by Dr. Sherri Tenpenny, DO, AOBNMM, ABIHM
The FDA estimated that more than 27,000 cases of acute myocardial infarction and sudden cardiac death occurred in the USA between 1999 and 2003 due to the anti-inflammatory medication, Vioxx. Could this have been a direct result of Merck changing its core values from “People above Profits,” as described in Jim Collins’ 1994 book, Built to Last, to “Profits Above All Else”? Stock values tumbled immediately and more bloodletting followed as the lawsuits filed against Merck poured in.
Highlights from an editorial in the Lancet regarding Merck and the FDA include the following statements:
“…[the Vioxx issue] points to astonishing failures in Merck’s internal systems of post-marketing surveillance, as well as lethal weaknesses in the Food and Drug Administration’s regulatory oversight.”
“But, too often, the FDA sees and continues to see the pharmaceutical industry as its customer—a vital source of funding for its activities—and not as a sector of society in need of strong regulation.”
“With Vioxx, Merck and the FDA acted out of ruthless, short-sighted and irresponsible self-interest.”
After three years of negotiations, Merck agreed to pay $4.85 billion to settle 27,000 lawsuits by people who claim they or their family members suffered injury or died after taking the drug, according to two lawyers with direct knowledge of the matter.
But what about their other faulty products? Shouldn’t Merck, along with other vaccine manufacturers, be held accountable for damage done by their vaccines? Vaccines have known problems. Even back in 2002, CDC’s introductory statement in its General Recommendations of Vaccinations states, “[Both] benefits and risks are associated with using all immunobiologics. No vaccine is completely safe or 100% effective.” In 2011, the U.S. Supreme Court agreed that vaccines are “unavoidably unsafe.”
But is admitting that vaccines have problems an excuse for continuing to use a product shown to be associated with serious consequences? For example, it has been estimated that the hepatitis B vaccine is associated with a threefold increase in the incidence of MS within the three years following vaccination. Merck, the vaccine’s manufacturer, is no doubt aware of this study. More recently, Merck is facing a slew of controversies over its Measles-Mumps-Rubella (MMR) vaccine following numerous allegations of wrongdoing from different parties in the medical field, including two former Merck scientists-turned-whistleblowers. A third whistleblower, this one a scientist at the Centers for Disease Control, also promises to bring Merck grief following his confession of misconduct involving the same MMR vaccine. According to an article posted in November, 2014 in the HuffingtonPost:
The controversies will find Merck defending itself and its vaccine in at least two federal court cases after a U.S. District judge earlier this month threw out Merck’s attempts at dismissal. Merck now faces federal charges of fraud from the whistleblowers, a vaccine competitor and doctors in New Jersey and New York. Merck could also need to defend itself in Congress: The staff of representative Bill Posey (R-Fla) — a longstanding critic of the CDC interested in an alleged link between vaccines and autism — is now reviewing some 1,000 documents that the CDC whistleblower turned over to them.
The first court case, United States v. Merck & Co., stems from claims by two former Merck scientists that Merck “fraudulently misled the government and omitted, concealed, and adulterated material information regarding the efficacy of its mumps vaccine in violation of the FCA [False Claims Act].“
According to the whistleblowers’ court documents, Merck’s misconduct was far-ranging: It “failed to disclose that its mumps vaccine was not as effective as Merck represented, (ii) used improper testing techniques, (iii) manipulated testing methodology, (iv) abandoned undesirable test results, (v) falsified test data, (vi) failed to adequately investigate and report the diminished efficacy of its mumps vaccine, (vii) falsely verified that each manufacturing lot of mumps vaccine would be as effective as identified in the labeling, (viii) falsely certified the accuracy of applications filed with the FDA, (ix) falsely certified compliance with the terms of the CDC purchase contract, (x) engaged in the fraud and concealment describe herein for the purpose of illegally monopolizing the U.S. market for mumps vaccine, (xi) mislabeled, misbranded, and falsely certified its mumps vaccine, and (xii) engaged in the other acts described herein to conceal the diminished efficacy of the vaccine the government was purchasing.” (emphasis added)
Does Merck, or the other vaccine manufacturers, have any concern about vaccine quality? With the protection conferred by the National Vaccine Injury Compensation Act and the PREP Act, will there be more allegations in the future about their poor quality, high risk products?
What is the National Vaccine Injury Compensation Program?
The NVICP, a “no-fault” compensation system, was passed in 1986 to shield the pharmaceutical industry from civil litigation due to problems associated with vaccines. Under the law, families of vaccine-injured persons are required to file a petition which may be heard by a Special Master in the Federal Court of Claims, commonly referred to as the Vaccine Court. Successful claims are paid from a Trust Fund that is managed by the Department of Health and Human Services, with Justice Department attorneys acting as the legal representatives of the Fund. To date, nearly $3.1b has been paid to petitioners and their attorneys. However, it is estimated less than 25% of those who qualify for a hearing actually receive compensation.
Processing a claim can take up to 10 years, and in the end, no blame or culpability is assigned. In the mean time, the heartbreak continues, medical bills pile up and more children harmed every day to due to government protection of products that are believed to be the sterling backbones of our country’s public health policy.
Who can parents and vaccine-injured adults hold accountable for injuries caused by vaccines? The system is designed so that no one—neither a person nor an entity—can be tagged with accountability:
- Not the vaccine manufacturer.
- Not the doctor who recommends the vaccines nor the nurse or other medical person who administers them.
- Not the Advisory Committee of Immunization Practices members (ACIP), an appointed group with connections to drug manufacturers, the “experts” who approve and add the vaccine to the pediatric schedule.
- Not the Institute of Medicine members (IOM) who perpetuate the mantra “vaccines are safe and effective,” stonewalling opportunities for change and improvement.
- Not state legislators who add requirements to school schedules.
- Not school administrators who refuse entrance unless a child has been injected with 49 doses of 16 different vaccines by kindergarten.
- Not employers who require healthcare workers to get flu shots to keep their jobs.
- Not the U.S. military who require members to receive every vaccine before being allowed to serve our country.
- Not the Department of Immigration who now require vaccines for a person to become an American citizen.
The only person blamed if a vaccine injury occurs is the vaccine recipient. They are at fault for being genetically defective and unable to tolerate the onslaught of heavy metals, animal DNA, cells from aborted fetuses, detergents and a mixture of 67 different chemicals, including known carcinogens.
If it seems inconceivable that decision makers and people in power would point an accusatory finger at the injured party – especially if the injured person is a child – the following, from the chapter on pertussis (pg.80) in 6th Edition of The Pink Book, a CDC publication on vaccine-preventable infections:
There is no distinct syndrome from vaccine administration, and therefore, many temporally associated adverse events probably represent background illness rather than illness caused by the vaccine…The DTaP may stimulate or precipitate inevitable symptoms of underlying CNS disorder, such as seizures, infantile spasms, epilepsy or SIDS. By chance alone, some of these cases will seem to be temporally related to DTaP.”
In other words, the condition, including SIDS – death – were going to happen anyway. It was not the vaccine; the problem lies with the defective human. Notably, this section has been removed from the current 12th Edition of the Pink Book.
Removing Vaccine Manufacturer Protection
A cursory review of drug package inserts shows a long list of potential side effects and complications. If one of those complications becomes widespread, the FDA initiates a product recall. The company is held responsible for the injuries caused by its product. Case in point: Merck regarding Vioxx.
Why, then, are vaccine manufacturers, including Merck, not held accountable for damages caused by their products? Why do a laws exist that protect the pharmaceutical industry from accountability—and direct liability—for one of its most highly used products?
The pharmaceutical industry claims that vaccines are “not profitable.” But the truth is that annual vaccine sales have gone from about $2 billion in 1982, …to $8 billion in 2003… to $24B in 2013. And the World Health Organization (WHO) projects that the global annual sales for vaccines will be $100B by 2025. The WHO admits:
“Vaccines are an engine for the pharmaceutical industry.”
Global pharmaceutical sales reached an all-time high of approximately $980 billion in 2013 and was expected to top $1 trillion in 2014. Removing vaccine exemptions and the right to refuse this product will open the door even wider for drug company profits. They have no incentive to produce a safe product. And they benefit from both sides: sale of vaccines and a windfall of profits on the sale of drugs to treat the side effects created by the vaccines, such as asthma, allergies, diabetes, seizures and even cancer.
Merck was taken to task for injuries caused by Vioxx. The vaccine manufacturers must be pay for damages caused by their “unavoidably unsafe” products. Being held financially accountable for heart attacks is no different than being held financially accountable for vaccine injuries. A substantial body of scientific research in medical and scientific publications report the injuries and life time illnesses caused by vaccines in both children and adults.
Now is the time for the Trial Lawyer Association to step up in, reexamine, revamp and find a way to repeal an outdated, 1986 National Vaccine Injury Act.
(This article has been updated. Originally published on DrTenpenny.com in 2009)