to create a market out of thin air.
Our next installment, Part 3 of our 14-part series, examines the DTaP vaccines.
