August 06, 2014

Invitation to Open Debate On Thimerosal


This week I am publishing, in book form, the world’s first comprehensive review of the scientific literature, relevant to the issue of whether thimerosal, a mercury-based vaccine preservative, is safe to inject into humans. I assembled this book, Thimerosal: Let the Science Speak with the help of Dr. Mark Hyman, New York Times best-selling author of The Blood Sugar Solution and medical director of the UltraWellness Center and public health expert, Dr. Martha Herbert, assistant professor of neurology at Harvard Medical School and pediatric neuroscientist at the Massachusetts General Hospital. We mobilized a crack team of nearly a dozen independent scientists, writers and researchers who spent close to three years scouring the medical literature to gather and digest nearly every published peer-reviewed article on thimerosal safety.[1] They managed to collect hundreds of relevant articles yet were unable to find even a single publication credibly demonstrating thimerosal’s safety. A preponderance of toxicological, pharmacological, epidemiological, animal and human studies implicate thimerosal as a threat to human health. In fact, we feel there is a strong consensus among the many research scientists who have published peer-reviewed articles in the field on thimerosal that the chemical should not be injected into children.

Thimerosal is about half ethylmercury by weight. There is debate about the degree of toxicity of ethylmercury compared to the much-better-studied methylmercury, which all agree is a potent neurotoxin, and for which the Food and Drug Administration and the Environmental Protection Agency have exposure guidelines. But that debate is similar to quarreling over whether uranium is less toxic than plutonium. They are both toxic. The U.S. Governement’s Institute of Medicine performed a comparative analysis and concluded, “Ethylmercury should be considered equipotent to methylmercury as a developmental neurotoxin.” Exposure to both should therefore be minimized. Nevertheless, today, we continue to expose millions of babies and pregnant women in this country and elsewhere to ethylmercury via thimerosal, meanwhile attempting to shield them from its close cousin, methylmercury.

We first circulated the book to government regulators, leading scientists and policy makers, beginning in August 2013. We then sat on the book for almost a year while the HHS (Health and Human Services) and the agency’s National Vaccine Program Office, along with the FDA and the CDC (Centers for Disease Control and Prevention), considered the book’s contents. We met, spoke and corresponded with these agencies frequently. It was our hope that government officials would take seriously the science that demonstrates thimerosal’s neurotoxicity. We hoped they would quietly remove thimerosal from the remaining vaccines and other medical products it is in, or replace thimerosal with proven, safer alternatives, such as the preservative 2-phenoxyethanol (2-PE), presently used in an inactivated polio vaccine.

We were reluctant to release the book, fearing that it might scare people and reduce vaccine coverage. The regulators have now made it clear they will not act, so we are left with no option but to publish in the hope that a healthy public debate will lead to a credible, publicized improvement in vaccine safety and— ultimately— in vaccine coverage.

Even prior to the book’s release, I have been met with a cascade of denunciations from a variety of journalists and columnists. Sadly, since these comments have come before the book’s release, it is clear that the journalists have not read the book nor the science behind it documented across hundreds of references. In fact most of the criticisms have focused on how thimerosal has been linked to autism. That is not the subject of the book, nor is that claimed within the book. These journalists have summarily rejected the possibility of any evidence of harm before reviewing the actual science or the content of the book.

It’s my hope now that we might move this debate to a higher plane. People who advocate for safer vaccines should not be marginalized or denounced as anti-vaccine. I am fiercely pro-vaccine. I had all six of my children vaccinated. I believe that vaccines have saved the lives of hundreds of millions of humans over the past century and that broad vaccine coverage is critical to public health. But I want our vaccines to be as safe as possible.

Studies show that a major threat to the kind of widespread vaccine coverage needed to protect global health is public doubt about vaccine safety and mistrust of vaccine regulators. Certain government officials and overworked journalists dismiss the public’s legitimate questions about thimerosal as the fruit of mindless paranoia promulgated by conspiracy theorists. On the contrary, compelling peer-reviewed science, from the 1930s on into today, supports the popular skepticism regarding thimerosal.

As we show in Thimerosal: Let the Science Speak, thimerosal is a potent neurotoxin that has never been proven safe, and is ineffective for use as a preservative in the first place. Concerns about thimerosal toxicity prompted the FDA, in 1982, to propose banning it in all over-the-counter, topical medications.[2] (There were many dozens of these, including products that many of us remember well, such as the red, skin-staining mercurochrome antiseptic ointment.) The ban was finally implemented in 1998.

Ironically, shortly after the FDA had first called for the removal of thimerosal from topical application, the CDC began dramatically increasing its use in injectable vaccines, in the late 1980s and early 1990s. Potential mercury exposure from vaccines more than doubled from a historical 100 micrograms to 237.5 micrograms by the age of two years. A child in the 1990s could have been exposed to as much as 62.5 micrograms of mercury all at once, contained across three different vaccines, during a single doctor visit at two, four, six, and/or fifteen months of age.[3]

In 1999, ongoing concern over thimerosal’s safety in vaccines finally spurred the American Academy of Pediatrics (AAP) and the U.S. Public Health agencies, which include the CDC, the FDA, the National Institutes of Health (NIH), and the Health Resources and Services Administration (HRSA), to call for its removal from childhood vaccines as a precautionary measure. The final thimerosal-containing lots of vaccines did not expire, however, until 2003. Although thimerosal was phased out in U.S. pediatric vaccines, elsewhere in the world, vaccines continue to contain this questionable preservative.

Just as thimerosal largely left the pediatric vaccine schedule, prenatal exposure to it increased, though, in an insidious and potentially even more dangerous fashion: through the flu vaccine. In 2002, the CDC began recommending annual flu vaccines for healthy infants between the ages of six and 23 months of age. Not long after, in 2004, the recommendations were extended to pregnant women in all stages of pregnancy. And in 2010, the CDC advised that every American, including pregnant women and young children, beginning at six months of age, get an annual flu shot. Many multi-dose flu vaccines contain thimerosal. American children born today, if their parents follow the annual flu shot guideline, may receive upwards of 187.5 micrograms of mercury by their eighth birthday. Although less than the 237.5 micrograms of potential vaccine-mercury exposure by age two, back in the 1990s, the potential—and intentional—prenatal exposure has become higher in the past decade than at any time in history.

The evidence of thimerosal’s neurotoxicity is so compelling, and the lack of any safety data so startling, that anyone who is actually willing to read the science and who believes in the capacity for scientific methods to determine empirical truths, must conclude that thimerosal can cause bodily injury including brain damage. The argument is not whether it causes autism, which is not clearly proven, although this curiously been the focus of recent criticism of the book (which no one had read to date). The issue is whether thimerosal is a neurotoxin and belongs in any medical products, including vaccines. Thimerosal has given us not only a public health peril, but also a journalistic crisis. The most troubling aspect of the thimerosal debate has been a widespread reluctance of science journalists to actually read the scientific literature, or to distinguish between established science and the scientific establishment. Instead, journalists have almost universally adopted the predictable talking points of government regulators and the vaccine industry. Dan Schulman wrote a piece for the Columbia Journalism Review blaming journalists’ fear and laziness for the crisis in a telling expose of this media scandal back in 2005. Schulman wrote:

Journalists agree that the thimerosal story is one of the most explosive they’ve ever encountered….Some reporters who have portrayed this as an ongoing scientific controversy have been discouraged by colleagues and their superiors from pursuing the story. A reporter for a major media outlet, who did not want to be identified for fear of retribution, told me that covering the thimerosal controversy had been nearly “career-ending” ….

The reporter has decided against pursuing stories on thimerosal, at least for the time being. “For some reason giving any sort of credence to the side that says there’s a legitimate question here—I don’t know how it becomes this untouchable story, I mean that’s what we do, so I don’t understand why this story is more touchy than any story I’ve ever done.”

In recent days, many respected science writers, without ever reading our book or talking to its authors, have chosen to vilify me personally as “anti-science” and “anti-vaccine,” rather than engaging in an honest thoughtful and open argument about the science. Phil Plait and Laura Helmut at Slate, Steven Salzberg at Forbes, Jeffrey Kluger at Time, Russell Saunders at the Daily Beast and Sean Long at Newsbusters are just some examples. All of these writers used similar talking points to criticize the book. The only thing these writers have in common is that none of them have read the book. They couldn’t have, because it doesn’t hit the bookstores until today.

I am rabidly pro-science. For 30 years as a litigator and environmental advocate, I have fought to make rigorous science the driver of public policy. I have fought on behalf of a scientific approach to policy in the global warming arena, in the tobacco wars and in my many battles with pesticide and chemical companies, with legal skirmishes ranging from the Hudson River to Alaska’s Cook Inlet, from the West Virginia coalfields to the Louisiana oil patch, from the Caribbean island of Vieques to Puget Sound. I have fought these battles on issues including acid rain, ozone, coal ash, particulates, PCBs, lead, mercury, hydrocarbons, pesticides and numerous other poisons that have been the subject of the hundreds of cases I’ve argued against polluters and their crooked “tobacco scientists” and biostitutes.

For many years, I’ve been puzzled by the bland and apparently baseless insistence by public health regulators and members of the press that it is safe to inject mercury—one of the world’s most neurotoxic elements—into young children and pregnant women. Their knee-jerk defense of thimerosal is all the more odd given that most U.S. vaccine makers have already switched to thimerosal-free injections in pediatric vaccines administered to American children. Two major vaccine manufacturers even made offers, back in 1999, to the CDC to produce completely thimerosal-free vaccines, in place of the thimerosal-preserved vaccines still available at that time after the official recommendation of their removal from the market. [4]The CDC declined the offer, and instead allowed the childhood vaccines preserved with thimerosal to stick around until their expiry four years later. The CDC’s refusal to allow or assist in the transition to thimerosal-free formulations is baffling.

We are publishing this book to make that task easier for the agency with regard to the multi-dose flu vaccines routinely administered these days, some 15 years later. We also hope the book will help dissuade the press from accepting the tired claim that anyone who questions thimerosal’s safety is “anti-science” and “anti-vaccine.”

This book, a meta-review essentially, does not pretend to answer the thorny question of whether thimerosal is a culprit in the autism epidemic. However, the abundant science on that topic, which we laid out in the documents we provided to the CDC and its sister agencies, is certainly cause for concern. A careful, objective consideration of the scientific literature on this topic demonstrates that, contrary to government pronouncements, a possible thimerosal-autism connection is far from a settled question. The fact that this topic is largely unresolved arises, in part, from the astonishing unwillingness of government agencies to open the treasure trove of vaccine safety data stored in the national Vaccine Safety Datalink database, or to encourage legitimate studies exploring the possibility that thimerosal might, in some cases, contribute to autism causation.

The role of journalism in a democracy requires that reporters do more than simply broadcast the point of view of the government and corporate officials. Science writers who have been grinding it out for decades against anti-science flat-earthers in the climate change wars should understand that a conscientious journalist cannot report on science simply by polling selected cohorts or government regulators. He or she must do the hard work of reading real science and asking provocative questions.

On June 28, 2005, a group of world-renowned scientists sent a letter to the New York Times chiding the paper for its practice of marginalizing scientists and others who explored the connection between environmental mercury and brain injury. The scientists were led by Dr. Ezra Susser, chair of the epidemiology department at Columbia’s Mailman School of Public Health, and other department members weighed in, including Dr. W. Ian Lipkin, Dr. Mady Hornig, a highly regarded neurologist, and epidemiologist Dr. Michaeline Bresnahan. These researchers wrote: “Whether mercury in any form has anything to do with [brain injury] can and should be resolved with rigorous studies and respectful discourse, not moral indictments and denunciations.”

The Times refused to print that letter. For those science writers, who have been engaging in personal and vitriolic attacks against me, I invite you now to meet me on the battlefield of true scientific debate. It’s time to elevate this argument over thimerosal, which has been based largely on poorly informed opinion, to civil discourse and rational argument. Just to be clear, the invitation is particularly for columnists Phil Plait, Laura Helmuth, Seth Mnookin, Steven Salzberg, Jeffrey Kluger, Kerry Lauerman, Russell Sanders, Sean Long, and Joan Walsh, plus any scientist or government regulator who wants to defend the continued use of thimerosal in vaccines.

[1] Due to the highly charged nature of this topic, some of those who contributed wish to remain anonymous, but researchers who have reviewed or consulted on this book include Dr. Irva Hertz-Picciotto, chief of the Division of Environmental and Occupational Health, Department of Public Health Sciences at the University of California, Davis; Dr. Richard Deth, professor of pharmacology at Northeastern University; and Dr. David Bellinger of Children’s Hospital Boston and the Harvard School of Public Health, whom we hired as an independent reviewer.

[2] U.S. National Archives and Records Administration, Office of the Federal Register. Status of certain additional over-the-counter drug category II and III active ingredients. Federal Register.1998 Apr; 63(77): 19799-19802.

[3] The book provides some graphics showing the potential ethylmercury exposure from thimerosal-preserved vaccines by certain ages in the 1990s and through today.

[4] Copies of these letters are available in my book.

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