Vaccine Safety & Scientific Integrity

Why Looking at Vaccine Safety and Scientific Integrity is So Important in 2017 

January 16, 2017:  It is my observation that most people never give a second thought to the safety of the drugs their doctors recommend.  Most people assume that because drugs including vaccines, are FDA approved they are safe. And most medical professionals trust both the federal regulators and their medical trade associations to give them guidance that will not harm their patients. There are several issues that set vaccines apart from other drugs, and which should require a higher ethical standard for the research and safety oversight.  Sadly, the opposite often seems to be true.  As President Elect Trump comes into office, with a discussion of ‘draining the swamp’ this issue is certainly one that should be addressed. 

What sets vaccines apart from other drugs are five issues:

1 – Liability protection

2 – Mandates

3 – Unresolved Controversies

4 – Coordinated efforts between government, industry, and trade associations.

5 – Coordinating censoring of media by industry and government

Liability Protection:  In 1999, when I first began looking at vaccine safety while working for Congress, I would learn that even the most diligent of my colleagues were vaccinating their babies simply because the pediatrician recommended it. Most had no clue that neither the health professional who administered the vaccine, nor the vaccine manufacturer who produced the product held liability for serious life altering adverse effects including death. Just over 27 years ago Congress took away your Constitutional right to seek legal recourse in the civil tort system for product injury.  Instead there is a federal compensation program that by most accounts is not working as Congress intended, but Congress has done no oversight since 2003.

Most of us had never taken the time to read the package insert of the vaccines given to our babies, and none of us knew that the FDA had continued to allow the use of 25 micrograms of the mercury preservative, thimerosal to be injected into babies the day they were born with the birth dose of the Hepatitis B vaccine, even though the FDA’s OTC branch had moved to ban thimerosal as a topical ointment a decade before because of concerns about mercury exposure and a lack of safety data.  Most do not know that all these years later, with all attention paid to the issue, in 2017, the FDA can still not tell you what a safe exposure level to injected thimerosal is for any age group, much less infants and the unborn and yet they continue to allow it to be used in vaccines, including those administered to infants and pregnant women.

As an aside to the main topic, it doesn’t matter what you hear on the news, unbiased experts will provide that every form of mercury has the potential to do harm including medical exposures. In the human body, mercury gravitates to three organs in the body the kidneys, the cardiovascular system and the brain. The unborn and the newly born are the most vulnerable to injury from exposure.

Mandates:  Vaccines hold a unique place in medicine – they are the only medications mandated by the states for school participation based on recommendations of the federal government. And since the Clinton Administration, families on federal assistance (all except housing) must show proof their children’s vaccines are up to date. This means, that the government has taken medical decision making out of the hands of parents. Yes, all states offer medical exemptions, but religious exemptions are now under attack, and in California, they have been eliminated. Further mandates are happening in hospital systems across the country – refusing the annual flu shot is ground for dismissal. Military members and first responders all have vaccine mandates.

Unresolved Controversies:  There are two ongoing whistleblower issues related to the MMR vaccine manufactured by Merck.  One involves a CDC employee who came forward two years ago stating that CDC employees had discovered the signal of a vaccine injury in a study based on the timing of the administration of the MMR and rather than publish this finding and do further research, changed the study protocol midstream with the express purpose of hiding the finding and went so far as to destroy documents, in direct violation of federal document preservation laws.  The second whistleblower issue also about the MMR, and is a corporate whistleblower who claims that Merck knew the mumps component was losing effect and yet covered this up, defrauded the government, to keep their corner on the measles vaccine market in the USA.  Yes, Merck, the same company who hid from the FDA the cardiovascular risks associated with VIOXX and who hired the former CDC Director Julie Gerberding to run their Vaccine Division not long after she left the CDC.

Merck isn’t the only controversial company with questionable ethics.  GlaxoSmithKline has a long history of misdeeds the latest of which is that they pled guilty to criminal charges in the largest US health care fraud case in history and agreed to pay $3 billion in fines in the United States for paying doctors to prescribe potentially dangerous drugs to children and adults that were risky.

Another controversy is the still unresolved case of Poul Thorsen, the Danish researcher indicted for 22 counts of money laundering and wire fraud associated with the theft of over $1million from a CDC grant through which vaccine safety studies used in the Vaccine Injury Compensation Program were conducted.  So far, the US Department of State and Department of Justice have failed to obtain his extradition from Denmark where he continues to work at a hospital.

Coordinated efforts between government, industry, and trade associations: One of the most disturbing facets of this entire issue is the extensive coordination between government, industry and the trade associations.  Let me give you an example.  The issue of thimerosal in infant vaccines.  The government quickly began doing some research.  Because of an ongoing contractual agreement with Health Maintenance Organizations (HMOs) like Kaiser Permanente on the west coast, the CDC had access to 3-5 percent of medical records of Americans through which they do epidemiological reviews of vaccine questions.

I’ll set aside for this explanation that the CDC staffer tasked with doing the job and the person supervising him found a serious risk and failed to write it up, instead modifying the query to water down the findings.  I’ll also set aside the fact that while doing this study the CDC staffer was negotiating a job with a vaccine maker, a clear ethical violation. The CDC called a closed-door meeting that excluded the public, Congress, and yet included advisors who had ties to vaccine makers, as well as leadership of the pediatric physicians’ trade association – which gets significant funding through ad revenue from industry in their journals. During the meeting (at Simpsonwood), at least one of the advisors called in by the CDC was calling a vaccine maker and giving them updates during the meeting.

Four years later, after the CDC staffer had taken his job in Europe with a vaccine maker, outside the reach of a Congressional subpoena, the CDC staff kept getting their article rejected by prestigious medical journals, so they asked their division chief to write a letter to the editor of the journal Pediatrics and convince him to publish the paper.  Which Dr. Cordero did.

Coordinated censoring of media by industry and government:  Frustrated with media coverage of families fighting for safer vaccines, then HHS Secretary Sebellius went so far as to send a message to media outlets to stop giving the parents air time; and an orchestrated effort to bully parents into submission commenced – labeling everyone who dared question their safety as ‘anti-vaccine.’  Having been on the inside of this issue for 17 years, I have seen time and again the organized effort to keep a balanced discussion on the topic from taking place. Every article that talks about parents concerned about vaccine side effects labels them ‘anti-vaccine’.  We saw this again last week when Robert F. Kennedy, Jr. met with President elect Donald Trump to talk about a Vaccine Safety and Scientific Integrity Commission.

In conclusion, I often have heard from people I talk to about the topic, “I had the flu shot and I didn’t have a reaction.” Or, “my kid got all their shots and didn’t suffer any ill effects.”  And to that I say, “Hallelujah!”  With over 330 million Americans, we cannot measure drug safety on our own personal experience. We need the best scientific analysis, done by the best experts who are willing to give us the truth, even when the news is negative.  To date, Americans have not gotten the ‘best scientific analysis’ or ‘the best experts’ or even ‘the truth’.

We deserve better.  We need to demand better.