By Anne Dachel
I listened to an interesting conversation between Barbara Loe Fisher of the National Vaccine Information Center and family medicine osteopathic physician, Dr. Joseph Mercola, that was released July 10, 2012.
The topic was “Merck Accused of Lying about Vaccine Effectiveness” and the lawsuit against Merck charging that the company falsified mumps vaccine test results to make it look like the vaccine is more effective than it really is.
Dr. Mercola pointed out that this was the same company (Merck) that VOLUNTARILY removed Vioxx from the market after it had killed 60,000 people. He said that internal documents revealed that Merck knew about the deadly side effects of Vioxx.
Barbara reported on the lawsuit filed by two former Merck employees, who allege that Merck was dishonest in their testing methods because they wanted to protect their sole source U.S. market of mumps vaccine in the MMR shot. The legal brief in the lawsuit is very strong, according to her. The question of federal oversight is critical here, yet the Dept of Justice seems very disinterested.
Mercola noted that the Justice Dept had been made aware of this but has done nothing was just another "confirmation of the enormous collusion between the federal government and the regulatory agencies and large multi-national corporations like Merck."
Mercola pointed out that Dr. Julie Gerberding, former head of the Centers for Disease Control and Prevention, is now head of the vaccine division at Merck and that the former head of the National Institute of Health is now CEO of Sanofi vaccines, calling it corruption and scandal. Barbara described the "public-private partnership" that now exists between the pharmaceutical industry and the regulatory agencies.
What really got my attention was something that Barbara Loe Fisher brought up during the discussion, namely that the NVIC has, for years, called for an INDEPENDENT, VACCINE SAFETY OVERSIGHT AGENCY—NOT CONNECTED WITH NIH, CDC, or any other federal agency. Instead, it would be truly independent, like a consumer protection agency.
I was intrigued by Barbara’s simple idea: if officials want to restore the rapidly eroding trust in the vaccine schedule, let’s have AN INDEPENDENT AGENCY with oversight authority. And by “independent,” I don’t mean people who have waivers because they also own stock in drug companies, or who made millions developing one of the vaccines on the mandated schedule, or anyone eyeing a future job in a drug company. I realize that eliminates thousands of possible candidates, but I’m sure others are available.
I asked Barbara about her idea and this is what she had to say:
Barbara, reports of unethical practices at the FDA are out from major news sources.
The Washington Post: “The Food and Drug Administration secretly monitored the personal e-mail of six employees after they warned Congress and the White House that the agency was approving medical devices that posed unacceptable risks to patients, according to a lawsuit filed this week.”
This hardly shores up any confidence in the claims by health officials that adding more and more vaccines to the childhood schedule is safe. Who’s overseeing the overseers? The most heated controversy in medicine today involves the claim by tens of thousands of parents that an unsafe, unchecked vaccine schedule left their children with autism.
Q: You have asked for an independent vaccine oversight agency for several years now, what has been the response from health officials?
A: Since the mid 1990's, NVIC has called for vaccine safety research to be made a national priority. We've advocated that independent researchers without financial or ideological conflicts of interest be funded to address gaps in vaccine safety science. From our experience with children, who died and were brain injured by DPT vaccine in the 1980's and early 90's, we knew that the only way to prevent vaccine injuries and deaths was to better understand biological mechanisms, identify high risk factors and evaluate whether there are long term health outcome differences between those children, who receive government recommended and mandated vaccines, and those, who do not. However, for two decades public health agencies have stubbornly refused to acknowledge vaccine risks or support this kind of research and vaccine safety science gaps have remained.
In April 2008, during my presentation at a National Vaccine Advisory Committee (NVAC) meeting, I suggested that an independent vaccine safety oversight agency should be established along the lines of the National Transportation Safety Board (NTSB). The NTSB independently investigates plane crashes and is separate from the Federal Aviation Administration, which is the federal agency responsible for regulation of the airline industry. The idea for an NTSB-like agency - or one that is at least independent from DHHS - to provide oversight on vaccine safety has been talked about privately for years by several advocacy organizations but has not been publicly discussed.
This time, with the help of Keystone Center (a professional public engagement facilitator), the idea of an independent vaccine safety oversight mechanism was discussed, among other options, at an April 2010 NVAC sponsored meeting of vaccine stakeholder representatives in Salt Lake City. It was also publicly discussed in subsequent April 2011 NVAC meetings in Washington, DC. and, additionally, NVIC submitted written comments as did other advocacy groups asking for more independent, transparent vaccine safety oversight by government.
However, in February 2012, when DHHS published the final “white paper” on “The U.S. Vaccine Safety System,” the idea of independent oversight on the federal health agencies responsible for vaccine development, regulation, policymaking and promotion was rejected in favor of protecting the status quo.
Q: What type of person do you envision in this agency?
A: The person to head up this agency would have to be someone like the late Bernadine Healy, M.D., the first woman to become head of NIH, who was intellectually honest, professionally credentialed, courageous and committed to pursuing truth even if it might turn out to be inconvenient. An advisory committee composed of a mix of health care professionals and consumers without financial ties to vaccine manufacturers or federal health agencies, who are nominated by a potential advisory committee member’s Senator or Representative and appointed by the President, could provide additional oversight on the vaccine safety oversight agency's operation.
Q: What authority would this group have?
A: The agency would have to report directly to the President and the public without interference from DHHS. Potential agency responsibilities, some of which I suggested at the Salt Lake City meeting, are: oversight of the Vaccine Adverse Events Reporting System (VAERS) jointly operated by FDA and CDC; oversight of investigations of vaccine safety signals generated by VAERS; oversight of vaccine risk investigations conducted by DHHS (such as Vaccine Safety Datalink studies); participation in the setting of priorities for funding of major vaccine safety studies and oversight to ensure methodological, operational and ethical standards are met; inquiry into and analysis of emerging vaccine safety issues of concern to the public.
The vaccine safety oversight agency would have the legal authority to (1) independently investigate identified vaccine safety signals that affect the public health and safety and involve federal health agencies and/or pharmaceutical companies doing business with federal health agencies; (2) make recommendations to the President; publish reports released to the public.
Q: What will happen without such an agency?
A: Public opinion polls have indicated that parents place vaccine and prescription drug safety at the top of their list of health concerns for their children. The cozy financial relationship that Congress has allowed DHHS to have with pharmaceutical companies marketing vaccines after Congress gave a liability shield to those companies in 1986, means that there is no independent oversight on vaccine safety in the U.S.
This very lucrative “public-private” business relationship has grown significantly since Bioshield/Pandemic Preparedness legislation was passed by Congress in 2004 and 2005. This kind of “one hand washes the other” type of relationship is inappropriate on so many levels because there is no public accountability by drug companies making huge profits and government health officials helping them do it by fast tracking new vaccines to licensure and pushing vaccine use mandates.
The global communications revolution that has put computers and cell phones into the hands of people around the world means that parents have much more information at their fingertips than they had in previous decades. People are sharing information and becoming educated about vaccination and health and they know it is a conflict of interest for the same government health officials to be charged with the job of developing new vaccines, regulating drug companies marketing vaccines, making vaccine policy recommendations and promoting vaccine mandates, to also be charged with the responsibility of monitoring vaccine safety. Without an independent vaccine safety oversight agency that actively engages and involves the public, the public is going to continue to justifiably lose faith in the integrity of the vaccination system.
Q: Is this a reasonable request?
A: Yes, it is an entirely reasonable and necessary request to protect the public health and safety.
Q: What other changes need to be made in how we test, approve, and mandate vaccines?
A: 1) For starters, Congress should repeal the portion of the 1997 FDA Modernization Act (FDAMA) that allows drug companies to pay the FDA to “fast-track” licensing of new vaccines. That law was originally only supposed to include drugs but, toward the end of the legislative process, drug company lobbyists on Capitol Hill got vaccines thrown into the law.
Second, the FDA should raise the licensing standards for new vaccines and require drug companies pre-licensure to:
- conduct vaccine trials with true (inactive) placebos given to the control group;
- test the new vaccine in the indicated vaccine use age group without other vaccines being given simultaneously;
- compare the new vaccine being given singly against a group of children given the new vaccine simultaneously with every other vaccine licensed and recommended for that age group;
- include groups of individuals in pre-licensure trials that reflect the diversity of the population for which the vaccine will be recommended and mandated OR include labeling information that indicates the vaccine has NOT been studied in individuals, who are (1) acutely ill with a coinciding viral or bacterial infection; (2) using antibiotics or other prescription medications; (3) have a personal or family history of vaccine reactions, injuries and death; (4) are chronically ill or disabled with a personal or family history of immune and brain dysfunction, severe allergies or neurodevelopmental disorders; (5) babies born prematurely or weighing under six pounds;
- Use disease endpoints for demonstration of effectiveness instead of being allowed to use “surrogate endpoints” that may or may not reflect the true effectiveness of the vaccine in preventing disease;
- In labeling, clearly describe the manufacturing techniques used to prepare the vaccine and the biological mechanisms affecting body systems for each vaccine ingredient and residual component (such as potential adventitious agents, including genetically modified animal and human DNA).
There are many improvements that need to be made in post-marketing surveillance of existing and new vaccines by the FDA and CDC. There is an urgent need for much better follow-up of vaccine injury and death reports by health officials, who do not unscientifically and dangerously assume “coincidence” rather than assuming potential causation in the absence of a better explanation. A person is less likely to assume “coincidence” if his or her sole job is to monitor vaccines for safety rather than also be charged with developing, regulating and promoting vaccine mandates.
As far as vaccine mandates go, the National Vaccine Information Center has been on the record since 1982 as opposing forced vaccine use in the U.S. because we defend the ethical principle of informed consent to medical risk taking. The human right to voluntarily decide what you are willing to risk your life and your child’s life for when it comes to medical interventions and use of pharmaceutical products, like vaccines, must be protected at all costs. Every state public health law should provide non-medical vaccine exemptions, including the religious and conscientious belief exemption, without restrictions or sanctions imposed on anyone taking vaccine exemptions.
The freedom to make voluntary vaccine choices in America serves as a counterweight to the unlimited profit-making by multi-national pharmaceutical corporations exploiting the lucrative, liability-free vaccine mandates that exist in ours, the third largest nation in the world. Freedom of choice also places limits on the power of doctors, who are employed by government health agencies, to force citizens to use an unlimited number of vaccines without any accountability for the potential harm those vaccines are doing to children and adults, who are never counted in the vaccine benefit-risk analyses published by government health agencies promoting “no exceptions” vaccine mandates.
I urge every parent, who wants to protect the legal right to make vaccine choices, to become a user of NVIC’s free online Advocacy Portal http://www.nvicadvocacy.org/and get involved in defending non-medical vaccine exemptions in state public health laws.