The 1986 National Childhood Vaccine Injury Act and Conflicts of Interest

The 1986 National Childhood Vaccine Injury Act and Conflicts of Interest

Never before have there been so many editorials, articles, commentaries, government, and media efforts at compelled speech and overt censoring of anyone who challenges the legitimacy of the artificial constructs that vaccines are safe and effective. Dozens of physicians, toxicologists, immunologists, investigative journalists, and victims of vaccine injury have spent countless hours researching the actual scientific data and have shown convincingly that vaccines are neither proven safe nor effective. There are at least three women physicians who have more than fifteen thousand hours of research each into this topic and  they have all come to the same conclusion—that mandatory vaccines are the single greatest public health fraud of the twentieth and twenty-first centuries, causing the death and injury of countless babies, toddlers, and infants. However, vaccine manufacturers, working in cooperation with the CDC, are mandating more and more vaccines. It is a pure profit motive for them and for the physicians using vaccines, all because of one important law. The 1986 National Childhood Vaccine Injury Act (NCVIA), signed into law by Ronald Reagan, has been interpreted to allow vaccine manufacturers to be indemnified or held harmless no matter how many deaths or injuries. The other part of the story has to do with something deceptive to the point of nefariousness where a cabal of government officials or legislators and members of the pharmaceutical industry conspired to create this law knowing full well they knew the pharmaceutical companies would never bring these vaccines on the market if they knew they would be held liable.

History

The NCVIA was Congress’s attempt to balance the goals for victim injury compensation, stable vaccine supply, and the creation of safer vaccines. Scientists, including Dr. Jonas Salk, the developer of the polio vaccine, warned Congress of the danger of eliminating tort liability. Dr. Salk testified that doing so would remove the incentive for manufacturers and the scientific community to improve existing vaccines and remove the incentive to change policy when equally effective but safer vaccines already exist. The pharmaceutical and medical communities, on the other hand, opposed any liability for vaccine manufacturers, citing threats to the vaccine supply and public health, pushing for a no-fault administrative system to be the exclusive remedy for victims. 

While the House Committee on Energy and Commerce considered proposals that would have explicitly preempted all design defect claims, ultimately, “the final version did not contain such provisions. By rejecting language that would have barred all design defect claims, Congress showed its intent to permit courts to decide on a case-by-case basis which side effects were genuinely ‘unavoidable.’” However, the Supreme Court, in Bruesewitz v. Wyeth, did what Congress failed to do—indemnified vaccine manufacturers from design defects. Justice Elena Kagan recused herself from the decision because of her involvement in the case when she was solicitor general, representing the United States government. Her position, the position of the Obama administration—supporting Wyeth Laboratories. Chief Justice John Roberts initially recused himself because of his interest in Wyeth, but sold his stock in order to participate in the decision. The two dissenting justices, Ruth Ginsberg and Sonia Sotomayor, voiced the same considerations of Congress at the time the bill was passed, the same considerations Dr. Salk testified to—that the language of the law did not explicitly preempt all design defect claims and that manufacturers will “have little or no incentive to improve the designs of vaccines.”

Challenging the Assumptions

The public is repeatedly told that vaccines are safe and effective. Dr. Sherri Tenpenny, one female physician who has spent countless hours researching the actual scientific data, goes back to basics to show how the words “safe” and “effective”— words that play like a broken record in the public discourse on vaccines—do not reflect the reality. Dr. Tenpenny challenges the assumptions that vaccines are safe and effective, using the dictionary definitions of these words to demonstrate that vaccines are not “safe” and while they are “effective” in one sense, that effectiveness “is not a synonym for protection.”

“Safe” means (1) Giving protection, (2) Involving no risk, and being (3) Trustworthy/Causing no damage. But it is widely known that vaccines cause damage. The National Vaccine Injury Compensation Program pays out billions of dollars on claims to victims of vaccines. Unfortunately, despite those billions, many victims remain undercompensated or uncompensated. It is also known that vaccines involve risk—every packet of vaccine contains information about that risk. As far as giving protection, Dr. Tenpenny discusses problems with the studies of vaccines. She emphasizes that safety studies do not use a true placebo group. In conventional medicine, she explains, the double blind placebo controlled study is the gold standard. However, vaccine trials use the word comparator instead of placebo, comparing side effects. The trials (1) Don’t use inert substances, (2) Include three injections to create an antibody response, not taking into account the side effects of people who drop out, and (3) Only enroll healthy children and healthy adults, so while vaccines are most recommended for the most susceptible children, those children have never been tested. 

After demonstrating that vaccines are not “safe” in the way the public is led to believe, Dr. Tenpenny challenges the assumption that they are “effective.” “Effective” means (1) Adequate to accomplish a purpose (2) Producing an intended or expected result (3) Fulfilling a specified function. Vaccines are effective because they accomplish the purpose of injecting foreign matter into the body. And when a blood test determines if that matter caused your body to generate an antibody, it fulfilled specified function. However, “the presence of an antibody doesn’t guarantee you from getting an illness, so effective is not a synonym for protective or protection.” Dr. Tenpenny’s challenges to the legitimacy of the artificial constructs that vaccines are safe and effective need to be addressed, not censored.

Conflicts of Interest

Our Representatives or the Representatives of the Pharmaceutical Industry?

The bill NCVIA was introduced in the House by Rep. Henry Waxman who, from 1989-2016, raised over 1.1 million dollars from health professionals (almost double the amount he raised from the next largest industry). The NCVIA had twenty-three co-sponsors in the House, many of whom received campaign contributions from pharmaceutical companies such as Merck and Pfizer. In 1985-86, Merck contributed to Rep. Doug Walgren, Rep. Thomas Luken, Rep. James Scheuer, Rep. Richard Shelby, Rep. Norman Lent, and Rep. Edward Madigan. And Pfizer contributed to 15 of the 23 co-sponsors! One of the bills co-sponsors, Rep. John Dingell, raised over 1.3 million dollars from health professionals from 1989-2014. That’s less than Rep. Ron Wyden’s 1.6 million from 1989-2016. One of Rep. Ed Markey’s top contributors over the course of his career has been DLA Piper, a multinational law firm, that lobbies on behalf of its health industry clients. And so on and so on. While the original bill introduced by Rep. Waxman did not pass the Senate, another version of the bill was introduced in the Senate by Paula Hawkins. In 1985-86, Pfizer made a $1,000 contribution to her re-election campaign. Wyeth chipped in $500.

And it’s not just the money that members of Congress receive while in office.  Upon leaving, many members find cushy employment as senior advisors at lobbying firms. Rep. Waxman became chairman of his son’s consulting firm, focusing on undisclosed clients in the healthcare industry. Rep. Norman Lent is currently a lobbyist at Arent Fox LLP.  Rep. James Florio landed at Donald Sico & Co., lobbying on behalf of the Healthcare Institute of New Jersey. Rep. Doug Walgren went from Drinker, Biddle & Reath to Wiley Rein where he would lobby on health care. And so on and so on.

Our FDA and CDC or agencies of the Pharmaceutical Companies?

In 2000, The House of Representatives Committee on Government Reform held a hearing to examine vaccine policy, focusing on how the Centers for Disease Control and Prevention and the Food and Drug Administration handled the rotavirus vaccine. Rep. Burton questioned whether the agencies were “vigilant enough” and whether they were “influenced by the pharmaceutical industry.” In acknowledging that families and doctors need to have confidence that vaccines are “safe and effective,” Rep. Burton expresses concern that the chair of the FDA and the members of the CDC advisory committees making the decisions own stock in the drug companies that make the vaccines; that individuals on both advisory committees own patents for vaccines under consideration; that three out of the five members of the FDA’s advisory committee who voted for the rotavirus vaccine had conflicts of interest waived; that the CDC grants conflict of interest waivers to every member of their advisory committee a year at a time, and allows full participation in the discussions leading up to a vote by every member, whether they have a financial state in the decision or not.

Rep. Burton cites Dr. John Modlin, Dr. Paul Offit, Dr. Patricia Ferrieri, Dr. Neal Halsey, Dr. Harry Greenberg as examples of advisory committee members who owned stock in the drug companies that make the vaccines. “How confident can we be in a system when the agency seems to feel that the number of experts is so few around the country that everyone has a conflict and thus waivers must be granted? It almost appears that there is an ‘old boys network’ of vaccine advisors that rotate between the CDC and FDA,” the representative said in his opening remarks. The answer is…we can’t be confident. 

Dr. Offit sat on the CDC’s Advisory Committee on Immunization Practices (ACIP) from 1998-2003. During that time, he voted three times in favor of the rotavirus vaccine, including the decision to add this vaccine to the Vaccines For Children program. All the while, Offit was also being paid by Merck to develop a rotavirus vaccine, profiting several million dollars when he later sold his share in the patent of that vaccine. And in the years since, former heads of the CDC have landed jobs at the same pharmaceutical companies that they were supposed to be regulating, like Julie Gerberding’s move to Merck in 2009.

While Rep. Burton argued that, “No individual who stands to gain financially from the decisions regarding vaccines that may be mandated for use should be participating in the discussion or policymaking for vaccines,” Rep. Waxman, despite indicating that he would keep an open mind, stated, “But from what I’ve seen, I have my doubts that the chairman will be able to demonstrate that vaccine decisions have been tainted by scandal.” 

Rep. Waxman seems presents these conflicts of interest as benign. “If we’re going to have a requirement that no one own stocks in companies that may benefit from our decisions indirectly, then we ought to say it. But we have not said that, and therefore, people have not violated any rule because they simply have financial holdings.” 

Yes, Rep. Waxman, you have not said that. And yes, Rep. Waxman, you should say that. There should be a rule that people who own stock in companies that benefit from not only your decisions, but their decisions, should not be making decisions, especially decisions mandating Americans inject foreign matter into their bodies, especially when these conflicts of interests are not disclosed to the public. There are laws against insider trading. Payola laws in broadcasting. Yet, politicians and government employees are getting rich off the laws and decisions they make impacting the lives of the American public.

Conclusion

While the CDC was established by Congress as an independent, nonprofit organization, to support a critical health protection mission, Dunn & Bradstreet, exposed the agency as a for-profit corporation. The CDC states that it “works with the private sector because public-private partnerships advance CDC’s mission of protecting Americans.” The CDC has a monetary interest in vaccines. The people working at the CDC have a monetary interest in vaccines. The Congressmen who receive campaign donations and go on to work on K Street have a monetary interest in vaccines. Like Rep. Burton, said, “It almost appears that there is an ‘old boys network’…” 

In one of her lectures on vaccines, Dr. Sherri Tenpenny said, “They consider it unethical to give a vaccine to one group and hold from another group therefore the placebo should have some benefit, it should be a vaccine.” But isn’t it unethical to hold trials other than gold standard trials, to inject children with foreign matter, to allow the pharmaceutical companies to escape liability, for children to be permanently disabled or die from their vaccine exposures and not be compensated for injury? Isn’t it unethical for politicians and government employees to make decisions impacting the lives of Americans while they are making thousands, sometimes millions of dollars from the companies they are supposed to be regulating? Chief Justice John Roberts didn’t seem to think it was proper to hold stock in a company and make a decision that will impact that company. And if Henry Waxman is right about something, maybe it is not illegal. During that hearing in 2000, even Marilyn Glynn, General Counsel for the Office of Government Ethics admitted, “it might very well not be a conflict under the criminal conflict of interest statute…But believe me, of course there are certainly appearance concerns…” “Appearance concerns.” Tell that to the countless babies, toddlers, and infants who have little recourse against the vaccine manufacturers and the politicians who are profiting from their suffering.