(The Defender)—Drug manufacturer Merck misrepresented the efficacy of its mumps vaccine for years, “overfilling” the vaccine with live mumps virus to meet efficacy targets despite the lack of safety testing — and the practice may be continuing today.
Merck appears to have concealed the practice from public health agencies, which have taken no action to stop it.
Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense, joined “The Defender In-Depth” this week to discuss the revelations, which stem from a lawsuit two Merck whistleblowers filed in 2010 under the False Claims Act.
The 3rd Circuit U.S. Court of Appeals in Philadelphia heard oral arguments in the case on July 9.
According to Hooker, the Merck measles, mumps rubella vaccine, MMR II — the only mumps vaccine licensed in the U.S. and listed on the childhood vaccine schedule for 12- to 18-month-olds — may contain up to 4 times the approved concentration of live mumps virus.
A two-part deposition by Dr. David Kessler, former head of the U.S. Food and Drug Administration (FDA), also indicates that Merck, rather than informing regulators that it was “overfilling” its MMR vaccine, relied on passive surveillance — reports from parents regarding vaccine reactions in their children — to identify possible safety signals.
‘We do not know how this is going to affect the body’
In this week’s interview, Hooker emphasized that vaccine dosages with a higher concentration of live mumps virus were never tested for safety or efficacy.
“What is in the Merck MMR II vaccine is not what is being reported,” Hooker said. “This is a live virus vaccine, and these viruses are at higher concentrations. and we know, as far as the mumps vaccine, that the concentrations that are in the vials have never been tested for safety.”
Hooker explained that guidelines for the amount of live virus in the MMR II vaccine were last changed in 1999, “as a result of an FDA action that showed that the mumps portion of the vaccine was losing potency over its sort of two-year [shelf life] before the vaccine expired.”
This prompted Merck to “change the mumps concentration of the vaccine,” Hooker said. However, Merck did so without informing health regulators or the public, gaining regulatory approval or performing safety tests.
“The mumps portion of the vaccine lost its potency to an ineffective and an unacceptable endpoint, and the FDA notified Merck of this in 1998,” Hooker said. “In order to compensate for this, Merck merely did something that is called ‘overfill’ to the virus, overfilled the vials to a higher starting level.”
“They started out with …100,000 TCID50,” Hooker said — referring to the measure of the number of viral particles in a vaccine. “They changed that to 160,000 active virus particles in 1999.”
Hooker added:
“What that means from a production standpoint is that the exact middle concentration of virus is 160,000. The vials can deviate as much as four times over that, and they can be as high as 600,000 viral particles, or they can be as low as 100,000 viral particles.”
This poses a public health risk, Hooker said, because concentrations higher than 160,000 viral particles are “far beyond anything that has ever been tested for safety.”
“Safety testing has only been done to that lower limit of 160,000,” Hooker said. “In order to achieve immunity, according to the FDA, you only need 20,000 … virus particles. So, looking at that, Merck is overfilling the vaccine, and it can be as high as 30 times what is required.”
Hooker said:
“More virus particles mean more problems. It means that you can have a cytokine storm. It means that you can have autoimmune reactions, and this has never ever been tested for safety.
“That’s a serious safety problem because we do not know what will happen without a maximum. There is no cap.”
Cytokine storm refers to “life-threatening systemic inflammatory syndromes involving elevated levels of circulating cytokines and immune-cell hyperactivation,” according to The New England Journal of Medicine. Hooker said this can lead to cellular damage and autoimmune disorders.
Hooker noted that higher concentrations of virus do not just mean a higher level of live virus, but also a higher concentration of “dead virus, RNA particles within the vaccine,” which can also lead to adverse reactions.
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Referring to Kessler’s deposition, Hooker said it “came to the conclusion that Merck concealed this information [and that] the packet insert was incorrect. It was nebulous and it did not reflect the higher concentration,” Hooker said. “He basically said Merck is deceiving the public.”
Kessler also testified that this practice continued at least until 2018. Hooker said, “Nothing has changed since 2018 that we know of … If Merck has done anything to change the formulation of the vaccine, it has not told the public, it has not told the FDA.”
This means the practice of “overfilling” might still continue today.
“We’re in no-man’s land,” Hooker said. “We do not know how this is going to affect the body because this has never been tested at this concentration. This was a brand experiment that they foisted on the public of the United States.”
Merck ‘defrauded’ the government and the public
Hooker said the revelations stemming from the whistleblower lawsuit show the FDA was initially unaware that Merck was “overfilling” the MMR II vaccine — calling into question the agency’s capability to perform oversight.
“The only way the FDA found out was when these court documents actually surfaced, because the only thing Merck directly told the FDA was the concentration of mumps virus [was] 160,000 virus particles,” Hooker said. “So, FDA had no idea that they’re going even higher.”
The lawsuit was filed under the False Claims Act — under which whistleblowers can be rewarded for disclosing fraud that results in a financial loss to the federal government.
It’s the same law under which a lawsuit alleging safety deficiencies during clinical trials for the Pfizer-BioNTech COVID-19 vaccine was filed.
The two whistleblowers in the Merck case — Stephen Krahling and Joan Wlochowski, virologists who worked for Merck in the early 2000s — have since become the subject of a recently released film, “Protocol 7,” which chronicles their claims.
According to Hooker, the revelations may lead to further legal implications for the company and may call into question the liability shield it enjoys for its MMR II vaccine.
“Merck not only defrauded the government … Merck defrauded the public,” Hooker said. “From my contention, that would be a very, very good legal argument to opt out of the National Vaccine Injury Compensation Program [because] it is a no-fault program, and it assumes that the vaccine manufacturers acted in good faith.”
Hooker said this “really means that this could be taken to court by … individual petitioners” because Merck was “duplicitous and they have not been forthcoming with the exact concentrations that are in those vials.”
“This is fraud, pure and simple,” Hooker said.
Merck ‘not an entity that we should trust to put things into our bodies’
According to Hooker, the allegations against Merck are indicative of broader corruption among public health agencies and pharmaceutical companies — including a “revolving door” between the two.
Hooker said Merck “is the company that brought us Vioxx, that basically knew that this was going to cause cardiac damage … in individuals that took Vioxx.”
Merck also faces hundreds of lawsuits relating to injuries and deaths connected to Gardasil, its human papillomavirus (HPV) vaccine.
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“The first version of Gardasil … that came out in 2007 was then very quickly put on the CDC [Centers for Disease Control and Prevention] schedule,” Hooker said. “And then the CDC director [Dr. Julie Gerberding] … left the CDC in 2008 and started as the president of Merck’s vaccine manufacturing division … in 2009.”
“There’s a revolving door there, and I think that if we really were able to open the coffers in terms of the relationship with Merck and Gerberding while she was at the CDC, we would show that they did quite a few favors,” Hooker added.
“When you look at chief officials at the FDA, in the CDC and in the HHS [U.S. Department of Health and Human Services] … there’s so many conflicts of interest — and the conflicts of interest run not only at the top level, but they get down into the woodwork of the individual workers and scientists,” Hooker said.
Noting that Merck has had an “exclusive license” to distribute MMR vaccines in the U.S. “for many, many years,” Hooker said that this is likely why the company sought to quietly change the concentration of live mumps virus in its vaccine, “even if it meant fudging the books,” to maintain its market exclusivity.
“When you look at Vioxx, when you look at HPV, when you look at the … MMR II vaccine, this is not an entity that we should trust to put things into our bodies,” Hooker said, referring to Merck, adding that agencies like the FDA “are not trustworthy.”
“They are driven very, very much by financial gain directly through incentivization, through the pharmaceutical industry,” Hooker said.
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Five Things New “Preppers” Forget When Getting Ready for Bad Times Ahead
The preparedness community is growing faster than it has in decades. Even during peak times such as Y2K, the economic downturn of 2008, and Covid, the vast majority of Americans made sure they had plenty of toilet paper but didn’t really stockpile anything else.
Things have changed. There’s a growing anxiety in this presidential election year that has prompted more Americans to get prepared for crazy events in the future. Some of it is being driven by fearmongers, but there are valid concerns with the economy, food supply, pharmaceuticals, the energy grid, and mass rioting that have pushed average Americans into “prepper” mode.
There are degrees of preparedness. One does not have to be a full-blown “doomsday prepper” living off-grid in a secure Montana bunker in order to be ahead of the curve. In many ways, preparedness isn’t about being able to perfectly handle every conceivable situation. It’s about being less dependent on government for as long as possible. Those who have proper “preps” will not be waiting for FEMA to distribute emergency supplies to the desperate masses.
Below are five things people new to preparedness (and sometimes even those with experience) often forget as they get ready. All five are common sense notions that do not rely on doomsday in order to be useful. It may be nice to own a tank during the apocalypse but there’s not much you can do with it until things get really crazy. The recommendations below can have places in the lives of average Americans whether doomsday comes or not.
Note: The information provided by this publication or any related communications is for informational purposes only and should not be considered as financial advice. We do not provide personalized investment, financial, or legal advice.
Secured Wealth
Whether in the bank or held in a retirement account, most Americans feel that their life’s savings is relatively secure. At least they did until the last couple of years when de-banking, geopolitical turmoil, and the threat of Central Bank Digital Currencies reared their ugly heads.
It behooves Americans to diversify their holdings. If there’s a triggering event or series of events that cripple the financial systems or devalue the U.S. Dollar, wealth can evaporate quickly. To hedge against potential turmoil, many Americans are looking in two directions: Crypto and physical precious metals.
There are huge advantages to cryptocurrencies, but there are also inherent risks because “virtual” money can become challenging to spend. Add in the push by central banks and governments to regulate or even replace cryptocurrencies with their own versions they control and the risks amplify. There’s nothing wrong with cryptocurrencies today but things can change rapidly.
As for physical precious metals, many Americans pay cash to keep plenty on hand in their safe. Rolling over or transferring retirement accounts into self-directed IRAs is also a popular option, but there are caveats. It can often take weeks or even months to get the gold and silver shipped if the owner chooses to close their account. This is why Genesis Gold Group stands out. Their relationship with the depositories allows for rapid closure and shipping, often in less than 10 days from the time the account holder makes their move. This can come in handy if things appear to be heading south.
Lots of Potable Water
One of the biggest shocks that hit new preppers is understanding how much potable water they need in order to survive. Experts claim one gallon of water per person per day is necessary. Even the most conservative estimates put it at over half-a-gallon. That means that for a family of four, they’ll need around 120 gallons of water to survive for a month if the taps turn off and the stores empty out.
Being near a fresh water source, whether it’s a river, lake, or well, is a best practice among experienced preppers. It’s necessary to have a water filter as well, even if the taps are still working. Many refuse to drink tap water even when there is no emergency. Berkey was our previous favorite but they’re under attack from regulators so the Alexapure systems are solid replacements.
For those in the city or away from fresh water sources, storage is the best option. This can be challenging because proper water storage containers take up a lot of room and are difficult to move if the need arises. For “bug in” situations, having a larger container that stores hundreds or even thousands of gallons is better than stacking 1-5 gallon containers. Unfortunately, they won’t be easily transportable and they can cost a lot to install.
Water is critical. If chaos erupts and water infrastructure is compromised, having a large backup supply can be lifesaving.
Pharmaceuticals and Medical Supplies
There are multiple threats specific to the medical supply chain. With Chinese and Indian imports accounting for over 90% of pharmaceutical ingredients in the United States, deteriorating relations could make it impossible to get the medicines and antibiotics many of us need.
Stocking up many prescription medications can be hard. Doctors generally do not like to prescribe large batches of drugs even if they are shelf-stable for extended periods of time. It is a best practice to ask your doctor if they can prescribe a larger amount. Today, some are sympathetic to concerns about pharmacies running out or becoming inaccessible. Tell them your concerns. It’s worth a shot. The worst they can do is say no.
If your doctor is unwilling to help you stock up on medicines, then Jase Medical is a good alternative. Through telehealth, they can prescribe daily meds or antibiotics that are shipped to your door. As proponents of medical freedom, they empathize with those who want to have enough medical supplies on hand in case things go wrong.
Energy Sources
The vast majority of Americans are locked into the grid. This has proven to be a massive liability when the grid goes down. Unfortunately, there are no inexpensive remedies.
Those living off-grid had to either spend a lot of money or effort (or both) to get their alternative energy sources like solar set up. For those who do not want to go so far, it’s still a best practice to have backup power sources. Diesel generators and portable solar panels are the two most popular, and while they’re not inexpensive they are not out of reach of most Americans who are concerned about being without power for extended periods of time.
Natural gas is another necessity for many, but that’s far more challenging to replace. Having alternatives for heating and cooking that can be powered if gas and electric grids go down is important. Have a backup for items that require power such as manual can openers. If you’re stuck eating canned foods for a while and all you have is an electric opener, you’ll have problems.
Don’t Forget the Protein
When most think about “prepping,” they think about their food supply. More Americans are turning to gardening and homesteading as ways to produce their own food. Others are working with local farmers and ranchers to purchase directly from the sources. This is a good idea whether doomsday comes or not, but it’s particularly important if the food supply chain is broken.
Most grocery stores have about one to two weeks worth of food, as do most American households. Grocers rely heavily on truckers to receive their ongoing shipments. In a crisis, the current process can fail. It behooves Americans for multiple reasons to localize their food purchases as much as possible.
Long-term storage is another popular option. Canned foods, MREs, and freeze dried meals are selling out quickly even as prices rise. But one component that is conspicuously absent in shelf-stable food is high-quality protein. Most survival food companies offer low quality “protein buckets” or cans of meat, but they are often barely edible.
Prepper All-Naturals offers premium cuts of steak that have been cooked sous vide and freeze dried to give them a 25-year shelf life. They offer Ribeye, NY Strip, and Tenderloin among others.
Having buckets of beans and rice is a good start, but keeping a solid supply of high-quality protein isn’t just healthier. It can help a family maintain normalcy through crises.
Prepare Without Fear
With all the challenges we face as Americans today, it can be emotionally draining. Citizens are scared and there’s nothing irrational about their concerns. Being prepared and making lifestyle changes to secure necessities can go a long way toward overcoming the fears that plague us. We should hope and pray for the best but prepare for the worst. And if the worst does come, then knowing we did what we could to be ready for it will help us face those challenges with confidence.
