A Brief History of the ‘Antivax’ Movement

It is often assumed that the ‘anti-vax’ movement began with Andrew Wakefield, and ‘that autism study’, or former Playboy model Jenny McCarthy’s claims that her son’s autism was caused by vaccination.

But did these two events really cause tens of thousands of parents to begin questioning vaccines and getting embroiled in bitter skirmishes on social media? Personally, I had never heard of Andrew Wakefield, or Jenny McCarthy, when I first began to delve into the vaccine subject, in early 2010.

Opposition to vaccination is not a new phenomenon – for as long as there have been vaccines, there has been fierce opposition. Originally focused in England, that opposition really gained momentum when the Compulsory Vaccination Act was passed in Victorian England, in 1853.

The main pockets of opposition to compulsory vaccination were among the working class, and the clergy, who believed it was ‘un-Christian’ to inject people with animal products [1].

The original Vaccination Act in 1840 had provided free vaccination for the poor, to be administered by the Poor Law guardians. This law, however, was a failure, as the “lower and uneducated classes” did not take up the offer of free vaccination [1].

The Compulsory Vaccination Act of 1853 went much further – it ordered all babies up to 3 months old be vaccinated (administered by Poor Law Guardians), and in 1867, this was extended up to 14 years of age, and penalties for non-compliance were introduced.

Doctors were encouraged to report non-vaccinators to the authorities, by “financial inducements for compliance and penalties for failure”. While the 1853 Act had introduced one-off fines or imprisonment, the 1867 Act strengthened this to continuous and cumulative penalties, so that parent’s found guilty of default could be fined continuously, with increasing prison sentences, until their child reached 14 years of age [2].

(As an interesting side-note here, the vaccination laws were not the only incursions of the state during this time, at the expense of personal liberty, and private bodily autonomy. The Contagious Diseases Acts of 1864, 1866, and 1869, stated that any woman suspected of prostitution was required to be medically inspected for venereal disease. If found infected, she was to be confined in hospital for treatment, with or without her consent. The Notification of Infectious Diseases Acts in 1889 and 1899 required that all contagious diseases – except tuberculosis, which is curious, since it was a major killer at the time – be reported to the local medical officer, who could then forcibly remove the patient to hospital, whether they consented or not [1].

Meanwhile, the vaccination laws were tightened yet further in 1871 (ironically, the same year that a large smallpox epidemic raged across Europe and England – no doubt testament to how ‘effective’ the compulsory laws had been!), making it compulsory for all local authorities to hire Vaccination Officers [2].

In response to these draconian measures, the Anti-Vaccination League was formed in England, and a number of anti-vaccine journals were started, which “included the Anti-Vaccinator (founded 1869), the National Anti-Compulsory Vaccination Reporter (1874), and the Vaccination Inquirer (1879)”.

Numerous other writings and pamphlets were distributed widely – for example, 200,000 copies of an open letter titled ‘Current Fallacies About Vaccination’, written by Leicester Member of Parliament, P Taylor, were distributed in 1883 [2].

The vaccination process itself was both painful and inconvenient, for parents and children alike. The vaccinator used a lancet (a surgical knife with sharp, double-edged blade) to cut lines into the flesh in a scored pattern. This was usually done in several different places on the arm. Vaccine lymph was then smeared into the cuts. Infants then had to be brought back eight days later, to have the lymph (pus!) harvested from their blisters, which was then used on waiting infants [1].

After the stricter 1871 amendments to the law, parents could also be fined 20 shillings for refusing to allow the pus to be collected from their children’s blisters, to be used for public vaccination [1].

By this time, severe and sometimes fatal reactions to the vaccine were being reported, and doubts began to grow about how effective the vaccine really was [3].

The town of Leicester was a particular hot-bed of anti-vaccine activity, with numerous marches and rallies, demanding for repeal of the law, and advocating other measures of containment, such as isolation of the infected. These rallies attracted up to 100,000 people [4].

The unrest and opposition continued for two decades, and an estimated 6000 prosecutions were carried out, in the town of Leicester alone [3].

The following excerpts from the Leicester Mercury bears witness to the deep convictions held by those who refused to submit to the mandatory measures:

“‘George Banford had a child born in 1868. It was vaccinated and after the operation the child was covered with sores, and it was some considerable time before it was able to leave the house. Again Mr. Banford complied with the law in 1870. This child was vaccinated by Dr. Sloane in the belief that by going to him they would get pure matter. In that case erysipelas set in, and the child was on a bed of sickness for some time. In the third case the child was born in 1872, and soon after vaccination erysipelas set in and it took such a bad course that at the expiration of 14 days the child died“.

Mr Banford was fined 10 shillings, with the option of seven days imprisonment, for refusing to subject a fourth child to the vaccine [5].

And again…‘By about 7.30 a goodly number of anti-vaccinators were present, and an escort was formed, preceded by a banner, to accompany a young mother and two men, all of whom had resolved to give themselves up to the police and undergo imprisonment in preference to having their children vaccinated. The utmost sympathy was expressed for the poor woman, who bore up bravely, and although seeming to feel her position expressed her determination to go to prison again and again rather than give her child over to the “tender mercies” of a public vaccinator. The three were attended by a numerous crowd and in Gallowtreegate three hearty cheers were given for them, which were renewed with increased vigour as they entered the doors of the police cells [6]”.

Eventually, there were so many vaccine refusers in the town of Leicester, that some local magistrates and politicians declared their support for parental rights, and encouraged their peers to do the same [3].

The law was finally relaxed in 1898, when new laws were passed, that allowed for conscientious objection to vaccination [7]. By the end of that same year, more than 200,000 certificates of conscientious objection had been issued, most among the working class, and many were women. [1]

Meanwhile in the United States, smallpox outbreaks in the late 1800’s led to vaccine campaigns, and subsequent opposition in the formation of The Anti-Vaccination Society of America in 1879, followed by the New England Anti Compulsory Vaccination League in 1882, and the Anti Vaccination League of New York City in 1885 [4].

The homeless and the itinerate were blamed for spreading smallpox, and in 1901, the Boston Board of Health ordered ‘virus squads’ to vaccinate men staying in cheap boarding rooms – by force [8].

Following a smallpox outbreak in 1902, the Cambridge Board of Health in Massachusetts mandated vaccination for all city residents. This led to possibly the most important, and controversial, judicial decision regarding public health.

One man, Henning Jacobson refused to comply with the mandate, on the grounds that it violated his right to care for his own body as he saw fit. The city filed criminal charges against him, which he fought, and lost, in court. He then appealed to the US Supreme Court, which ruled in the State’s favour in 1905, giving priority to public health over individual liberty [9].

The ‘anti-vaxxers’ have never really gone away in the intervening years, although sometimes they have been more vocal than others, such as in the 1970’s, when there was controversy throughout Europe, North America and Britain, about the safety and possible side effects of the diptheria-tetanus-pertussis vaccine [10].

In 1998, the vaccination argument again came to the forefront, with Andrew Wakefield’s case series published in the Lancet. Although the report was looking at a link between autistic disorders and bowel dysfunction, it mentioned in its conclusion that a number of parents believed their child’s symptoms began after MMR vaccination [11]. The authors felt this potential link deserved more investigation…

The furore and the fall-out are still ongoing. Wakefield was found guilty of failing to get proper ethics approval for the study, and he and a fellow investigator were subsequently ‘struck off’. Wakefield’s fellow investigator later challenged the decision, and won [12]. And while a number of researchers later confirmed the original findings, of bowel dysfunction in autistic children [13-16], Wakefield’s reputation and career have been left in tatters – the subject of mockery and derision.

Anybody who confesses to have doubts about the safety of efficacy of vaccines, as a general rule, get a taste of the same scorn and derision that Andrew Wakefield has received.

Even in the era of smallpox vaccination, the media tended to portray anti-vaxxers in a less-than-flattering light. At the time, the media referred to the debate as a “conflict between intelligence and ignorance, civilization and barbarism [9].

So, are anti-vaxxers really anti-science?

Not so, says…science.

In 2007, Kim et al analysed vaccination records of 11,680 children from 19 – 35 months of age, to evaluate maternal characteristics that might influence whether the child was fully vaccinated, or not.

They found that mothers with tertiary degrees and high incomes were the least likely to fully vaccinate their children, while mothers in poor minority families without high school diplomas were the most likely to fully vaccinate their children [17].

Similarly, a study in 2008 that investigated the attitudes and beliefs of parents who decided to opt out of childhood vaccine mandates, found that they valued scientific knowledge, were adept at collecting and processing information on vaccines, and had little trust in the medical community [18].

In 2017, the Australian Institute of Health and Welfare released their latest figures on vaccination rates. The national average was 93% of children fully vaccinated, yet in Sydney’s upmarket (ie. Highly educated, high income-earning professionals) inner suburbs and northern beaches, as few as 70% of children under 5 were fully vaccinated [19].

The same story was repeated in Melbourne, with the wealthiest – and by association, better educated – suburbs having the lowest vaccination rates. There was an ironic, and rather telling, opening paragraph in The Age, when reporting these figures: “Four of the wealthiest, healthiest suburbs of Melbourne have the worst child vaccination rates in the state [20]

(It does beg the question: Were they not vaccinated because they were healthy…or were they healthy because they were not vaccinated?)

Statistics gathered from Canada tell a similar story – a higher percentage of anti-vaxxers held a university degree, compared to the national average [21].

It seems that doctors and paediatric specialists are not always in agreement with current vaccine practice either – at least, not when it comes to their own children:  “Ten percent of paediatricians and 21% of paediatric specialists claim they would not follow [CDC] recommendations for future progeny. Despite their education, physicians in this study expressed concern over the safety of vaccines [22]”.

With the vaccine schedule becoming increasingly crowded, and governments moving ever towards compulsory vaccination, the anti-vaccination movement is again gathering momentum. Increasing numbers of parents are delaying, declining, or opting for alternative vaccine schedules [23-24].

Around the world, as vaccine scepticism is on the rise, history looks set to repeat, as governments are becoming increasingly more forceful in trying to curb the sentiment. Only time will tell how this round will play out…

References:

[1] Durbach, N. They might as well brand us: Working class resistance to compulsory vaccination in Victorian England. The Society for the Social History of Medicine, 2000, 13:45-62.

[2] Porter D, Porter R. The politics of prevention: anti-vaccinationism and public health in nineteenth-century England. Med Hist. 1988;32(3):231-52.

[3] Williamson S. Anti-vaccination leagues: One hundred years ago, Arch Dis Child, 1984, 59: 1195-1196.

[4] Wolfe, R.M., Sharpe, L.K. Anti-vaccinationists past and present. BMJ. 2002d;325:430-432.

[5] Leicester Mercury, 10th March, 1884.

[6] Leicester Mercury, 10th June, 1884.

[7] Wohl A. Endangered Lives: Public Health in Victorian Britain, 1984, Methuen, London, pp. 134-135.

[8] ] Albert, M., Ostheimer, K.G., Breman, J.G. The last smallpox epidemic in Boston and the vaccination controversy. N Engl J Med. 2001;344: 375-379.

[9] Gostin, L. Jacobson vs. Massachusetts at 100 years: Police powers and civil liberties in tension. AJPH. 2005;95:576-581.

[10] Baker, J. The pertussis vaccine controversy in Great Britain, 1974-1986. Vaccine. 2003;21:4003-4011.

[11] Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive development disorder in children, Lancet, 1998, 3519103): 637-641.

[12] Professor John Walker Smith vs General Medical Council [2012] EWHC 503, http://www.eastwoodslaw.co.uk/wp-content/uploads/2013/03/Walker-Smith.pdf. Accessed September, 2017.

[13] Horvath K, Medeiros L, Rabszlyn A, et al. High prevalence of gastrointestinal symptoms in children with autistic spectrum disorder (ASD). J Pediatr Gastroenterol Nutr 2000, 31:S174.

[14] Horvath K and Perman JA. Autistic disorder and gastrointestinal disease, Current Opinion in Pediatrics 2002, 14:583-587

[15] Ashwood P, Anthony A, Torrente F, Wakefield AJ. Spontaneous mucosal lymphocyte cytokine profiles in children with regressive autism and gastrointestinal symptoms: Mucosal immune activation and reduced counter regulatory interleukin-10. Journal of Clinical Immunology. 2004:24:664-673.

[16] Torrente F, Anthony A, Heuschkel RB, et al. Focal-enhanced gastritis in regressive autism with features distinct from Crohn’s and helicobacter pylori gastritis. Am. J Gastroenterol. 2004;4:598-605.

[17] Kim SS, Frimpong JA, et al. Effects of maternal and provider characteristics on up-to-date immunization status of children aged 19-35 months. Am J Public Health, 2007, 97(2): 259-266.

[18] Gullion JS, Henry L, Gullion G. Deciding to opt out of childhood vaccination mandates. Public Health Nurs, 2008, 25(5): 401-408.

[19] Aubusson K, Butt C, Sydney postcode has Australia’s worst vaccination rate for five year old children, Sydney Morning Herald, 8th June, 2017.

[20] Butt C, Spooner R, Melbourne vaccination data: immunisation rates not improving in wealthy inner-city suburbs, The Age, 7th June, 2017.

[21] Chai C, Who are the anti-vaxxers in Canada? New poll profiles resistant group, Global News, 9th March, 2015.

[22] Martin, M. and Badalyan, V, Vaccination practices among physicians and their children. Open Journal of Pediatrics, 2012, 2:228-235.

[23] McCauley MM, Kennedy A, Basket M, Sheedy K. Exploring the choice to refuse or delay vaccines: a national survey of parents of 6- through 23-month olds, Acad Pediatr, 2012, 125): 375-383.

[24] Robison SG, Groom H, Young C. Frequency of alternative immunization schedule use in a metropolitan area, Pediatrics, 2012, 1301): 31-38.

Stranger Than Fiction: Polio ‘Treatments’ in the 1900’s

There’s no doubt whatsoever that the polio epidemics of the early 20th century left a traumatic and lasting impression on the American psyche (and perhaps to a lesser extent, the Western psyche). Everybody seems to know somebody who was ‘crippled by polio’. The fear and devastation were very real indeed.

Others have written excellent, in-depth analyses on what caused sporadic cases to become widespread and disabling epidemics, but few have delved into the reality of medical care exacerbating the severity of poliomyelitis.

Below are some of the treatments you could expect, if stricken by paralysis in the early 1900’s:

  • Intramuscular injections of strychnine (which can cause paralysis and nerve damage – if it doesn’t kill you outright) [1].
  • Lumbar punctures, which can cause or exacerbate paralysis, and also precede respiratory problems (which would have been blamed on ‘bulbar’ polio) [1].
  • Intraspinal injections of adrenaline (almost half of the recipients died), human serum, or quinine and urea hydrochloride (3 of 6 children given this mixture orally and intramuscularly died). Even intraspinal injections of horse serum were tried [1].
  • Injections of tetanus antitoxin – the rationale being that “tetanus, rabies and poliomyelitis all attacked nerve cells, so perhaps giving the antitoxin would block access to absorption sites on the cells”. Even injections of diptheria antitoxin were tried, with 3 out of 5 patients dying [1].
  • Tendon cutting and transplantation [2].
  • Painful electrical treatments [2].
  • Radium water (After radium was discovered in 1898, it quickly gained popularity, proclaimed as a ‘cure-all’ elixir that could make one young again, and cure all kinds of ills and ails) [3].
  • Surgical Straightening: Dr. John Pohl, in an interview circa 1940, said “We’d take the children to the operating room in those days, straighten them out under anaesthetic, and put them in plaster casts. When they woke up, they screamed. The next day they still cried from the pain. That was the accepted and universal treatment virtually all over the world. I saw it in Boston and New York City and London” [4].
  • Even laypeople had their ‘cures’ and remedies, and some saw it as too good an opportunity to pass up. During the deadly 1916 epidemic, the New York Times reported that one Joseph Frooks had been charged with selling ‘Infantile Disease Protector’, which, upon investigation, was found to contain “a mixture of wood shavings” that were saturated in a mixture smelling remarkably like naphthalene [5].

It behoves us to ask…how many people were disabled or killed by polio – and how many by the so-called ‘treatments’ for polio?

References:

[1] Wyatt HV, Before the Vaccines: Medical Treatments of Acute Paralysis in the 1916 New York Epidemic of Poliomyelitis, The Open Microbiology Journal. 2014, 8:144-147.

[2] Paul JR. A History of poliomyelitis, Yale University Press, New Haven, Connecticut, 1971.

[3] Gould T, A Summer Plague: Polio and its Survivors, Yale University Press, 1997.

[4] Cohn V. Sister Kenny: The Woman Who Challenged the Doctors, University of Minnesota Press, 1975.

[5] Ibid See reference 3.

The Next Vaccine For Pregnant Women

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In case you hadn’t heard, there’s a new vaccine that will likely be marketed toward pregnant women within the next couple of years. It’s for Respiratory Syncytial Virus (RSV) in the newborn – a common cold-like illness that is usually mild in healthy people. Nearly all children will have had an infection by their second birthday – according to the CDC, and of those who have an infection before 6mths of age, around 1-2% will be hospitalised, due to complications such as bronchiolitis or pneumonia [1].

The quest for an RSV vaccine actually began decades ago, and it had disastrous beginnings.

In the early 1960’s, an RSV vaccine, propagated on human embryonic kidney cells, and passaged through monkey cells, before being inactivated with formalin, and adjuvanted with aluminium, was trialled on infants, with disastrous results. Up to 80% of vaccinated infants were hospitalized with severe lower-respiratory infections, and two babies died [2].

It took scientists nearly four decades to figure out why the vaccine had such tragic results – which just goes to show how little is understood about the very system they seek to tamper with. It was due to “Lack of antibody affinity maturation followed poor Toll-like receptor stimulation”, according to the paper, published in Nature journal, in 2009 [3].

The quest for an RSV vaccine resumed with gusto.

At the forefront of the charge for an RSV vaccine, is Novavax, a biotechnology company with several products currently in the clinical testing stages. Following the announcement of positive results of Phase 2 clinical trials in older adults, in 2015, CEO of Novavax, Stanley Erck declared their RSV vaccine could be “the largest selling vaccine in the history of vaccines in terms of revenue”[4].

Unfortunately, the Phase 3 trial in older adults failed to show efficacy, and the company lost more than $1.5 billion in market value within hours of the announcement, as disappointed investors pulled their money [5].

This gives us some idea of the intense pressure faced by companies to deliver the next new ‘blockbuster’ vaccine. For a company like Novavax, with no products on the market yet, (just the potential of new products), investor confidence is crucial to financing the lengthy clinical trial and regulatory approval process.

Novavax then turned their attention to pregnant women, and in February 2019, announced favourable results (actually, not as favourable as they were hoping for, but nevertheless, they found a way to put a positive spin on them) from a Phase 3 clinical trial on pregnant women. The vaccine, called ‘Resvax’, is not only aluminium adjuvanted, it is also genetically-engineered with nano-particles. The press release stated “Our next steps include meeting with U.S. and European regulators to review these data and to discuss the path forward for licensure” [6].

The trials on pregnant women were funded in part, by an $89 million grant from the Bill and Melinda Gates Foundation, with the stated purpose “to advance to WHO Pre-Qualification the development of a respiratory syncytial virus (RSV) vaccine for maternal immunization to reduce the burden of RSV disease in infants less than six months of age in developing countries”[7-8].

Obviously, the burden of RSV disease falls mainly on developing nations, however, it’s likely that a new RSV vaccine will also be targeted at pregnant women in western countries.

One of the main ways to prevent respiratory disease in infants is via breastfeeding. A study published in British Medical Journal found that among 115 babies who had been hospitalized for RSV infection, only 8 were breastfed [9].

Given that breastfeeding rates are vastly lower in developing countries, one wonders why $89 million (and more) wasn’t spent to increase maternal nutrition and breastfeeding rates. As an example, in West/Central Africa, only a mere 20% of infants are exclusively breastfed for the first six months of their life [10].

One of the main groups promoting the need for an RSV vaccine during pregnancy, is the Oxford Vaccine Group, who admit that almost all infant deaths due to RSV are in developing countries [11].

The director of Oxford Vaccine Group is Andrew Pollard, who holds several patents relating to vaccines [12-13], and is Chair of the UK Department of Health’s Joint Committee on Vaccination and Immunisation, and the European Medicine Agency’s scientific advisory group.

Another member of the Oxford Vaccine Group, Matthew Snape, has been Principal Investigator in clinical trials of numerous RSV vaccine candidates. He is also the Director of the National Immunization Schedule Evaluation Consortium (NISEC) [14].

It is also interesting to note that the CDC has held a patent for an RSV vaccine, since 2010 [15]. How will that affect any future decisions regarding RSV vaccinations being promoted to pregnant women?

References:

[1] CDC, Respiratory Syncytial Virus Infection (RSV), https://www.cdc.gov/rsv/high- risk/infants-young-children.html. Accessed March 2019.

[2] Dudas RA, Karron RA. Respiratory syncytial virus vaccines. Clin Microbiol Rev. 1998;11(3):430-9.

[3] Delgado MF, Coviello S, Monsalvo AC, et al. Lack of antibody affinity maturation due to poor Toll-like receptor stimulation leads to enhanced respiratory syncytial virus disease. Nat Med. 2008;15(1):34-41. [4] FierceBiotech, Novavax craters after phase III RSV F vaccine failure; seeks path forward, https://www.fiercebiotech.com/biotech/novavax-craters-after-phase-iii-rsv-f-vaccine-failure- seeks- path-forward. Accessed March 2019.

[5] CNBC, Novavax is down 80%. Here’s why its been really hard to develop an RSV vaccine, https://www.cnbc.com/2016/09/16/heres-why-its-been-really-hard-to-develop-a-vaccine-for- rsv.html. Accessed March, 2019.

[6] Novavax, Press Release: Novavax announces topline results from Phase 3 PrepareTM Trial of Resvax TM for prevention of RSV disease in infants via maternal immunization, http://ir.novavax.com/news-releases/news-release- details/novavax-announces-topline-results-phase-3-preparetm-trial. Accessed March 2019.

[7] Novavax, Bill & Melinda Gates Foundation, https://novavax.com/page/19/bill-and- melinda-gates-foundation. Accessed March 2019.

[8] Bill and Melinda Gates Foundation,How We Work, Grant: Novavax, Inc, https://www.gatesfoundation.org/How-We-Work/Quick-Links/Grants- Database/Grants/2015/09/OPP1127647. Accessed March 2019.

[9] Downham MA, Scott R, Sims DG, Webb JK, Gardner PS. Breast- feeding protects against respiratory syncytial virus infections. Br Med J. 1976;2(6030):274-6.

[10] UNICEF Progress for Children, Nutrition Indicators: Exclusive Breastfeeding, https://www.unicef.org/progressforchildren/2006n4/index_breastfeeding.html. Accessed March 2019.

[11] Oxford Vaccine Group: Vaccine Knowledge Project, Respiratory Syncytial Virus, http://vk.ovg.ox.ac.uk/rsv. Accessed April 2019.

[12] Justia Patents, Vaccine, https://patents.justia.com/patent/20130089571, Accessed April 2019.

[13] Justia Patents, Compositions comprising OPA Protein Epitopes, https://patents.justia.com/patent/20100183676. Accessed April 2019.

[14] Oxford Vaccine Group, Matthew Snape, https://www.ovg.ox.ac.uk/team/matthew-snape. Accessed April 2019.

[15] Anti-RSV Immunogens and methods of Immunization, https://patents.google.com/patent/US8846056?oq=vaccine+inassignee:centers+inassignee:f or+inas signee:disease+inassignee:control. Accessed April 2019.

Vaccines & Cancer: Is There a Connection?

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“On August 10th, 1998 our only child, Alexander, was diagnosed with the most common pediatric brain cancer, medulloblastoma. He was two years old. Our lives were shattered. The next six months became a race against time to try to understand the disease, find the appropriate treatment, and save Alexander.

After two brain operations Alexander recovered quickly. We wanted to give our son the most effective cancer therapy possible. After weeks of research, many conversations with parents who had children with brain cancer, and conversations with doctors from all over the world, we selected the Burzynski Clinic in Houston, Texas. We arrived there and incredibly we were turned away. Dr. Burzynski said he was not allowed to accept Alexander. I’ll never forget it. We sat in an examining room. Alexander was smiling at the doctor.

“Why can’t you take Alexander?” I asked Burzynski.

“The FDA dictates who I can and can’t accept,” Burzynski said.

Burzynski explained to us that the FDA would only allow him to accept children who had suffered through chemotherapy and/or radiation and still had “measurable tumor” left in their brains. Alexander hadn’t had either of these “world class treatments” but already endured two brain operations (16 hours of surgery in total) and was tumor free for the moment. He had paid a dear price to be tumor free. His optic nerves had been injured so that his big brown eyes were stuck pointing in opposite directions, he lost the ability to cry and laugh and he temporarily lost the ability to walk.

“Please accept my son. He’s only two years old. His whole life is in front of him. I know your treatment works. I’ve spoken to several parents whose children are here. They had malignant brain tumors like Alexander but now they’re alive and well. You have to treat my son,” I begged.

Dr. Burzynski said simply, “I am sorry but I can’t.” Burzynski was saddened but he was powerless. The FDA had made him turn away many children just like Alexander.

Chemotherapy was started soon after and Alexander died in my arms three months later.”

The above is part of written testimony to Congressman Dan Burton and the Government Reform Committee on Vaccines, held in 1999. The parents went on to outline a number of symptoms occurring after vaccines, that eventually led to a diagnosis of brain cancer. They believed his cancer was linked to the numerous rounds of vaccines he’d had as a baby [1].

They are not the only ones who suspect that vaccines played a part in causing cancer.

In 2001, a letter published in the Daily Mail, went as follows “My daughter had the MMR booster at four and her arm immediately swelled up and she started to feel unwell. Within six weeks, she was diagnosed as having leukaemia, and the doctors we spoke to accepted that the MMR jab was probably the trigger for the disease by overloading her immune system — though they believe she may have been already susceptible to the illness” [2].

It’s not just parent’s wondering. Some doctors and scientists, too, have obviously wondered.

In 1965, Dr. Michael Innis, an Australian pathologist and haematologist, wrote to The Lancet, and outlined how rates of leukemia in children at Brisbane Children’s Hospital between 1958 to 1964 showed a statistically significant association with diptheria-tetanus-pertussis vaccination [3].

In 1994, researchers found that MMR vaccination (among other things) increased the odds ratio of childhood acute lymphocytic leukemia [4].

Researchers in 2007 proposed a correlation between childhood leukemia and the introduction of widespread diptheria vaccination – “the significant peak-age (2–5 years) first appeared after 1940 in Great Britain. Since then, childhood leukemia has almost unchangeable incidence. In 1940 the introduction of immunization against diphtheria on a national scale was begun in Great Britain [5]”.

Nevertheless, the long-term studies required to prove whether vaccines increase cancer risk are not necessary for vaccine approval, nor does the CDC feel they are required…[6].

The following chart shows the incidence of childhood cancers in Australia [7].

Note that the most common age for childhood cancer is in the 0-4 years age group. Also note, that this is the same time period where the average child receives more than 40 different vaccines. The second most common age is in the 10-14 years age group, which coincides with the scheduled booster shots and HPV vaccines for secondary school. The least represented age group in cancer statistics, is the 5-9 years, which happens to coincide with a period where the average Australian child receives no vaccines, or, a yearly flu vaccine at the most [8].

It is also interesting to note that the most common type of cancer in children is acute lymphoblastic leukemia, or ALL [9]. This occurs when there is an overproduction of immature white blood cells in the bone marrow, which prevents the production of red blood cells [10]. It seems plausible that chronic activation of the immune system could potentially cause such a state of affairs – an hypothesis that has already been explored in the scientific literature [11-12]

I have already written here about the fact that excessive stimulation of humoral immunity (which includes antibody production – the aim of vaccination) results in suppression of cell-mediated immunity. This same immune system imbalance has already been shown to play a central role in facilitating tumour growth, invasion and metastasis [13].

In a study of oral cancer patients in Nigeria, those with cancer were found to have significantly higher levels of antibodies, than healthy controls [14]. Did the cancer cause the shift towards antibody production, or did the immune imbalance cause the cancer?

Actually, it was demonstrated as early as 1907, that an inappropriate immune response enhances tumour growth [15]. In the 1950’s, the phenomena of antibodies promoting tumour growth was labelled “immunological enhancement” [16].

Research published in the Journal of Infectious Diseases in 1988 found that one-year-old infants vaccinated with measles vaccine experienced a significant decrease in the level of alpha-interferon produced by lymphocytes. This marked reduction was still evident when the study ended a year later [17].

Interferons are a type of cytokine. These molecules communicate between cells to co-ordinate immune responses that help to expel pathogens. Interestingly enough, interferon therapy is now being used as a cancer treatment [18].

Now, obviously none of this proves that vaccines cause cancer, but until the CDC or others are convinced of the urgency of long-term studies in this area, we are left to surmise and hypothesize, and grieving parents are left to forever wonder. Given that the CDC has a large vested interest in vaccines, with dozens of vaccine-related patents [19]…it’s not likely to be anytime soon…

References:

[1] Testimony of Raphaele Moreau-Horwin & Michael Horwin, Government Reform Committee – Vaccines; Finding the Balance Between Public Safety and Personal Choice. US House of Representatives, 12th August 1999.

[2] Letter, Daily Mail, 25th Jan, 2001.

[3] Innis MD, Letter to the Editor: Immunization and Childhood Leukaemia, The Lancet, 13th March 1965, i605.

[4] Buckley JD, Buckley CM, Ruccione K, et al, Epidemiological characteristics of childhood acute lymphocytic leukemia. Analysis by immunophenotype. The Children’s Cancer Group, Leukemia, 1994, 8(5):856-864.

[5] Ivanovski P, Ivanovski I, Childhood acute lymphoblastic leukemia is triggered by the introduction of immunization against diphtheria, Medical Hypothesis, 2007, 68(2): 324-327.

[6] CDC, Parents Guide to Childhood Immunizations, Part 4: Frequently Asked Questions, https://www.cdc.gov/vaccines/parents/tools/parents-guide/parents-guide-part4.html. Accessed March 2019.

[7] Cancer Australia: Children’s Cancer Statistics, https://childrenscancer.canceraustralia.gov.au/about-childrens-cancer/statistics. Accessed September, 2017.

[8] Ibid

[9] St. Jude Children’s Research Hospital, Acute Lymphoblastic Leukemia (ALL), https://www.stjude.org/disease/acute-lymphoblastic-leukemia-all.html. Accessed March 2019.

[10] Poplack DG (1985) Acute lymphoblastic leukemia in childhood. In: Altman AJ (ed) The Paediatric Clinics of North America. Saunders Philadelphia, pp 669–697.

[11] O’Byrne KJ, Dalgleish AG. Chronic immune activation and inflammation as the cause of malignancy, Brit J Cancer, 2001, 85(4):473-83.

[12] Dalgleish AG, O’Byrne KJ. Chronic immune activation and inflammation in the pathogenesis of AIDS and cancer, Adv Cancer Research, 2002, 84:231-76.

[13] O’Byrne KJ, Dalgleish AG, Browning MJ, et al. The relationship between angiogenesis and the immune response in carcinogenesis and the progression of disease, Eur J Cancer, 2000, 36(2):151-69.

[14] Akinmoladun VI, Arinola OG, Elumelu-Kupoluyi T, Eriba LO. Evaluation of humoral immunity in oral cancer patients from a nigerian referral centre, J Maxillofac Oral Surg, 2013, 12(4):410-3.

[15] Flexner S, Jobling JW. Proceedings of the Society for Exp Bio Med. 1907. p. 461.

[16] Kaliss N. Immunological enhancement of tumor homografts in mice: a review. Cancer Res, 1958, 992-1003.

[17] Nakayama T, Maehara N, Sadaki K, Makino S. Long-term regulation of interferon production by lymphocytes from children inoculated with live measles virus vaccine, J Infect Dis, 1988, 158(6): 1386-1390.

[18] Cancer Research UK, Interferon (Intron A), https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/interferon. Accessed March 2019.

[19] Google search of vaccine-related patents held by CDC, https://www.google.com/search?tbo=p&tbm=pts&hl=en&q=vaccine+inassignee:centers+inassignee:for+inassignee:disease+inassignee:control&tbs=,ptss:g&num=100. Accessed March 2019.

Vaccines & Infertility

,

In 2012, the British Medical Journal published a case report of a 16-year-old girl who received a cervical cancer vaccine towards the end of 2008. Following that, her menstrual periods became irregular and scant, and by 2011, her menstrual cycle had ceased altogether.

Upon further inspection, it was discovered that all of her remaining eggs were dead – she was totally and irreversibly infertile, at just 16 years of age [1].

Other cases of premature ovarian failure in young women following vaccination for cervical cancer have since come before the courts [2].

A recent study (2018) analysed information representing 8 million 25-to-29-year-old US women between 2007 and 2014.

Approximately 60% of women who did not receive the HPV vaccine had been pregnant at least once, whereas only 35% of women who were exposed to the vaccine had conceived [3].

It is not just the HPV vaccine raising questions about possibly fertility effects. Research also shows increased risk of miscarriage after influenza vaccination during pregnancy [4]. [

Note that multi-dose vials of influenza vaccine still contain mercury in the form of thimerosal – the Chinese were using mercury as an abortifacient up to 5000 years ago [5].

Globally, the fertility rate has more than halved since 1960.

Fifty-nine countries, representing 46% of the global population, now have fertility rates below replacement level [6].

Of course, much of that has been by choice, through women’s rights movements, access to contraceptives, changing religious beliefs, along with increased living standards and higher education (not to mention a very aggressive ‘family planning’ push through WHO, Bill and Melinda Gates Foundation and others – more on that in a later post), but clearly not all of the plummeting fertility rate has been by choice…

An international team of scientists analysed data from nearly 43,000 men in dozens of industrialized countries and found that sperm counts have dropped by more than half over the past four decades [7].

Peter Schlegal, professor and chairman of urology at Weill Cornell Medicine in New York, and vice president of the American Society for Reproductive Medicine, says “Since this is the best study that’s ever been done, it is concerning that it suggests such a progressive and dramatic decrease in sperm counts over time.”

“Since we don’t know what could be causing it, it’s worrisome” [8].

Numerous studies also reveal that testosterone levels in men have declined substantially over the past decades [9-11]

Over the past decades, girls in Western countries have also been reaching puberty at younger and younger ages… [12]

There is evidence to suggest that earlier puberty, coupled with no children, doubles a woman’s risk of early menopause [13].

Is there a possibility that vaccines could somehow contribute to lower sperm counts, earlier puberty and menopause, not to mention the growing numbers of women suffering hormonal issues such as polycystic ovarian syndrome (PCOS), estrogen dominance etc?

Given that no vaccine on the market has been tested long-term for ability to damage or impair fertility, we are left to theorize about potentials and correlations. Certainly, there are a number of ingredients used in vaccines that are possible ‘red flags’.

Aluminium: Used as an adjuvant in numerous vaccines, such as Hepatitis B (first dose administered within hours of birth), and HPV vaccines (given to 11-13yo boys and girls), is a metalloestrogen. It belongs to a class of metals that are capable of binding to oestrogen receptors and mimicking the action of physiological oestrogen [14]. Mercury is also a metalloestrogen.

Glutaraldehyde: Classified as a reproductive toxin in females, and suspected reproductive toxin in males, capable of inducing DNA damage in mammals [15], is found in DTaP vaccines given to infants as young as 6 weeks.

Cetyltrimethylammonium bromide: A surfactant used in some influenza and typhoid vaccines.

No data available on its ability to cause cancer, birth defects or DNA damage, however, animal test data suggests it may cause adverse reproductive effects and birth defects. May also be toxic to the liver, cardiovascular and nervous systems [16].

2-Phenoxyethanol: According to the National Center for Biotechnology Information, 2-phenoxyethanol is the same as ethylene glycol, which has been shown to cause “wasting of the testicles, reproductive changes, infertility and changes to kidney function” [17].

Sodium borate, or Borax: Used in the Hepatitis A and HPV vaccines, and is added as a buffer, to “resist changes in pH, adjust tonicity and maintain osmolarity” [18].

Animal studies “show that the primary targets for borate toxicity are the developing fetus and the male reproductive system”. (Note that adolescent boys are now being targeted for HPV vaccination.)

Reproductive effects included atrophy of the testes and infertility [19].

Those are the ingredients we know about. What about vaccine contaminants, which scientists admit there is no possible way to screen for all potential contaminants [20-22], and even if there were, the FDA and other regulatory agencies only offer ‘guidance’ on how vaccine manufacturers ‘should’ screen vaccine lots [23]?

In 2003, three states in Northern Nigeria boycotted the oral polio vaccine, due to the alleged discovery of contaminants, including trace amounts of estrogen. The boycott lasted for 15 months [24].

In 2015, Catholic Bishops in Kenya announced that they had tested vials of the tetanus vaccine, then being used to vaccinate women of child-bearing age, and found them laced with beta-HCG, a pregnancy hormone [25]

The Catholic Church operates about 30% of health clinics in Kenya, and is not opposed to vaccination per se [26], but suspicions began to arise over the secrecy surrounding the WHO/UNICEF vaccination campaign (vials were delivered to health clinics under police guard, and empty vials returned to Nairobi, also under police guard), and the unusual policy of 5 doses of tetanus toxoid vaccine, administered every 6 months [27].

One of the laboratories used to test the vaccines for contaminants, Agriq-Quest, later had their license suspended by the Kenyan government. Agriq-Quest, however, claimed it was because they refused to doctor the samples to show the vaccines were clean [28].

As Oller et al (2017) noted: “…WHO biomedical researchers have been working to engineer such an “anti-fertility” vaccine for “birth-control” at least since 1972. Research published in 1976 confirmed that recipients of a vaccine containing βhCG chemically conjugated with TT (tetanus toxoid) develop antibodies not only against TT but also against βhCG. The result, first reported by WHO researchers at a meeting of the US National Academy of Sciences, is a “birth-control” vaccine that diminishes the βhCG essential to a successful pregnancy and causes at least temporary “infertility”. Subsequent research showed that repeated doses can extend infertility indefinitely” [29]

During the 1990’s, numerous reports surfaced that millions of women in Nicaragua, Mexico and Phillipines had been targeted by WHO ‘anti-fertility’ vaccination campaigns, under the guise of ‘eliminating neonatal tetanus’ [30].

More recently, In December, 2018, Italian research group, Corvelva, announced that they had received a donation from the Italian National Order of Biologists, and intended to test the contents of every vaccine currently on the market.

Their results so far have been disturbing. For instance, their testing of Hexyon 6-in-1 infant vaccine (recently approved for use in the US, beginning in 2020, under a different trade name) not only revealed a conspicuous absence of some antigens meant to be in there, they also noted the presence of many contaminants not meant to be in there [31]!

These included:

Diethylatrazine: Pesticide, second most widely used pesticide in the US (after glyphosate), but banned in Europe due to persistent groundwater contamination. It is suspected to be an endocrine disrupter and reproductive toxin. Studies found that the chemical caused male frogs to develop female characteristics, possibly because testosterone levels decreased by 10 times, when exposed to atrazine at just 25 ppb (parts per billion) [32]

Sulfluramid: Insecticide (which contains fluoride), not approved for use in EU. Was due to be phased out in US by 2016. Used in a variety of termite, ant and cockroach baits. Animal studies suggest that sulfluramid may adversely affect the reproductive system, especially in males, and/or cause infertility in males [33]

References:

[1] Little DT, Ward HR. premature ovarian failure 3 years after menarche in a 16-year-old girl following human papillomavirus vaccination, BMJ Case Reports, 2012, doi:10.1136/bcr-2012-006879.

[2] Wetzstein C. HPV Vaccine Cited in Infertility Case, The Washington Times, November 11, 2013.

[3] DeLong G, A lowered probability of pregnancy in females in the USA aged 25–29 who received a human papillomavirus vaccine injection, Journal of Toxicology and Environmental Health, Part A, 2018, 81(14): 661-674]

[4] Donahue JG, Kieke BA, King JP et al, Association of spontaneous abortion with receipt of inactivated vaccine containing H1N1pdm09 in 2010-11 and 2011-12, Vaccine, 2017, 35(40):5314-5322.

[5] Tietze C and Lewit S, Abortion, Scientific American, 1969, 220:21.

[6] Cheadle C, Dropping Fertility Rates are a Threat to the Global Economy, Business Insider, https://www.businessinsider.com/dropping-fertility-rates-will-affect-the-economy-2016-11?IR=T. Accessed March, 2019.

[7] Levine H, Jørgensen N, Martino-Andrade A, et al, Temporal trends in sperm count: a systematic review and meta-regression analysis, Human Reproduction Update, 2017, 23(6): 646–659.

[8] Stein R, Sperm counts plummet in western men, study finds, NPR, 31st July 2017, https://www.npr.org/2017/07/31/539517210/sperm-counts-plummet-in-western-men-study-finds. Accessed February, 2019.

[9] [Andersson AM, Jensen TK, Juul A et al, Secular Decline in Male Testosterone and Sex Hormone Binding Globulin Serum Levels in Danish Population Surveys, The Journal of Clinical Endocrinology & Metabolism, 2007, 92(12): 4696–4705.

[10] Travison TG, Araujo AB, Amy B. O’Donnell AB, et al, A Population-Level Decline in Serum Testosterone Levels in American Men, The Journal of Clinical Endocrinology & Metabolism, 2007, Volume 92(1): 196–202.

[11]Perheentupa A, Mäkinen J, Laatikainen T, et al Vierula, M., Skakkebaek, N., Andersson, A., & Toppari, J. A cohort effect on serum testosterone levels in Finnish men, European Journal of Endocrinology, 2013, 168(2): 227-233.

[12] Boaz NT, Essentials of biological anthropology, 1999, Prentice Hall, New Jersey.

[13] Thacker HL, Does early menstruation mean earlier menopause? https://speakingofwomenshealth.com/column/does-early-menstruation-mean-early-menopause. Accessed February 2019.

[14] Darbre P, Metalloestrogens: an emerging class of inorganic xenoestrogens with potential to add to the oestrogenic burden of the human breast, J Appl Toxicol, 2006, 26(3): 191-197.

[15] Science Lab. MSDS Glutaraldehyde, http://www.sciencelab.com/msds.php?msdsId=9924161. Accessed October, 2017.

[16] Science Lab. MSDS Cetyltrimethylammonium bromide, http://www.sciencelab.com/msds.php?msdsId=9923367. Accessed October, 2017.

[17] Santa Cruz Biotechnology Inc. MSDS: 2- phenoxyethanol, http://datasheets.scbt.com/sc-238193.pdf. Accessed October, 2017.

[18] The Immunization Advisory Centre. Vaccine Ingredients Factsheet for Parents and Caregivers, http://www.immune.org.nz/vaccines/vaccine-development/vaccine-components. Accessed October, 2017.

[19] U.S. Forest Service. Human Health and Ecological Risk Assessment for Borax Final Report, https://pdfs.semanticscholar.org/ac73/7b23b40f58669398317e30efe51833c361c5.pdf. Accessed October, 2017.

[20] Stang A, Petrasch- Parwez E, Brandt S, et al. Unintended spread of a biosafety level 2 recombinant retrovirus, Retrovirology, 2009, 6:86.

[21] Veerasami M, Chitra M, Mohana Subramanian B, et al. Individual and multiplex pCR assays for the detection of adventitious bovine and porcine viral genome contaminants in the commercial vaccines and animal derived raw materials, J Vet Sci Tech, 2014, 5:3.

[22] Marcus-Sekura C, Richardson JC, Harston RK, Sane N, Sheets RL. Evaluation of the Human Host Range of Bovine and Porcine Viruses that may Contaminate Bovine Serum and Porcine Trypsin Used in the Manufacture of Biological Products. Biologicals : Journal of the International Association of Biological Standardization. 2011;39(6):359-369.

[23] FDA. Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related product, https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm092272.pdf. Accessed March 2019]

[24] ABC News, Vaccine Boycott Grows in Northern Nigeria, 24th February, 2004.

[25] Kenya Conference of Catholic Bishops: Press Statement by the Kenya Conference of Catholic Bishops, http://www.kccb.or.ke/home/news-2/press-statement-by-the-kenya-conference-of-catholic-bishops/. Accessed March, 2019.

[26] Kenya Conference of Catholic Bishops: Catholic Health Commission of Kenya, http://www.kccb.or.ke/home/commission/12-catholic-health-commission-of-kenya/. Accessed March 2019.

[27] Oller, JW, Shaw CA, Tomljenovic, L., et al, HCG Found in WHO Tetanus Vaccine in Kenya Raises Concern in the Developing World. Open Access Library Journal, 2017, 4: e3937.

[28] Obara V, License of industrial lab Agriq-Quest suspended, Business Daily, 12th January, 2017, https://www.businessdailyafrica.com/Corporate-News/Licence-of-industrial-lab-Agriq-Quest-suspended/539550-3515280-j78flcz/. Accessed March, 2019.

[29] Oller, JW, Shaw CA, Tomljenovic, L., et al, HCG Found in WHO Tetanus Vaccine in Kenya Raises Concern in the Developing World. Open Access Library Journal, 2017, 4: e3937.

[30] Ibid

[31] Corvelva, Study on the chemical composition of Hexyon, Available at: https://drive.google.com/file/d/12e3O0cT1hSMGULzvFg3DcoM_XyGZMRur/view. Accessed 24th January, 2019.

[32] Hayes TB, Collins A, Lee M, Mendoza M, Noriega N, Stuart AA, Vonk A, Hermaphroditic, demasculinized frogs after exposure to the herbicide atrazine at low ecologically relevant doses, Proc Nat Acad Sci, 2002, 99(8): 5476-5480.

[33] US EPA memorandum, “Sulfluramid – Amount of A.I. in Raid Max Roach Bait.” To Mike Mendelsohn, PM Team Reviewer, Registration Division (7505C). From Linda L. Talor, Ph.D., Toxicology Branch II, Health Effects Division (7509C) and Marcia van Gemert, Ph.D., Chief, Toxicology Branch II/HED (7509C), August 10, 1994.].

The Truth About Vaccines & Other Drugs in Africa

There seems to be a perception in the Western world that African children are dying due to lack of vaccines, but is that actually true? Not exactly.

In many cases, the relentless push for vaccines (usually by outside interests) as a magic fix for disease, has come at the expense of other interventions.

According to UNICEF statistics, Rwanda has 95% – 98% vaccination coverage for diptheria-tetanus-pertussis…yet 37% of children are stunted due to malnutrition. Only 62% have access to proper sanitation [1]

Botswana has 95% children vaccinated with three doses of diptheria-tetanus-pertussis vaccine…but just over half receive Vitamin A supplementation (lauded in the early 1990’s as THE most effective health intervention of all), and only 20% of infants are exclusively breastfed [2].

Malawi is ranked 9th poorest country in the world, with more than half its people living below the poverty line, 9.6 million Malawians (more than half the population) don’t have access to a decent toilet, 5.6 million people (1 in 3) don’t have access to clean water, and 42% of children are stunted [3], yet more than 80% of children are up-to-date with vaccinations…[4].

The Malawi vaccination schedule now includes vaccines for measles, polio, cervical cancer, rotavirus, pneumococcal disease, diphtheria, tetanus, pertussis, hepatitis B, Haemophilus Influenza type B (Hib) [5].

According to UNICEF, almost 90 percent of child deaths from diarrhoeal diseases are directly linked to contaminated water, lack of sanitation, or inadequate hygiene [6], but money that may have been spent on sanitation and procurement of clean water, is spent on rotavirus vaccines instead.

Also, recall that the diptheria-tetanus-pertussis vaccine used in poor African countries is likely the old whole-cell thimerosal-containing vaccine, due to being cheaper than the new acellular vaccine [7].

African countries are increasingly rolling out HPV vaccination campaigns for school-girls. While it’s true that the majority of cervical cancer cases are in developing countries, one can’t help but wonder if HPV vaccination is a wise use of resources, given the more pressing needs in many sub-saharan countries.

In 2011, Merck donated 2 million doses of Gardasil vaccine to Rwanda, and 95% of the nation’s 11-year-old girls were vaccinated. The freebies ran out after three years, at which time Merck offered the vaccine to the Rwandan government at ‘discount prices’. Such donations can have the effect of locking governments into programmes which they later have to fund themselves, at the expense of more pressing issues, and may be more about ‘priming the market’, than charity on the part of the drug company [8-9].

Between 2013 – 2016, 26, 766 young girls in Malawi were given quadrivalent HPV vaccination as part of a pilot project, supported by GAVI – and 2051 girls who participated were under the age of 9 [10].

Vaccination coverage in Tanzania in 2014 for school and out of school girls was estimated at 93 per cent and 92.6 per cent, respectively. The chief Health Minister boasted that, despite “heartbreaking stories of the ill effects of vaccines” online, Tanzania had not even registered one single adverse reaction from the vaccine [11]. Is there an incentive for African governments – hopeful of foreign investment from pharmaceutical companies to downplay risks and reactions, in order to keep up the flow of income?

In December 2012, 500 children in Chad received a new experimental meningitis vaccine, and 38 children were later hospitalized, with 7 of the children flown to Tunisia for specialized treatment. The Chadian government declared their “state of health is not worrying”, but other sources in Chad claimed the children were paralysed [12-13].

In 2008, the Center for Research on Multinational Corporations reported (among others) the case of clinical trials in Uganda between 1997 – 2003, where thousands of women suffered adverse reactions to the drug Nevirapine, and some died – and all of it went unreported, while testing continued [14].  

Supplemental Immunization Activities

In addition to routine childhood vaccines, WHO and other agencies also conduct ‘supplemental immunization activities’, which are mass vaccination campaigns that aim to administer extra doses of vaccines. According to the WHO, there have been “thousands of these supplementary vaccination campaigns” with oral polio vaccine since the 1980’s, with children vaccinated regardless of prior vaccine history. The extra doses were not recorded on the child’s health cards [15].

Extra doses of measles vaccines are also given. A quick look at the Measles and Rubella Initiative Calendar for 2019 shows they plan on supplementally vaccinating more than 100 million people in sub-Saharan Africa this year – in addition to routine vaccinations [16].

Experimental Vaccines

In addition to routine vaccinations and supplementary vaccination, poor African countries are increasingly used to test experimental vaccines because it’s quicker and cheaper and less stringent regulations than western countries “Development cycles can be reduced thanks to the faster recruitment of subjects from a larger pool of patients. The costs of recruiting patients and paying investigators are lower too” [17]

This poses some real ethical problems. I have never been to Africa but I have lived in a developing country, and witnessed first-hand the reverence given to those who are in positions of power, or overseas-trained. People are too embarrassed or intimidated to ask questions of their doctor or report side-effects, as it would seem disrespectful and ‘out of line’ with the societal and cultural hierarchy.

Other developing regions face similar issues. M. Nabeel Ghayur, a pharmacologist who worked in drug development in Pakistan says: “People actually have blind trust in their doctor in South Asia. They have no idea what drug development is, they have no idea what clinical trials are.”

He said there was little red tape in those countries, and that people would rarely ask about drug side effects and legal issues” [18].

Starting next month (March, 2019), 750,000 babies in Kenya, Ghana and Malawi will be given a new experimental malaria vaccine. The vaccine Mosquirix will be given to children in four doses- at six, seven, nine and 24 months through an injection on the upper arm [19].

 The Star newspaper in Kenya reported: “Mosquirix, also called RTS,S, was first conceived in the 1980s and has undergone all clinical trials, returning less than optimal results.

The vaccine – made by GSK – is only effective in 30 to 50 per cent of patients, says the WHO.

Its effectiveness diminishes over time and it disappears fastest in children who are most exposed to malarial mosquito bites. However, because no defence against malaria is perfect, the vaccine is being considered in addition to the existing defences” [20].

GlaxoSmithKline and its backers, including Bill and Melinda Gates Foundation, had already spent $565 million on developing the drug, which brought back disappointing results in early testing, and did not meet the expected criteria for a malaria vaccine set out by a WHO-led consortium”, which requires a “protective efficacy of more than 50% against severe disease and death, and last longer than one year.” [21]

In 2017, the Global Task Force on Cholera Control launched a very ambitious set of goals, including 90% reduction in cholera deaths by 2030. Naturally, vaccines feature prominently, namely the oral cholera vaccine. A year later, the ‘largest vaccination drive in history’ took place, with over 2 million people vaccinated for cholera in Zambia, Uganda, Malawi, South Sudan and Nigeria [22].  

As of January 2019, more than 66,000 people in the Democratic Republic of Congo have been vaccinated with Merck’s V920, an experimental Ebola vaccine [23].

A Chinese-made genetically-engineered Ebola vaccine was given to 500 adults in Sierra Leone in 2015, as part of a Phase II trial. The Chinese FDA then approved the vaccine, without any Phase III trials [24].

In 2018, some 20,000 Malawian children were enrolled to receive an experimental typhoid conjugate vaccine [25].

Supplemental Drugs

In addition to routine vaccines, supplemental vaccines and experimental vaccines…many African children (and pregnant women) are also given supplemental drugs – malaria (sulfa) drugs, three times during the first year of life (starting from 10 weeks old), or several times per year during childhood – even if they have no infection [26]. During pregnancy, mothers are given the drugs at least three times during the 2nd and 3rd trimesters – again, even if they have no infection [27].

This is called “intermittent preventive therapy”, and it was promoted aggressively by the Bill and Melinda Gates Foundation, to the tune of at least $28 million dollars, with the establishment of the ‘IPTi Consortium’ [28].

in 2008, a technical advisory group at the World Health Organization (who coincidentally has received more than $2.4 billion in donations from the Bill and Melinda Gates Foundation, since 2000 [29], including a $1.2 million grant in 2006, with the express purpose of ensuring “that the IPTi consortium outcomes are collated, assessed by international experts, and result in a WHO policy recommendation” [30])  failed to recommend the program, due to concerns over safety and efficacy.

The protests from the Gates Foundation and their scientists were so loud and insistent, it prompted WHO malaria chief to write a memorandum (which was later leaked to newspapers) to WHO director, Margaret Chan, saying: “although it was less and less straightforward that the health agency should recommend IPTi, the agency’s objections were met with intense and aggressive opposition from Gates-backed scientists and the foundation…” [31]

Not to be deterred, the Gates Foundation then donated funds to have the Institute of Medicine conduct another review, chaired by a doctor whose work has received at least $50 million in funding from the Gates Foundation [32].

Predictably enough, the IOM review concluded that “an intervention with results of this magnitude is worthy of further investment as part of a public health strategy to decrease morbidity from malaria infections in infants“, although they noted that “time and resources did not allow independent audits of trial conduct, data management, or analysis” [33].

The WHO malaria chief who protested the excessive influence of the Gates Foundation, was later replaced…by a member of the Gates-founded IPTi Consortium (and now Vice-President of Johnson & Johnson pharmaceutical company [34]) and WHO then proceeded to recommend these sulphonamide drugs to infants ( given at the same time as routine vaccines for diptheria-tetanus-pertussis and measles), children and pregnant mothers, despite evidence of increasing drug-resistance in sub-Saharan Africa…

Prior to the IPTp and IPTi programs, pregnant women in malaria-endemic areas of Africa were given weekly doses of chloroquine, until drug resistance and compliance issues made it unfeasible to continue [35].

Other chemical exposures

The use of DDT to control mosquitos in malaria-endemic areas was endorsed by the World Health Organization in 2006, and its use has been increasing ever since. The chemical is sprayed inside homes and buildings – according to a report by the United Nations Environment Program, at least 3952 tonnes of DDT were sprayed in Africa and Asia in 2007 [36].

Agricultural spraying of DDT is common in Africa, especially in West Africa, where mosquitos have developed resistance to it [37].

The vast wealth of precious metals and natural resources in Africa have been both a blessing and curse to its people. Gold and other mining in Africa have produced countless mountains of toxic wastes that pollute the air, soil and water, most notably with uranium, arsenic and lead [38].

Another form of pollution experienced in poorer parts of the world, such as sub-Saharan Africa, is indoor air pollution from cooking over open fires, using wood, charcoal, kerosene or animal dung. The World Health Organization estimates that as many as 3.8 million people die prematurely every year, due to health conditions caused by indoor air pollution, the majority due to pneumonia [39].

References:

[1] UNICEF, Statistics: Rwanda https://data.unicef.org/country/rwa/. Accessed February, 2019

[2] UNICEF Statistics: Botswana, https://data.unicef.org/country/bwa/. Accessed February, 2019.

[3] WaterAid, Facts and Statistics: Malawi, https://www.wateraid.org/mw/facts-and-statistics. Accessed February, 2019.

[4] WHO, WHO and UNICEF Estimates of Vaccine Coverage, 2017 Revision, https://www.who.int/immunization/monitoring_surveillance/data/mwi.pdf, Accessed February, 2019.

[5] GAVI The Vaccine Alliance, Iceland pledges US $1 Million to Immunise Children in Malawi, https://www.gavi.org/library/news/statements/2019/iceland-pledges-usd1-million-to-immunise-children-in-malawi/, Accessed February, 2019.

[6] UNICEF, Press Release, Children Dying Daily Because of Unsafe Water Supplies and Poor Sanitation and Hygiene, New York: UNICEF, 2013.

[7] WHO, Biologicals: Pertussis, https://www.who.int/biologicals/vaccines/pertussis/en/. Accessed February, 2019.

[8] The Guardian, Drug donations are great, but should Big pharma be setting the agenda? https://www.theguardian.com/world/2013/apr/29/drug-company-donations-bigpharma. Accessed September, 2017.

[9] Editorial, Financing HPV vaccination in developing countries, The Lancet, 2011, 377(9777):1544.

[10] Msyamboza KP, et al, Implementation of a human papillomavirus vaccination demonstration project in Malawi: successes and challenges, BMC Public Health series, 2017, 17:599.

[11] AllAfrica, Tanzania: Cancer Vaccination Program Registers Success, https://allafrica.com/stories/201602152199.html, Accessed February, 2019.

[12] MedicalExpress, 38 children hospitalised after meningitis shot in Chad, https://medicalxpress.com/news/2013-01-children-hospitalised-meningitis-shot-chad.html#jCp. Accessed February, 2019][

[13] England C, Minimum of 40 children paralyzed after new meningitis vaccine, VacTruth, https://vactruth.com/2013/01/06/paralyzed-after-meningitis-vaccine/. Accessed February 2019

[14] Kelly S, Testing drugs on the developing world, The Atlantic, 27th February 2013, https://www.theatlantic.com/health/archive/2013/02/testing-drugs-on-the-developing-world/273329/. Accessed February, 2019.]

[15] Helleringer S et al, Supplementary polio immunization activities and prior use of routine immunization services in non-polio-endemic sub-Saharan Africa, Bulletin of the World Health Organization, 2012, https://www.who.int/bulletin/volumes/90/7/11-092494/en/. Accessed February, 2019.

[16] Measles and Rubella Initiative, SIA Schedule, https://measlesrubellainitiative.org/resources/sia-schedule/. Accessed February, 2019.

[17] Edwards M, R & D in Emerging Markets: A new approach for a new era, McKinsey & Company, 2010, https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/r-and-38d-in-emerging-markets-a-new-approach-for-a-new-era. Accessed February, 2019.

[18] Joelving F Many drugs for US kids tested in poor countries, Reuters, 23rd August 2010, https://www.reuters.com/article/us-drug-tests-idUSTRE67M1VO20100823. Accessed February, 2019.

[19] Kulkani P, Malaria Vaccine trials in Africa: Dark saga of outsourced clinical trials continues, Newsclick, March 2018, https://www.newsclick.in/malaria-vaccine-trials-africa-dark-saga-outsourced-clinical-trials-continues, Accessed February 2019.

[20] Muchangi J, Kenyan children to get first malaria vaccine in the world next month, The Star,14th February, 2019, https://www.the-star.co.ke/news/2019/02/14/kenyan-children-to-get-first-malaria-vaccine-in-the-world-next-month_c1894869. Accessed February, 2019.

[21] Kulkani P, Malaria vaccine trials in Africa: Dark saga of outsourced clinical trials continues, Newsclick, 17th March 2018, https://www.newsclick.in/malaria-vaccine-trials-africa-dark-saga-outsourced-clinical-trials-continues. Accessed February, 2019.

[22] UNICEF, Global Task Force on Cholera Control marks a year of progress toward ending cholera worldwide, https://www.unicef.org/press-releases/global-task-force-cholera-control-marks-year-progress-toward-ending-cholera. Accessed February, 2019.

[23] Ward Hackett D, Ebola vaccinations expanding in Central Africa, https://www.precisionvaccinations.com/v920-ebola-vaccine-now-deployed-drc-uganda-and-south-sudan. Accessed February, 2019.

[24] Liu A, China approves domestic Ebola vaccine developed from recent outbreak, FiercePharma, https://www.fiercepharma.com/vaccines/china-approves-self-developed-ebola-vaccine-from-2014-outbreak-virus-type. Accessed February, 2019.

[25] Gordon M, Trial kicks off in Malawi: First child vaccinated with typhoid conjugated vaccine in Africa, http://www.coalitionagainsttyphoid.org/trial-kicks-off-in-malawi-first-child-vaccinated-with-typhoid-conjugate-vaccine-in-africa/. Accessed February, 2019.

[26] WHO, Intermittent Preventive Treatment in Infants, https://www.who.int/malaria/areas/preventive_therapies/infants/en/?fbclid=IwAR1yumPwTyZEqBUzCIlPatU8pafeR9qUbNBYTA-vf8_38iyhvAumqK7xTlE. Accessed February, 2019.

[27] WHO, Intermittent Preventive Treatment during Pregnancy, https://www.who.int/malaria/areas/preventive_therapies/pregnancy/en/. Accessed February, 2019.

[28] Bill and Melinda Gates Foundation, New grants to accelerate malaria research and development, https://www.gatesfoundation.org/Media-Center/Press-Releases/2003/09/Grants-for-Malaria-Research. Accessed February 2019.

[29] Huet N & Paun C, Meet the world’s most powerful doctor: Bill Gates, Politico, 4th May 2017, https://www.politico.eu/article/bill-gates-who-most-powerful-doctor/?fbclid=IwAR1t3JJlmxNRTqcZpgvo4dPAFtrZw5vknQJRd_4gDPaU06emIgnLGUtMl6s. Accessed February, 2019.

[30] Bill and Melinda Gates Foundation, How We Work: Grant, WHO, https://www.gatesfoundation.org/How-We-Work/Quick-Links/Grants-Database/Grants/2006/10/OPP37476. Accessed February, 2019.

[31] McNeil DG, Gates Foundation’s Influence Criticized, New York Times, 16th February 2008, https://www.nytimes.com/2008/02/16/science/16malaria.html?fbclid=IwAR1otqtbJWZ8t4lO-XIVDRfQmasdDlTR5Iy6BkjoCh65fDhCECvTazjIkAI. Accessed February 2019.

[32] VCU School of Medicine, Myron Levin M’67: A pioneer of the modern discipline of vaccinology, https://wp.vcu.edu/somdiscoveries/2017/05/myron-levine-m67-a-pioneer-of-the-modern-discipline-of-vaccinology/. Accessed February, 2019.

[33] [IOM, Committee on the Perspectives on the Role of Intermittent Preventive Treatment for Malaria in Infants, 2008, available at: https://www.who.int/immunization/sage/10_IOM_report_on_IPTi.pdf. Accessed February 2019.

[34] UW Dept of Global Health, Robert Newman, https://globalhealth.washington.edu/faculty/robert-newman. Accessed February 2019.

[35] Heymann DL, Antenatal chloroquine chemoprophylaxis in Malawi: chloroquine resistance, compliance, protective efficacy and cost, Trans R Soc Trop Med Hyg,.1990;84(4):496-8.] [Kayentao K et al, Comparison of Intermittent Preventive Treatment with Chemoprophylaxis for the Prevention of Malaria during Pregnancy in Mali, The Journal of Infectious Diseases, 2005, 191(1):109–116.

 [36] Cone M, Should DDT be used to combat malaria? Scientific American, 4th May 2009, https://www.scientificamerican.com/article/ddt-use-to-combat-malaria/. Accessed February 2019.

[37] WorldWatch, Malaria, Mosquitos and DDT, http://www.worldwatch.org/node/517. Accessed February. 2019.

[38] AlJazeera, Toxic City: The cost of gold-mining in South Africa, https://www.aljazeera.com/programmes/specialseries/2019/01/toxic-city-cost-gold-mining-south-africa-190123160346656.html?ref=hvper.com. Accessed February 2019.

[39] WHO, Household air pollution and health, https://www.who.int/news-room/fact-sheets/detail/household-air-pollution-and-health. Accessed February, 2019.

5 Measles Facts Ignored by Mainstream Media

  1. Nobody knows how many people die globally from measles.

Global death statistics and statistics claiming to prove how many lives are saved by vaccinations are produced via computer modelling through the use of assumptions and mathematical algorithms. Two modelling systems are used: Lives Saved Tool (LiST) is used increasingly by donor organizations, and the WHO/IVB model used by the World Health Organization’s Department of Immunization, Vaccines and Biologicals.

Both have their shortfalls:

For example, WHO modelling assumes that all unvaccinated children will have a measles infection by their 20th birthday [1], and a proportion of those cases (ascertained by expert panel) would die from measles.

The LiST tool assumes that the ‘herd’ is protected when vaccination coverage reaches 90%, even though we know that outbreaks still occur in areas with 99% vaccination rate [2].

As an example of how these different modelling systems, with their inbuilt assumptions, can affect the numbers, researchers estimated measles deaths for the year 2000 via the two modelling systems. One model estimated 671,521 deaths, while the other model estimated 224,084 deaths – less than half [1].

2. Measles is notoriously hard to diagnose.

Once upon a time, anybody with a fever and a generalized rash may have been diagnosed with measles. In 1998, only a mere 14% of measles diagnoses turned out to be correct in Australia [3] (Even today, 1 in 10 of all medical diagnoses are incorrect, according to the Society to Improve Diagnosis in Medicine [4]).

Even with widespread use of laboratory screening to confirm or rule out measles, correct diagnoses are not guaranteed, for two reasons:

  • Diagnostic bias promoted by health authorities. For example, the CDC advice to health professionals is “To minimize the problem of false positive laboratory results, it is important to restrict case investigation and laboratory tests to patients most likely to have measles”. Those “most likely” to have measles, of course, are the unvaccinated and those who’ve recently travelled abroad. This, of course, serves to reinforce the current paradigm that vaccination ‘works’ and measles has been eliminated from the US, and the only reason outbreaks still occur is because of travellers and the unvaccinated [5].
  • Laboratory testing is not guaranteed to be correct. The specimen needs to be collected at just the right time, and stored under the right conditions. According to the World Health Organization, dengue fever, chikungunya and zika viruses can also present with fever and rash…and test positive for measles – due to “non-specific reactions or formation of immune complexes that can produce a false positive IgM result in measles or rubella IgM assays [6].”

3. Vitamin A saves lives…but apparently is not as profitable as vaccines.

It has been known for decades that supplementing with Vitamin A substantially reduces mortality rates from infectious diseases in developing countries. In the case of measles, Vitamin A supplementation can halve the mortality rate [7].

In the early 1990’s, control of Vitamin A deficiency in developing nations was declared a major international goal, and lauded as possibly the most cost effective of all health interventions [8-9]. This is because sufficient levels of Vitamin A not only benefit overall health and immunity, but also prevent blindness. Why is it then, that decades later, a country like Rwanda has a 98-99% vaccination rate, but only 3% rate of Vitamin A supplementation [10]?

In developing countries, Vitamin A may be administered intravenously in hospitalized measles cases, but oral Vitamin A supplementation is not promoted for home use (which would potentially avert the need for hospitalisation) [11].

4. How the measles virus was supposedly ‘isolated’

The measles component in today’s vaccine was developed in 1954, by scientist John Enders. In a paper published by The American Journal of Public Health, Enders described how he did it [12]:

First, his team obtained ‘throat washings and blood’ from an 11-yo boy with measles named David Edmonston. When he added it to a specimen of ‘post-natal cells’ (cervical cord? Infant foreskin?), these cells fell ill. He assumed this was caused by the measles virus.

He then added the mixture to a culture of HeLa cells – human cervical cancer cells that are so aggressive, and so prolific, they have managed to contaminate many cell lines all over the world. The fluid that ran out, he poured onto a second culture of cells, and then a third, and so on, until he could see under microscope ‘giant multinuclear cells’. He attributed this to measles virus, not to aggressive cervical cancer cells.

He then passaged the fluid through human kidney cells numerous times, followed by numerous passages through human amnion cells, each passage undoubtedly creating more stress and mutations for the cells. When he injected the resulting fluid into monkeys, some got a ‘mild illness’ that in ‘some aspects’ resembled measles. This was all the proof Enders needed, that he had isolated the viral culprit causing illness in kids.

Enders decided using monkeys was too expensive, so went with chicken embryos to save costs, and today’s vaccine is still prepared on chicken eggs [13].

5. Measles Used to Treat Cancer

In 1973, the British Medical Journal published a case study, describing remission of infantile Hodgkin’s disease after natural measles infection [14]. The 23-month-old child developed measles, before radiotherapy could be started, and the researchers noted, “much to our surprise, the large cervical mass vanished without further therapy”.

In fact, vaccine-strain measles is currently being investigated as a potential treatment for cancer, with early results deemed as “promising”, with open trials still being conducted [15]. Earlier research stated that attenuated live measles virus demonstrated “propensity to preferentially infect, propagate in, and destroy cancerous tissue” [16]. 

It was explained that the reason for using modified viruses was “concerns regarding the potential of wild-type-viruses to cause serious side effects, technical limitations in manufacturing viral lots of high purity for clinical use, as well as the overwhelming excitement and fervent support the, at the time, newly emerging chemotherapy approaches that slowed down research on alternative strategies [17]”.

(Note also that a laboratory-engineered virus strain can be patented, which makes it much more desirable for drug companies).

In 2014, CNN aired the story of a woman with incurable multiple myeloma, who had already endured every type of chemotherapy available for that kind of cancer, two stem cell transplants, yet relapsed time and time again [18].

Scientists from the Mayo Clinic injected the woman with a genetically-engineered measles virus. The woman than experienced a high fever of 105, and vomiting (but declared it was the ‘easiest treatment’ she’d done by far). She went into remission for nine months, and then a small growth had to be removed surgically.

But was it the ‘measles’ virus that affected the cancer, or was it the purgative and cleansing action of the fever and vomiting – self-correcting mechanisms of the human body that are now largely suppressed through modern medicine?

In 1890, a young surgeon at New York City’s Memorial Hospital became dismayed at the frequent failures of surgery to treat cancer. His name was William Coley. He began to dig through the records of the hospital, and was intrigued to find the case of an immigrant dockworker, who was admitted to the hospital with a malignant tumour on his neck. He was later discharged without any treatment…and without any further sign of tumour on his neck [19].

William Coley tracked the man down, and found him in good health. It turned out that while the man was in hospital awaiting surgery, he developed a severe case of erysipelas, a painful red inflammation on the skin, accompanied by high fevers. The sarcoma on his neck vanished.

Coley began to experiment on those with inoperable cancers, by injecting bacterial endotoxins to produce a high fever, with an estimated cure rate of 60% (far surpasses the success rate of today’s treatment for stage 4 cancers). Note that the treatment was only successful if fever and skin eruption could be induced.

His product, Coley’s Toxins, was used all over the United States and Europe, but in the post-war years, when science and medicine were enthralled by the promise of ‘cutting edge’ technology such as radiation and chemotherapy, ‘fever therapy’ fell out of favour, and in 1962, Coley’s Toxins were banned by the Food and Drug Administration.

Ironically, ‘immunotherapy’ to treat cancer is now regarded as the ‘hottest area of cancer research’ [20]. Perhaps, if we looked at why people’s immune system had become so dysregulated to start with…?

Other random findings:

While still on the subject of measles, it would appear the current MMR vaccine was approved without having been tested in clinical trials, but rather, based on studies of the individual components.

The vaccine insert for the current MMR II vaccine references numerous studies, but they are ALL for the individual components of the vaccine, not the MMR vaccine [21].

There is one (small) study mentioned that appears to have been based on the MMR II vaccine but…no references are provided.

Clinical trials are generally conducted in phases of ever-increasing numbers of participants. Phase 1 trials usually involve 20-100 healthy volunteers. Phase II usually involves 100-300 volunteers from the target market. And phase III usually involves 300-3000 volunteers from the target market. So, we’d expect to see more than just one study referenced for a new vaccine.

A visit to Merck’s website leaves us none the wiser. The same small study is promoted, but still, puzzlingly, no references are given for said study [22].


Since being approved, more and more adverse reactions have become apparent [23]:

Additionally, Merck stopped making the single vaccines in 2009, so if one wanted to be vaccinated for ‘measles’, they must have the triple-antigen vaccine [24].

References:

 [1] Chen WJ. Comparison of LiST measles mortality model and WHO/IVB measles model. BMC Public Health. 2011;11 Suppl 3(Suppl 3):S33. Published 2011 Apr 13. doi:10.1186/1471-2458-11-S3-S33.

[2] Boulianne N, De Serres G, Duval B, Joly JR, Meyer F, Déry P, Alary M, Le Hénaff D, Thériault N. Département de santé communautaire, Centre Hospitalier de l’Université Laval. [Major measles epidemic in the region of Quebec despite a 99% vaccine coverage] [Article in French]. Can J Public health. 1991 May-Jun;82(3):189-90].

[3] Francombe H. Measles diagnosis unreliable, Australian Doctor, Feb 18, 2000.].

[4] Society to Improve Diagnosis in Medicine. Reducing Harm From Diagnostic Error, http://www.improvediagnosis.org/. Accessed October, 2017

[5] Centers for Disease Control and prevention, Manual for Surveillance of Vaccine-preventable Diseases: Measles, https://www.cdc.gov/vaccines/pubs/surv-manual/chpt07-measles.html. Accessed February, 2019.

[6] WHO, Manual for the Laboratory-based Surveillance of Measles, Rubella, and Congenital Rubella Syndrome, https://www.who.int/immunization/monitoring_surveillance/burden/laboratory/manual_section4.2/en/. Accessed February, 2019.

[7] SOMMER A. Vitamin A prophylaxis, Archives of Disease in Childhood 1997;77:191-194.

[8] World Bank. World development report 1993: investing in health. Washington DC: World Bank/New York: Oxford University Press, 1993.

[9] National strategies for overcoming micronutrient malnutrition. 45th World Health Assembly (agenda item 21), 1992. World Health Organisation, Geneva.

[10] UNICEF, Statistics: Rwanda, https://www.unicef.org/infobycountry/rwanda_statistics.html#114. Accessed September, 2017.

[11] Mayo Clinic, Measles: https://www.mayoclinic.org/diseases-conditions/measles/diagnosis-treatment/drc-20374862. Accessed February, 2019.

[12] Enders J et al, Measles Virus: A Summary of Experiments Concerned with Isolation, Properties and Behavior, Am J Pub Health, 1957, 47(3):275-282.

[13] CDC, Prevention of Measles, Rubella, Congenital Rubella Syndrome, and Mumps, 2013 Summary Recommendations of the Advisory Committee on Immunization Practices (ACIP), MMRW, 2013, 62(4), pp 8.

[14] Mota C. Infantile Hodgkins’ disease: remission after measles. BMJ, 1973; 2(5863): 421.

[15] Aref S, Bailey K, Fielding A. Measles to the Rescue: A Review Of Oncolytic Measles Virus. Viruses, 2016; 8(10):294.

[16] Msaouel P, Dispenzieri A, Galanis E. Clinical testing of engineered oncolytic measles virus strains in the treatment of cancer: An overview. Curr Opin Mol Ther, 2009, 11(1): 43-53.

[17] ibid

[18] CNN, Measles virus used to put woman’s cancer into remission, https://edition.cnn.com/2014/05/15/health/measles-cancer-remission/index.html. Accessed February, 2019.

[19] Engelking C, Germ of an Idea: Coley’s Cancer-Killing Toxins, Discover Magazine, http://discovermagazine.com/2016/april/11-germ-of-an-idea. Accessed February, 2019

[20] Ibid

[21] FDA, MMR II vaccine, https://www.fda.gov/downloads/BiologicsBloodVaccines/UCM123789.pdf. Accessed February 2, 2019.

[22] MerckVaccines.com, Seroconversion Rates, https://www.merckvaccines.com/products/mmr/seroconversion-rates. Accessed February, 2019.

[23] FDA, Measles, Mumps and Rubella Virus Vaccine, Live, https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094050.htm. Acessed February 2, 2019.

[24] CDC, Q&A’s About Monovalent MMR vaccines, https://www.cdc.gov/vaccines/hcp/clinical-resources/mmr-faq-12-17-08.html. Accessed February 2, 2019.

How Vaccines Are Really Made

,
  1. First, collect the nasal or throat washing or urine of someone suspected of having the disease [1]. Or…if you were Jonas Salk or Albert Sabin, inventors of first polio vaccines, you collected the feces from people suspected of having polio, and then diluted it in water [2]. Refrigerate.
  2. Next, prepare a culture of monkey cells or mashed chicken embryos, by cutting them up, and adding chemicals to make them mutate and turn cancerous [3].
  3. Now, arrange these cells, single layer, into a lab vessel, and add a digestive enzyme from pig or cow pancreas’ called Trypsin. Take care to use gloves and splash goggles, because you do not want pure trypsin getting in your eyes…and careful not to add too much, or you’ll kill the cells outright [4].
  4. Next, add a nutrient broth and sugar to the by now stressed cells and allow them to marinate (recover) for a couple of days [3].
  5. Now take your original specimen of snot/phlegm/urine from the fridge, add to the monkey/chicken cells, and then place in a warm incubation chamber.
  6. After one hour, inspect the mixture with a microscope, and if 50% of the cells are now distorted, you’re on a winner! Scrape the cells into a medium, such as diluted blood of an unborn cow (fetal bovine serum [5]). Store at -70C and you now have a ‘pure isolate’ with which to make a vaccine!
  7. Next, you take cells that have a) descended from a baby that was aborted 60years ago, whose cells have been kept alive artificially, and replicating ever since [6], or b) cells that have descended from the kidneys of an African green monkey, and kept alive artificially, and replicating in a laboratory [7], or c) cells from a cocker-spaniel that were harvested in 1958, and have not only been kept alive and replicating ever since, but have been turned cancerous [8], and then infect these cells with your ‘pure virus isolate’. Give it some time, so all the cells can get ‘infected’ [9].
  8. Collect the fluid (cellular waste products) that runs out while the virus is ‘replicating’ in the incubation tanks, and pass it through a sieve and separator [10].
  9. Add some benzonase, which is a genetically engineered endonuclease produced in e.Coli, that attacks and degrades DNA and RNA [11].
  10. Next, add formaldehyde to ‘inactivate’ it.
  11. Now, time to filter and concentrate it, via ultracentifugion, which spins the fluid at super high speed to separate tiny particles from larger particles [10].
  12. Add some more benzonase to digest any leftover monkey/human DNA fragments that remain. This process is obviously not fool-proof, since DNA fragments are still found in the finished product
  13. Add some more chemicals to your ‘pure, concentrated product’:
  • Stabilisers, such as albumin from the blood of other humans, or produced by yeast cells that have had the gene for human albumin inserted into them.
  • Emulsifiers, such as Polysorbate 80, to stop the vaccine contents from separating.
  • Acidity regulators, such as borax (sodium borate), to maintain pH balance [12].

Your product is now ready to be added to vials, and distributed.

If you’re making an egg-based vaccine, such as the influenza vaccine, the process is slightly different. Instead of adding your ‘pure virus isolate’ to a cell culture, you inject it into fertilised eggs and let the chicken embryo ‘manufacture’ your virus for you. After about 72hrs, a machine sucks out the contents of the egg, which are then spun at super-high speeds and filtered. You can then carry on adding the chemical formulations to finish your product [13].

It takes approximately one egg to make one vaccine, so that equals around 500 million eggs used every year, to manufacture flu vaccines [14].

Egg-based vaccines take about 4 months to make one batch of vaccines [15], which is obviously time-consuming, and probably why manufacturers are looking for different methods of manufacturing…

The above descriptions may vary slightly depending on what virus or medium or manufacturing system you are using, but that is basically how the process works for viral vaccines. (For toxoid vaccines, such as tetanus and diptheria, the bacterium is encouraged to produce toxins, which are then ‘inactivated’ via centrifugion, or formalin treatment, and then adsorbed onto aluminium salt [16].)

Now, I know what you’re thinking. Surely, today’s modern vaccines are not so crudely made? You’re almost right! Although vaccine manufacturing facilities today are highly computerised and stainless steel, a number of vaccines are still made as described above. But newer vaccines, such as the Hepatitis and HPV vaccines are made somewhat differently.

They don’t use a virus, they take certain ‘key molecules’ said to come from the virus in question, and then insert them into an insect cell culture, or yeast culture to reproduce the desired quantities.

As you can imagine, a few ‘key molecules’ don’t create much of an immune reaction, which is why adjuvants, such as aluminium hydroxide are required [17].

The HPV vaccine has to be manufactured this way, because nobody has yet figured out a way to entice cell cultures to produce human papillomavirus (make of that what you will) [18].

Another new technology now being explored is DNA vaccines – using naked DNA particles said to come from the pathogen in question, which are then coated onto gold particles and shot directly into muscles via the use of a helium gas-pressurised gun, such as used in gene therapy [17].

Note that Points 1-6 are set out in ‘The Vaccine Papers’, by Janine Roberts, based on a CDC/WHO document titled ‘Isolation and Identification of Measles Virus in Culture’. That document was edited, and some things removed, after Roberts drew attention to it in radio interviews. The full script of the original document can be found in her book [1]. The amended version is still online here.

References:

  1. Roberts J. The Vaccine Papers, Impact Investigative Media Productions, Wigan UK, 2010.
  2. Sabin AB, Boulger L, History of Sabin Attenuated Poliovirus Oral Live Caccine Strains I J Biol Stand, 1973, 115, 115-118.
  3. NPTEL, Lecture 6: Isolation and purification of viruses and components, https://nptel.ac.in/courses/102103039/6. Accessed February 3, 2019.
  4. MSDS for Trypsin, https://www.lewisu.edu/academics/biology/pdf/trypsin.pdf. Accessed February 2, 2019].
  5. Humane Research Australia, Use of Fetal Calf Serum, http://www.humaneresearch.org.au/campaigns/fetal_calf_serum, Accessed February 2, 2019
  6. Fletcher, MA; Hessel, L; Plotkin, SA (1998). “Human diploid cell strains (HDCS) viral vaccines”. Developments in Biological Standardization. 93: 97–107.
  7. Ammerman NC, Beier-Sexton M, Azad AF. Growth and maintenance of Vero cell lines. Curr Protoc Microbiol. 2008;Appendix 4:Appendix 4E.
  8. Omeir RL, Teferedegne B, Foseh GS, et al. Heterogeneity of the tumorigenic phenotype expressed by Madin-Darby canine kidney cells. Comp Med. 2011;61(3):243-50.
  9. VxP Biologics, The Vero Vaccine Production Pipeline, https://www.vxpbiologics.com/the-vero-vaccine-production-pipeline/. Accessed February, 2019.
  10. Ibid
  11. Sigma Aldrich, Benzonase Nuclease, https://www.sigmaaldrich.com/catalog/product/sigma/e1014?lang=en&region=AU. Accessed February, 2019.
  12. Oxford Vaccine Group, Vaccine Ingredients, http://vk.ovg.ox.ac.uk/vaccine-ingredients#human serum albumin, Accessed January, 2019.
  13. The Telegraph, From chicken egg to syringe: How a flu vaccine is made, https://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/11138586/how-a-flu-vaccine-is-made-from-chicken-egg-to-syringe.html. Accessed February 3, 2019.
  14. Precision Vaccinations, 500 million easter eggs could be saved by the FDA, https://www.precisionvaccinations.com/chicken-eggs-produce-90-flu-vaccines. Accessed February 2, 2019.
  15. Singapore Government, Health Science Authority, Understanding Vaccines, Vaccine Development and Production, https://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Consumer_Information/Public_Advisories/Influenza_A_H1N1_information/H1N1_Vaccines/understanding-vaccines–vaccine-development-and-production.html. Accessed January, 2019.
  16. Plotkin S, Orenstein WA, Edwards K, Plotkin’s Vaccines, 7th Edition, 2018.
  17. Roberts J. The Vaccine Papers, Impact Investigative Media Productions, Wigan UK, 2010.
  18. Dixit R, Bhavsar C, Marfatia YS. Laboratory diagnosis of human papillomavirus virus infection in female genital tract. Indian J Sex Transm Dis AIDS. 2011;32(1):50-2.

Viagra (& Other Drugs) Found in Vaccine For Infants?

,

In December, 2018, Italian research group, Corvelva, announced they had received a donation from the Italian National Order of Biologists, and intended to test the contents of every vaccine currently on the market.

Their first results were shocking, but predictably overlooked by mainstream media. They found that Infanrix Hexa (6-in-1 vaccine currently used in Australia, UK, and other countries) didn’t even contain one antigen that was purported to be in the vaccine, but did contain chemical toxins and contaminants, many of which were unrecognisable [1].

Recently, more results were released, this time for Sanofi’s Hexacima/Hexyon – another 6-in-1 vaccine, currently licensed in Europe for infants from 6 weeks of age – and these results are just as disturbing…

Not only did they fail to find antigens for hepatitis B, Hib or poliovirus, they found over 200 chemicals and contaminants, of which 70% could not be identified in any chemical database [2].

Of those that were identified (to be verified via tandem mass spectrometry testing):

ANTU (alpha-Napthylthiurea): Rat poison, widely used in the 1940’s, but no longer licensed for use in the US, UK or European Union. Repeated exposure can injure the thyroid and adrenals, leading to hypothyroidism [3].

Benzofluorine: component of coal tar, cigarette smoke and smog, carcinogenic [4] [A component of some diuretic blood-pressure medications. Side effects may include dizziness, skin rashes (dermatitis), altered blood count, changes in metabolism [5].

Celecoxib: non-steroid anti-inflammatory drug (NSAID), Cox 2 inhibitor (inhibits the action of prostaglandins), similar to Vioxx. Side effects may include: fainting, kidney failure, bleeding, blurred vision, water retention, drowsiness, itchy rash. May increase risk of heart attacks and stroke [6].

Diethylatrazine: Pesticide, second most widely used pesticide in the US (after glyphosate), but banned in Europe due to persistent groundwater contamination. It is suspected to be an endocrine disrupter and reproductive toxin. Studies found that the chemical caused male frogs to develop female characteristics, possibly because testosterone levels decreased by 10 times, when exposed to atrazine at just 25 ppb (parts per billion) [7].

Gliotoxin: Major (and most potent) mycotoxin produced by aspergillus moulds [8].

Hydrocortisone Cypionate: Synthetic cortisone, possible side effects include: internal bleeding, increased white blood cell production, sleeplessness, Cushing’s Syndrome, osteoporosis, Lupus-like symptoms, seizures, heart failure [9].

Lovastatic Acid: The active, acid form of Lovastatin – a cholesterol-lowering ‘statin’ drug, whose side-effects may include jaundice, loss of appetite, unusual bleeding or bruising, hives, flu-like symptoms, abdominal pain [10].

Mibefradil: calcium-channel blocker, drug formerly used to treat hypertension, but withdrawn from the market in 1998 due to potential harmful interactions with other drugs: “Mibefradil reduces the activity of certain liver enzymes that are important in helping the body to eliminate many other drugs. Inhibiting these enzymes can cause some of these other drugs to accumulate in the body to dangerous levels [11].”

Pymetrozine: Insecticide, listed as ‘likely’ human carcinogen by EPA, due to tumors in animal studies [12].  

Sulfluramid: Insecticide (which contains fluoride), not approved for use in EU. Was due to be phased out in US by 2016. Used in a variety of termite, ant and cockroach baits. Animal studies suggest that sulfluramid may adversely affect the reproductive system, especially in males, and/or cause infertility in males [13].

Tamsulosin: Used by men to treat enlarged prostate. Class of drug known as alpha blocker – these are also used to lower blood pressure as they relax muscles (helping men with enlarged prostate to urinate more easily). Side effects may include low blood pressure and dizziness, pounding heartbeat, and possibly increased risk of heart failure [14].

Valnemulin: Veterinary antibiotic (antimicrobial) – when handling the product, veterinary assistants are advised to wear gloves, and avoid contact with skin or mucus membranes [15]

Viagra (Sildenafil): Although famously used to treat erectile dysfunction, Viagra was originally developed for high blood pressure and angina. Side effects may include: decreased blood flow to the optic nerve, resulting in sudden vision loss, heart attack, sudden hearing loss [16].

[1] [Corvelva, Vaccingate: Initial results on Infanrix hexa chemical composition, Available at: https://www.corvelva.it/speciali-corvelva/analisi/vaccingate-initial-results-on-infanrix-hexa-chemical-composition.html. Accessed 24th January, 2019.

[2] Corvelva, Study on the chemical composition of Hexyon, Available at: https://drive.google.com/file/d/12e3O0cT1hSMGULzvFg3DcoM_XyGZMRur/view. Accessed 24th January, 2019.

[3] Toxicology Data Network, Alpha-Napthylthiurea, https://toxnet.nlm.nih.gov/cgi-bin/sis/search/a?dbs+hsdb:@term+@DOCNO+1512. Accessed 25th January, 2019.

[4] Koganti A, Singh R, Rozett K, Modi N, Goldstein LS, Roy TA, Zhang FJ, Harvey RG, Weyand EH (2000). “7H-benzo[c]fluorene: a major DNA adduct-forming component of coal tar”. Carcinogenesis. 21 (8): 1601–1609.

[5] EMC, Bendroflumethiazide tablets, https://www.medicines.org.uk/emc/product/5726/pil. Accessed 24th January, 2019.

[6] RxList, Cox 2 Inhibitor Medications, https://www.rxlist.com/cox-2_inhibitors/drugs-condition.htm. Accessed 24th January, 2019.

[7] Hayes TB, Collins A, Lee M, Mendoza M, Noriega N, Stuart AA, Vonk A, Hermaphroditic, demasculinized frogs after exposure to the herbicide atrazine at low ecologically relevant doses, Proc Nat Acad Sci, 2002, 99(8): 5476-5480

[8] Kwon-Chung KJ, Sugui JA. What do we know about the role of gliotoxin in the pathobiology of Aspergillus fumigatus?. Med Mycol. 2008;47 Suppl 1(Suppl 1):S97-103.

[9] WebMD, Hydrocortisone Cypionate Suspension Side Effects by Likelihood and Severity, https://www.webmd.com/drugs/2/drug-8792/hydrocortisone-cypionate-oral/details/list-sideeffects. Accessed 25th January, 2019.

[10] Medline Plus, Lovastatin, https://medlineplus.gov/druginfo/meds/a688006.html. Accessed 25th January, 2019.

[11] Meinertz T, Mibefradil — a drug which may enhance the propensity for the development of abnormal QT prolongation, European Heart Journal Supplements, 2001, 3 (Supplement K), K89–K92.

[12] [US Environmental Protection Agency, Pymetrozine, https://www3.epa.gov/pesticides/chem_search/reg_actions/registration/fs_PC-101103_01-Aug-00.pdf. Accessed 25th January, 2019.

[13] US EPA memorandum, “Sulfluramid – Amount of A.I. in Raid Max Roach Bait.” To Mike Mendelsohn, PM Team Reviewer, Registration Division (7505C). From Linda L. Talor, Ph.D., Toxicology Branch II, Health Effects Division (7509C) and Marcia van Gemert, Ph.D., Chief, Toxicology Branch II/HED (7509C), August 10, 1994.

[14] Mayo Clinic, Alpha Blockers, https://www.mayoclinic.org/diseases-conditions/high-blood-pressure/in-depth/alpha-blockers/art-20044214. Accessed 25th January, 2019.

[15] European Medicines Agency, Annex 1, Summary of Product Characteristics, https://www.ema.europa.eu/documents/product-information/econor-epar-product-information_en.pdf. Accessed 25th January, 2019.

[16] Medical News Today, Uses and Risks of Viagra, Available at: https://www.medicalnewstoday.com/articles/232912.php. Accessed 24th January, 2019. �{�

How The Science Gets ‘Settled’

If you’ve heard it once, you’ve heard it a thousand times: The science is settled! If you disagree, you are branded ‘anti-science’ or ‘conspiracy theorist’.

You, too, might have the impression that the science on vaccines (or other drugs) is ‘settled’, and that’s not by accident. Here’s how the drug industry achieves that impression…

Clinical Trials

Almost 75% of U.S. clinical trials in medicine are now funded by the pharmaceutical industry [1].

Naturally, the industry has a huge financial stake in the outcome of these clinical trials – a phase III clinical trial may enrol 1000 – 5000 people over many years, and cost hundreds of millions of dollars to complete. Average cost per trial participant is around $36,000 [2]. That’s a lot of incentive to make it worth your while!

Analysis shows that trials funded by the industry are 5x more likely to recommend the experimental drug as treatment of choice, regardless of whether the results justify it, or not [3].

Clinical trials proceed in phases:

Phase I: Usually small numbers of healthy volunteers 20-100, to ascertain safety and dosage.

Phase II: Usually involves up to several hundred people with the disease/condition, or fits the user profile, to ascertain efficacy and side-effects.

Phase III: Involves several hundred to several thousand volunteers with the disease/condition, to monitor efficacy and adverse reactions.

There a number of ways clinical trials can be manipulated to give the results you want – or the appearance of the results you want…

First, you choose the people who are most likely to give the results you want. If you are looking at the safety of a vaccine, you enrol those who are least likely to have adverse reactions, and exclude those with a history of seizures, recent fevers or illness, or any blood clotting disorder [4]. (In the real world, these very people people are often urged to get the vaccine.)

Other methods used to increase the legitimacy of your product include [5]:

i) Seeding trials: Where a drug company induces a doctor to prescribe a certain drug to their patients, in order to gain feedback on the product. These are usually scientifically meaningless, have no clear end-points, but they are large-scale so represent considerable sales for the company. The doctor usually gets paid to enter patients in the trial.

ii) Switching trials: This is a variant of the seeding trial. Doctors are recruited to switch their patients from their usual treatment, to a new treatment. Again, the drug companies know that this will often lead to long-term customers.

iii) post-marketing surveillance: This is yet another variant of the seeding and switching trials, although with more scientific justification, as they are often published, and can provide important data on adverse effects. Again, doctors are paid substantial sums, and the patients may believe they are getting new and ‘better’ treatments.

iv) Dosage: The dose can be manipulated in order to give the desired results. For example, a competitor drug may be given at less-than-optimal dosage, to make the studied drug look more effective. Or the competitor drug may be given at higher-than-optimal dosages, to make the studied drug look safer.

v) Economic evaluations: These can be easy to manipulate, because they are too complex for the average journal editor or reader to fully understand.

Medical Journals

Now, when you get the favourable ‘results’, you have to let the world know all about it! A major randomised trial with favourable results, published in a prestigious journal, is a major win for a drug company, and an essential step in creating a ‘blockbuster’ drug [6-7].

A 2010 review of six major medical journals found that studies funded by industry are cited more often than those funded by other sources – more than twice as often in some journals [8].

So, if the industry-funded studies are more likely to recommend the drug in question (regardless of actual results), and then those same studies are used as a foundation for other research, being cited far more often than independent studies…can you see how the drug industry is able to build up an impression of their products being ‘rigorously tested’ and ‘highly effective’?

 The industry has figured out another way to keep their products in the editorial pages – it’s called ‘ghost-writing’. The drug company pays a writer to create an article containing ‘key marketing messages’, which is then sent to a doctor, who agrees to have his/her name attributed to the work in exchange for payment, before it is submitted to medical publications. Studies suggest that anywhere from 8% to 75% of journal articles may be ghost-written [9].

Clearly, this might appeal to some doctors who want the prestige of being a published author, quite apart from the financial incentive. The pharmaceutical company has final control over the paper, and if a doctor is not compliant enough, they simply get no further projects [10-11].

In many cases, if not all, the ghost-writer and the honorary author have not even viewed the raw data, they have merely been supplied with a summary from the sponsor company [12]. The honorary author is usually chosen because of their credentials, and their ability to influence other prescribers [13].

Of course, the desired effect of all this published data is threefold: a) it gives the appearance that the drug is thoroughly researched and widely accepted, b) which boosts doctor and patient confidence, c) while simultaneously providing an edge over rival products.

But…peer review!

At the heart of the scientific process is the concept known as peer review – where an author’s work is subjected to the scrutiny of other experts in the same field, before being published. The public perception is that the peer review process acts like a stop-gap that upholds the integrity of the scientific process, and filters out errors or fraud, but does it really?

The British Medical Journal decided to test for themselves how reliable the peer-review process is, by inserting major errors into papers before sending to reviewers. Some reviewers didn’t pick up any of the errors, while most picked up only about a quarter. Nobody picked up all the errors [14 -15].

So far, the evidence suggests that the peer review process is ‘slow, expensive, ineffective, something of a lottery, prone to bias and abuse, and hopeless at spotting errors and fraud [16] – but of course, the average internet troll doesn’t know that, yet!

The New England Journal of Medicine has long been ‘the journal to beat’ [17], yet two former editors-in-chief left their role in the top job, and went on to publish books exposing the excessive influence of the drug industry [18-19].

Meta-Analysis

A meta-analysis looks at data from multiple studies, and is used as part of systematic review. Naturally, these are useful and important in the interpretation of data.

A systematic review of vaccine meta-analyses, found that the methodological quality of all 121 meta-analyses included in the review (100%), were unsatisfactory. “The most frequent limitations include non-comprehensive bibliographic research; bias in the selection of the studies; lack of quality assessment of individual studies; absence of evaluation of heterogeneity among studies and publication bias” [20].

So, 100% of the vaccine meta-analysis cherry-picked the studies they wanted to include, in order for the ‘systematic review’ to show the results they wanted…These are the same meta-analyses that are used to guide government policies and legislation, WHO guidelines, doctors opinion…

The Role of Media

In order to further spread the good news of your product, you also need to make some news headlines, via press releases. The media are usually fairly compliant – they want a catchy headline, and…after all, drug companies do help to fund their jobs, via billions of dollars in advertising revenue [21].

A review of health news and current affair items on free-to-air TV in Sydney, Australia, estimated that up to 42% may have ‘been triggered by press releases and other forms of publicity [22].

Advertising and press releases are not the only way the pharmaceutical industry can influence the media. Another avenue is through a situation known as an interlocking directorate. This occurs when the director of one company sits on the board of directors of another company.

Many of the major news corporations have directors who also sit on director boards for pharmaceutical companies – and these cosy relationships have been shown to effect how health news is portrayed [23].

According to research, ‘the media can play an important role in influencing both the demand and supply of medical treatments, regardless of evidence of effectiveness [24].

Media coverage can increase uptake of the seasonal influenza vaccine, especially if reported in a headline, that includes words such as ‘vaccine shortage’ [25]. (Creates a sense of urgency.)

The so-called ‘swine flu pandemic’, which turned out to be more panic than pandemic, featured experts and academics making media appearances, promoting the use of retroviral drugs. It was later found that those who promoted retroviral drugs, were 8 times more likely to have links to industry – via research grants, honorarium payments, advisory roles, employment, board membership, speaker’s fees, etc – than those who did not comment on their use [26].

Getting Your Product Approved

Of course, all your journal articles and press releases are kind of pointless if you can’t get your drug through the regulatory process. In the US, UK, Australia and Canada, the regulatory agencies are all funded by industry (user-pays system), rather than by government [27-30].

Congressional investigations and reports have made damning conclusions on both the CDC and FDA: The Committee’s investigation has determined that conflict of interest rules employed by the FDA and CDC have been weak, enforcement has been lax, and committee members with substantial ties to the pharmaceutical companies have been given waivers to participate in committee meetings” [31].

If that’s not enough, you also have the ‘revolving door’ between government and industry – former employees now hired by drug companies to liaise with their former work-mates in the regulatory system. Studies suggest that more than half of former assessors at the FDA move on to positions within the pharmaceutical industry [32] – obviously their ‘inside knowledge’ is extremely valuable to the drug companies.

Occasionally, the door swings in the opposite direction – pharma employees moving into government jobs. The current secretary of the Department of Health and Human Services (HHS), Alex Azar was formerly a pharmaceutical lobbyist, and president of the US division of pharmaceutical giant Eli Lilly and Co [33]. In case you are not American, like myself, the HHS department guides the nation’s healthcare programs and policies, so…fairly influential.

Regulatory agents are not only funded by industry, as we have already noted, but they also rely on industry to conduct the trials, provide the safety data, and notify them of any issues that may arise post-licensure. The agencies themselves do not conduct clinical trials [34-37].

The Fate of Failed Clinical Trials

Now, what happens if, despite your best efforts, the clinical trials still didn’t give the results you wanted? You can still salvage your reputation by:

a) Just cut the trial short – to save money [38-40], or

b) Simply decide not to publish unfavourable trial results, even though doing so is considered to be scientific malpractice [41-42].

Research shows that less than half of government-funded clinical trial results are published in peer-reviewed medical journals within 30 months of trial completion [43].

One pharmaceutical company managed to suppress trial results for seven years, when they revealed that the drug in question was no more effective than cheaper generic formulations [44].

That, my friends, is a tiny glimpse into how science gets ‘settled’.

Any questions?

References

[1] Bodenheimer, T. 2000. Uneasy alliance: Clinical investigators and the pharmaceutical industry. New England Journal of Medicine 342:1539-1544.

[2] pHRma: Biopharmaceutical industry-sponsored clinical trials: impact on state economies, http://phrma-docs.phrma.org/sites/default/files/pdf/biopharmaceutical-industry-sponsored-clinical-trials-impact-on-state-economies.pdf. Accessed September, 2017.

[3] Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of Funding and Conclusions in Randomized Drug Trials A Reflection of Treatment Effect or Adverse Events?. JAMA. 2003;290(7):921–928.

[4] US National Library of Medicine: ClinicalTrials.gov. Hepatitis A vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study, https://www.clinicaltrials.gov/ct2/show/NCT00326183?term=vaccine&recrs=e&cond=varicella&age=0&phase=3&fund=2&rank=4. Accessed October, 2017.

[5] Smith R. Medical journals and pharmaceutical companies: uneasy bedfellows. BMJ : British Medical Journal. 2003;326(7400):1202-1205.

[6] Guyatt GH, Naylor D, Richardson WS, et al. What is the best evidence for making clinical decisions? JAMA. 2000 Dec 27; 284(24):3127-8.

[7] Smith R. Medical journals are an extension of the marketing arm of pharmaceutical companies. PLoS Med. 2005 May; 2(5):e138.

[8] Lundh A, Barbateskovic M, Hrobjartsson A, Gotzche pC. Conflicts of interest at medical journals: The influence of industry-supported randomised trials on journal impact factors and revenue-cohort study, pLOS One, 2010, 7(10): e1000354.

[9] Hill M. Ghosts in the Medical Machine, Philadelphia Inquirer, 20th September 2009.

[10] Petersen M. Madison Ave. Plays Growing Role in Drug Research. New York Times. 2002 November 22. Available at: www.nytimes.com/2002/11/22/business/22DRUG.html?pagewanted=5, Accessed January, 2019.] [Ngai S, Gold J. L, Gill

[11] Rochon P.A. Haunted Manuscripts: Ghost Authorship in the Medical Literature. Accountability in Research. 2005;12:p103–114.

[12] McHenry L. Of Sophists and Spin-Doctors: Industry-Sponsored Ghostwriting and the Crisis of Academic Medicine. Mens Sana Monographs. 2010;8(1):129-145.]

[13] Ibid.

[14] Godlee F, Gale CR, Martyn CN. Effect on the quality of peer review of blinding reviewers and asking them to sign their reports: a randomized controlled trial. JAMA. 1998 Jul 15; 280(3):237-40.

[15] Schroter S, Black N, Evans S, et al.Effects of training on quality of peer review: randomised controlled trial.BMJ. 2004 Mar 20; 328(7441):673.

[16] Smith R. The trouble with medical journals. Journal of the Royal Society of Medicine. 2006;99(3):115-119.

[17] Smith R. Lapses at the New England Journal of Medicine. Journal of the Royal Society of Medicine. 2006;99(8):380-382.

[18] Angell M. The Truth About Drug Companies: How They Deceive Us and What To Do About It. New York: Random House, 2005.

[19] Kassirer JP. On The Take: How Medicine’s Complicity With Big Business Can Endanger Your Health. New York: Oxford University Press, 2004.

[20] De Vito C, Manzoli L, Marzuillo C, et al. A systematic review evaluating the potential for bias and the methodological quality of meta-analyses in vaccinology, Vaccine, 2007, 25(52):8794-806.

[21] CBS News, Drug Ads: $5.2 billion annually – and rising, https://www.cbsnews.com/news/drug-ads-5-2-billion-annually-and-rising/. Accessed September, 2017.

[22] Chapman S, Holding SJ, Ellerm J, et al. The content and structure of Australian television reportage on health and medicine, 2005–2009: Parameters to guide health workers. Med J Aust, 2009, 191(11) 620–624.].

[23] Fairness and Accuracy in Reporting: Single-payer and interlocking directorates, The corporate ties between insurers and media companies, http://fair.org/extra/single-payer-and-interlocking-directorates/. Accessed February, 2017.

[24] Benelli E (2003) The role of media in steering public opinion on healthcare issues. Health Policy 63: 179–186.

[25] Yoo B-K, Holland ML, Bhattacharya J, Phelps CE, Szilagyi PG. Effects of Mass Media Coverage on Timing and Annual Receipt of Influenza Vaccination among Medicare Elderly. Health Services Research. 2010;45(5 Pt 1):1287-1309.

[26] Wise Jacqui. Academics who spoke out on swine flu risks were more likely to have industry links, study finds BMJ, 2013; 347 :f6758.

[27] Frontline. How independent is the FDA? http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/independent.html. Accessed October, 2017.

[28] House of Commons Health Committee. The Influence of the pharmaceutical industry: Fourth Report of Session 2004-2005.Published on 5 April 2005 by authority of the House of Commons London: The Stationery Office Limited.

[29] Government of Canada. Funding and Fees, https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees.html. Accessed October, 2017.

[30] Productivity Commission. Submission To The Productivity Commission, re: Federal Government Cost Recovery, https://www.pc.gov.au/inquiries/completed/cost-recovery/submissions/medical_industry_association_of_australia_/sub012.pdf. Accessed October, 2017.

[31] FACA: Conflicts of Interest and Vaccine Development: Preserving the Integrity of the Process, Before the Government Reform Committee of the House of Representatives, 106th Congress, June 15, 2000.

[32] Bien, J., & Prasad, V. (2016). Future jobs of FDA’s haematology-oncology reviewers. BMJ (Online), 354, i5055.

[33] Brennan Z. Revolving Door Between Industry and FDA Continues to Spin, Regulatory Affairs Professionals Society, 6th September, 2018.

[34] US Food and Drug Administration. Clinical Trials: What patients need to know, https://www.fda.gov/forpatients/clinicaltrials/. Accessed October, 2017.

[35] Medicines and Healthcare products Regulatory Agency. Medicines and Medical Devices Regulation: What you need to know, http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con2031677.pdf. Accessed October, 2017.

[36] Government of Canada. Clinical trials and drug safety, https://www.canada.ca/en/health-canada/services/healthy-living/your-health/medical-information/clinical-trials-drug-safety.html. Accessed October, 2017.

[37] Therapeutic Goods Administration. TGA regulatory framework, https://www.tga.gov.au/tga-regulatory-framework. Accessed October, 2017.

[38] Psaty BM, Rennie D. Stopping medical research to save money. A broken pact with researchers and patients.  JAMA2003;289:2128-2131.

[39] Canadian Association of University Teachers: The Olivieri Report, https://www.caut.ca/docs/af-reports-indepedent-committees-of-inquiry/the-olivieri-report.pdf?sfvrsn=0. Accessed September, 2017.

[40] Lievre M, Menard J, Bruckert E.  et al.  Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility.  BMJ.2001;322:603-605.

[41] Bodenheimer, T. 2000. Uneasy alliance: Clinical investigators and the pharmaceutical industry. New England Journal of Medicine 342:1539-1544.

[42] Chalmers I. Underreporting research is scientific misconduct.  JAMA.1990;263:1405-1408.

[43] Ross Joseph S, Tse Tony, Zarin Deborah A, Xu Hui, Zhou Lei, Krumholz Harlan M et al. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis BMJ 2012; 344 :d7292.

[44] Vogel G. Long-suppressed study finally sees light of day.  Science.1997;276:525-526. p