Mary Tocco, Is She Mistaken or Misrepresenting?

Something that has been noted here and elsewhere over the years is that anti-vaccine activists generally play rather loose and free with facts. They have this tendency to misrepresent reality in a way that suggests support for their opinions, and sometimes they even downright fabricate "facts" that have no basis in the real world. Take the long-debunked claim that vaccines contain anti-freeze. (They don't.) Because their goal is to stir up fears about vaccines, they latch onto scary-sounding chemical names and equate them with all manner of ills. Where nuance is called for, they resort to hyperbole. Their goal is fear, not truth.

Mary Tocco is no exception. I came across an article she wrote August 2 entitled "Seasonal Flu Vaccines, Are They Safe or Necessary?". Other than the poor word choice (I think they are generally safe and necessary in order to protect the greatest portion of the population; are they really only safe or only necessary?), I'll give you one guess as to what she thinks. In true anti-vaccine activist form, she jumps straight into getting things wrong in the very first paragraph:

The seasonal flu vaccine is now recommended every year for every man, woman and child from the age of 2 throughout the rest of life. This mandate is the result of the exaggerated H1N1 Flu pandemic of 2009 that proved to not even be a pandemic. This is a political vaccine with no scientific basis that will make millions for the flu manufactures and cause health problems for thousands. How does a person sift between the conflicting information provided? As a 30+ year independent vaccine researcher, I hope these facts will help you decide if you or your children will receive the seasonal flu vaccine.

First off, the vaccine is not mandated. It is a recommended vaccine. It is an optional vaccine. There is no requirement (i.e., mandate) that everyone age 2 and up receive it. Second, it was recommended before the 2009 H1N1 pandemic. The annual flu vaccine was first recommended for high-risk patients starting in 2002. In 2004, the recommendation was expanded to include healthy children aged 6-23 months. In 2007 it expanded to 6-59 months. The 2009 schedule (published well before the emergence of H1N1 in the U.S.) expanded it to include all children 6 months to 18 years. During that whole period, the flu vaccine was also recommended for healthy individuals who were in close contact with any of the other recommended populations (high-risk or children). The recommendation was clearly not the result of the H1N1 pandemic. And yes, it was a real pandemic. You see, here's the definition that the World Health Organization uses:

Phase 5 is characterized by human-to-human spread of the virus into at least two countries in one WHO region. While most countries will not be affected at this stage, the declaration of Phase 5 is a strong signal that a pandemic is imminent and that the time to finalize the organization, communication, and implementation of the planned mitigation measures is short.

Phase 6, the pandemic phase, is characterized by community level outbreaks in at least one other country in a different WHO region in addition to the criteria defined in Phase 5. Designation of this phase will indicate that a global pandemic is under way.

The H1N1 virus was spread widely among humans in many different countries across several different WHO regions.

As we constantly need to remind people like Ms. Tocco, before the virus really got going in the U.S., we really did not have a very good idea of what it was going to be like. It was a novel strain with little history. We did not know whether it would be mild, comparable to the seasonal flu or deadly. We did know that it was uncharacteristic, coming out of the blue and completely off-season. We also knew that it shared some similarities with the 1918 flu that killed millions, so there was definitely reason to be concerned. Because of the unknowns, we prepared for the worst, a "better safe than sorry" approach. Had the government not done so, and the 2009 H1N1 flu been deadly, there would have been a hue and cry, "Why didn't they act sooner?!" As it happened, this novel strain turned out to be relatively mild compared to expectations, though it did kill quite a number of people (275 pediatric deaths during the regular flu season).

Tocco then goes on to refer to the Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system set up to capture reports of adverse events following vaccination. She either doesn't understand what VAERS does, or purposefully misconstrues VAERS to scare her readers. VAERS is okay for finding trends for further study, but it cannot be used to show an actual causal relationship between a vaccine and an event. After all, one person even reported that a vaccine turned him into the Hulk.

Ms. Tocco also claims that the 2009 H1N1 vaccine was rushed to market. Well, yes and no. It was rushed in the sense that there was a potential health catastrophe looming, so the vaccine needed to get out quickly and was approved for expedited review. But it was not really rushed in the sense of cutting corners or not getting approval. Basically what the manufacturers did was take an existing, approved vaccine (seasonal flu vaccine) and use a different influenza serotype. They didn't need to come up with and test a brand spankin' new vaccine; they just needed to do some minor tests to ensure nothing was tragically and horribly different. They didn't need to take the time to calculate which serotypes were going to be the problem, since they already knew it was H1N1. All they needed to do was grow the virus like they normally do every year for the seasonal flu vaccine.

Next, we're treated to some very scary-sounding numbers:

According to the CDC Vital Statistics Report 1999-2003, Influenza death for children under the age of 5 skyrocketed as they began to implement the flu vaccine for the children. From 1999 to early 2002, death rates were declining from 25 down to 10 per year then the latter half of 2002 the CDC mandated the flu vaccine for children and the death rate climbed from 25 deaths per year in 1999 to over 90 in 2002!

And of course, Tocco claims that this is a side effect of the vaccine. What she fails to provide, however, is context or any evidence of any causal connection. For instance, how many children actually received the flu vaccine? Why did she pick 1999 as the starting point and 2002 as the end point? What happens if we take a look at the raw numbers for each year?

For children under 5 years of age from the earliest Vital Statistics Report available to the most recent final data, the total number of deaths, with all ages in parentheses, from influenza are (links are PDFs, prior years did not break out by age):

1997: 22 (720 overall)
1998: 9 (1,724 overall)
1999: 25 (1,665 overall)
2000: 19 (1,613 overall)
2001: 13 (257 overall)
2002: 12 (727 overall)
2003: 90 (1,792 overall)
2004: 36 (1,000 overall)
2005: 38 (1,812 overall)
2006: 37 (849 overall)
2007: 32 (411 overall)

So, we see some wobbling of the total numbers. 2003 looks to be an odd year out as far as pediatric deaths go, but as CDC reports and the overall numbers suggest, that was an influenza outbreak year, with a greater total number of infections.

Compare this with the list of years and deaths attributable to influenza that Tocco provides. Note that she does not provide links to her source, but simply lists it as "CDC Vital Statistics Report 1999-2003, Neil Miller Reported." By the way, it turns out that Neil Miller happens to write for whale.to, so it is little wonder that Ms. Tocco gets her facts stupendously wrong.

1999 — 29 deaths
2000 — 19 deaths
2001 — 13 deaths
2002 — 12 deaths
2003 — 90 deaths (Year of mass vaccinations of children under age 5 years)
2006 — 78 deaths
2007 — 88 deaths
2008 — 116 deaths (40.9% vaccinated at age 6 months to 23 months)

Perhaps Ms. Tocco should have gone directly to the source, the CDC, for her numbers, rather than taking the word of someone who is unabashedly anti-vaccine and who writes for a site that is well known to be reality-challenged. Of course, all of this ignores the fact that influenza is not a reportable disease, so the numbers reported above may not be accurate. Some years, surveillance may be lax, so an individual may not be tested for influenza prior to death, thus resulting in lower reported deaths due to the virus. In other years, health care providers and other public health officials may be more vigilant, meaning more tests and more reports of infection, thus, higher numbers of deaths reported as due to influenza. Then there is the matter of case definitions. Were all of these reported deaths confirmed by labs as actually being influenza and not a similar illness? Were there other deaths caused by influenza but attributed to something else?

The other thing to note is that Ms. Tocco cites flu deaths and states, based on some unknown evidence that she apparently wishes to keep secret, that those deaths were not due to natural infection, but rather were caused by the flu vaccine. Despite my best attempts, I was unable to find any citation for this claim in her article.

Let's take a look, too, at when the various flu vaccines were approved:

• FluMist - Approved June 17, 2003 for 5-49 year olds. Age range expanded to 2-49 on Sept. 19, 2007. Since this was not approved for under 5 years old until 2007, it likely plays no role in Ms. Tocco's proposed flu vaccine calamity.
• AFLURIA - Approved September 28, 2007. The 2009 H1N1 formulation approved for 6 months - 17 years on November 10, 2009. Again, this was approved long after the "horror" year of 2003.
• Agriflu - Approved November 27, 2009 for 18 years and older. It has not been approved for marketing for children under 18 years.
• Flulaval - Approved for adults 18 years and older on October 5, 2006. It has not yet been approved for use in anyone younger than 18 years of age.
• Fluarix - Approved August 31, 2005 for adults 18 years and older. Approved for children 3 years and older on October 19, 2009.
• Fluvirin - Approved in 1988 (PDF). Approved for ages 4 years and up.
• Fluzone - Approved in 1980. Approved for ages 6 months and up.

There are only two vaccines that were in pediatric use prior to the supposed jump in flu-related deaths: Fluvirin and Fluzone. Those had been in use for a significant amount of time prior to the increase in flu deaths. We should have seen at least some increases before 2003 if vaccines are implicated, since they were in use, even if not on the recommended schedule, for quite some time.

Did I mention how Tocco abuses VAERS data to scare readers? After talking about all those deaths, for which she provided no evidence connecting them to vaccines, she goes on to cite VAERS reports of miscarriages following vaccination of pregnant women. Apparently, Ms. Tocco did not, as directed, read and understand the caveats about VAERS data, particularly the bit about how the database includes coincidental events. That is, there are things that, by chance, occurred shortly after administration of a vaccine, but which have no cause-effect connection to the vaccine. At any rate, Tocco cites a report from the National Coalition of Organized Women (NCOW) that supposedly found a lot of miscarriages following influenza vaccination. The only problem is that the report is based on a study that was, to put it mildly, flawed. For more on the lack of science in the study, see what Dr. Steven Novella has to say.

Ms. Tocco also cites flu vaccine inserts that state that no studies have been done to determine the effects in pregnant women. What she fails to say, and perhaps does not understand, is that the package insert is limited to what the manufacturer has done. Inserts are partially marketing materials, and they may make no claims in it for which they have not done studies and received approval from the FDA. Similarly, adverse events listed are what they have gathered either from studies (i.e., established a likely causal connection) or from post-market reporting (i.e., connection may be causal or coincidental); in essence, it is a way for them to cover their butts if an adverse reaction occurs. All that is to say that while manufacturers may not have studied the effects of flu vaccines in pregnant women, others have. Do a search on pubmed.gov for "influenza vaccine pregnancy" and you will pull up hundreds of studies, including this one from 1981 that found no adverse effects on physical or neurological development of infants at birth or 8 weeks of age when the pregnant mother had received a flu vaccine. There is also this document (PDF) from 1984, which states that there has been no evidence that inactivated influenza virus causes adverse effects in pregnant women or their babies. The studies span the years all the way up to the present. You'll also find in that list what can happen if a pregnant woman is infected with the flu.

And what anti-vaccine diatribe would be complete without the "toxin gambit"? Tocco does not disappoint, as she includes a list of vaccine ingredients, which, by the way, is not even accurate. Of course she lists things like formaldehyde (a substance that is produced by the body and used for amino acid synthesis) and human diploid tissues, which she described as "organ and tissue from aborted baby tissue is now used in manufacturing many vaccines." She doesn't mention that Afluria, Fluvirin and FluMist contain no formaldehyde, and there are two things wrong with her statement about diploid tissues: 1) no vaccine contains aborted fetal tissue - they use cell lines that were grown in the lab over decades; 2) influenza vaccines do not use any human diploid cells. Similarly, she lists squalene, a naturally occurring oil that can be found in things like shark liver oil supplements. What she states correctly is that squalene is not approved for use in the U.S. What she fails to also state is that not a single U.S. vaccine uses squalene (which, for those interested in such things, has actually been used in Europe for over 10 years with a decent safety profile).

I will leave the rest of her article to my readers; there is plenty of material there to correct. For someone who describes herself as "a 30+ year independent vaccine researcher," Mary Tocco shows a significant lack of understanding of even basic facts. I am left with the following conclusion: Ms. Tocco is either an incompetent researcher, a grossly mistaken researcher or a researcher who lies to advance her agenda. This is, of course, my opinion based upon one article on her site that is riddled with fear- and conspiracy-mongering books that you can acquire in exchange for monetary compensations to Ms. Tocco or other authors. As always, I am open to changing my opinion and correcting my article should compelling evidence warrant, but for now, I feel my assessment of Ms. Tocco is reasonably accurate.