The U.S. Food and Drug Administration (FDA) has been sued for withholding the results of key COVID-19 vaccine safety analyses.
The FDA’s actions violate federal law, the new lawsuit, filed on Jan. 26 in federal court in Washington by the nonprofit Children’s Health Defense (CHD), alleges.
The suit is seeking the raw results from the FDA’s analyses of reports to the Vaccine Adverse Event Reporting System (VAERS).
The system, which the FDA runs with the U.S. Centers for Disease Control and Prevention, accepts reports of post-vaccination adverse events.
As part of its vaccine safety monitoring, the FDA pledged to run a type of analyses called Empirical Bayesian (EB) data mining on the reports to see if any safety signals were triggered. Signals give agencies an idea of which problems may be caused by vaccines. Agencies are supposed to research signals to verify them or rule them unrelated to vaccination.
“A report to VAERS does not mean that a vaccine caused an adverse event. But VAERS can give CDC and FDA important information. If it looks as though a vaccine might be causing a problem, FDA and CDC will investigate further and take action if needed,” the CDC says on its website.
The FDA denied CHD’s request for the results of the data mining, claiming the records are “intra-agency memoranda consisting of opinions, recommendations, and policy discussions within the deliberative process of FDA, from which factual information is not reasonably segregable.”
The FDA also claimed the sought-after information “contains a discussion of legal and policy matters and fall within the attorney work product and attorney-client privileges as enunciated by the Supreme Court.”
The FDA also refused to provide the results of the EB data mining to The Epoch Times, using the same rationale.
In a set of operating procedures, the federal government said the FDA would carry out Empirical Bayesian data mining and the CDC would conduct a separate type of analyses using a method called Proportional Rate Ratio, or another way to analyze the VAERS data.
After lying about when it started the proportional data mining and stonewalling inquiries, the CDC recently released the results of the analyses to The Epoch Times, revealing the agency identified hundreds of adverse events potentially connected to the Pfizer and Moderna COVID-19 vaccines.
Kim Witczak, co-founder of Woodymatters, a nonprofit that advocates for a stronger FDA and drug safety system, said at the time that the agency’s refusal to provide the analyses was not acceptable.
“The secrecy is unacceptable for an agency that said it is transparent with the public about vaccine safety,” Witczak said.
Lawmakers, including Rep. Ronny Jackson (R-Texas), have also questioned (pdf) why the records were not released.
The FDA and CDC only publicly acknowledge a small number of adverse events as being definitely caused by or potentially caused by the messenger RNA shots, including myocarditis, or heart inflammation.
The CDC claimed that the results of its analyses “were generally consistent with EB data mining.”
CHD says the refusal by the FDA to release the EB mining results violates the Freedom of Information Act, which enables people and organizations to request information from federal agencies.
While exemptions exist, the FDA improperly withheld the requested data, the new lawsuit charges. It notes that the FDA did not provide any evidence to support its claims that it could not release the records.
While the CHD appealed to the government for a fresh look at the request, the FDA said it would not have a response to the appeal until “around” the summer of 2023.
The Freedom of Information Act requires an agency to make requested records “promptly available” to a requester and imposes other time restrictions, which have not been adhered to, the suit says.
CHD is asking the court to find the FDA’s failures to meet the time requirements unlawful and order the FDA to produce all non-exempt records within 20 days. CHD is also asking the court to award attorneys’ fees and other litigation costs. The FDA did not respond to a request for comment.
“It is long overdue for the FDA to release the data on the Empirical Bayesian data mining that it promised even before the COVID shot rollout” Mary Holland, president and general counsel of CHD, said in a statement. “It is reprehensible for this agency, established to protect the American people, to conceal critical data. I trust that the courts will command the FDA to do its job.”
Article cross-posted from our premium news partners at The Epoch Times. Image by Felton Davis via Flickr, CC BY 2.0.
Why Bullion Beats Numismatics and Collectible for Your Safe or IRA
Precious metals continue to attract Americans seeking reliable ways to protect their wealth amid inflation, geopolitical risks, and stock market swings. Whether stored in a home safe or held inside a self-directed IRA, physical gold and silver deliver tangible value that paper or digital assets often lack. Yet investors must choose carefully between bullion—pure bars and coins valued mainly for their metal content—and numismatics or collectibles, where rarity, history, and collector demand heavily influence pricing.
Advisor Bullion serves as a dependable source for straightforward, high-quality bullion. The company specializes in physical gold, silver, platinum, and palladium, emphasizing transparent pricing and products that deliver maximum metal content for every dollar spent. This approach makes it ideal for both personal holdings and retirement accounts.
Bullion consists of refined precious metals in standard forms like one-ounce coins (American Gold Eagles, Silver Eagles, Canadian Maple Leafs) or bars. Their value tracks closely to the current spot price of the metal. A typical gold bullion coin trades near the live gold spot price plus a small premium. This structure keeps costs clear and predictable.
Numismatic coins and collectibles add substantial value from factors such as age, rarity, minting errors, or historical significance. A pre-1933 U.S. gold coin or graded proof piece can carry premiums of 30%, 50%, or even 200% above melt value. While this appeals to hobbyists, it creates complexity. Pricing depends on subjective grading, collector trends, and auction results instead of daily spot prices.
For investors focused on wealth preservation and retirement security rather than building a collection, bullion often delivers better results.
Lower Costs and Better Liquidity for Home Storage
When keeping metals in a home safe or private vault, liquidity and efficiency count. Bullion offers clear benefits:
- You acquire more actual gold or silver per dollar invested. Numismatics divert a large share of your money into rarity premiums and massive sales commission, reducing your metal exposure.
- Selling bullion involves tight bid-ask spreads, so you recover nearly full spot value with minimal fees. Collectibles require finding the right buyer and may sell at a discount if demand for that specific item weakens.
- Bullion prices remain transparent and update with global spot markets. You can track gold near current levels or silver accordingly and know exactly where your holdings stand. Numismatic values are priced by the Gold IRA companies with hefty margins applied.
- Standardized coins and bars store efficiently and divide easily for partial sales. Rare coins often need protective slabs and controlled conditions, adding hassle and expense.
- Bullion enjoys worldwide acceptance. A 1-oz Gold Maple Leaf or Silver Eagle sells quickly to dealers anywhere. Niche numismatic pieces may appeal only to limited buyers, slowing liquidation when speed matters.
In times when quick access to value becomes important, bullion’s simplicity stands out.
Stronger Fit for Precious Metals IRAs
Precious metals IRAs continue gaining traction as investors diversify retirement portfolios beyond stocks and bonds. IRS rules permit certain bullion products in self-directed IRAs if they meet purity standards (.995 fine for gold, .999 for silver) and are held by an approved custodian. Eligible items include American Gold and Silver Eagles plus many generic bars and rounds from recognized mints.
Numismatic and most collectible coins generally face heavy scrutiny from custodians due to valuation disputes and elevated markups. These higher premiums mean less actual metal ends up working inside the account.
Bullion avoids these issues. Its value links directly to verifiable spot prices, which simplifies reporting and lowers the risk of regulatory challenges. More of your IRA contribution purchases real metal instead of dealer profits or speculative upside. Over time, owning additional ounces that appreciate with the metal itself can create meaningful outperformance compared with high-premium alternatives that deliver fewer ounces.
Regulatory guidance from the CFTC and state securities offices repeatedly cautions against aggressive sales of expensive numismatics or “semi-numismatic” coins for IRAs. For retirement planning, transparent bullion from established providers reduces risk and aligns better with long-term goals.
How to Get Started with Bullion
Begin by clarifying your goals. Are you protecting savings in a safe, or moving part of a retirement account into a precious metals IRA? Focus on the number of ounces you can acquire at current prices rather than chasing marked-up collectibles.
Diversify sensibly: use gold for core preservation and silver for its blend of industrial and monetary qualities. Mix coins for easier divisibility with bars for lower per-ounce costs on larger buys. Arrange secure storage—whether at home with proper insurance or through professional facilities.
As economic uncertainties linger and faith in conventional assets erodes, bullion continues proving its worth as a dependable store of value. Its direct approach avoids the hype that sometimes surrounds collectible markets and keeps the focus on the metal itself.
For investors prepared to strengthen their portfolios, Advisor Bullion supplies the expertise and selection needed to acquire high-quality bullion efficiently. Whether building personal holdings or integrating metals into an IRA, their emphasis on transparent, investment-grade products helps secure more ounces today that support greater financial security tomorrow. In a complicated financial landscape, bullion’s clarity and reliability make it the smarter foundation for protecting what matters most.
The Courts Will Command the FDA to Do Its Job?????
That would be a good idea.
But not right away. The courts usually get it right, but not in the time it matters to the litigants.
Not much you can do to force the FDA to do their job – they are a law unto themselves and will do what they dam well please.
Fire about half of them or more is the real remedy. And if that doesn’t work, fire another half. Rinse and repeat until they can do no harm.
Courts in a banana republic don’t consider the law or constitution in making their rulings. There is no arguing that the USA is 100% banana republic (since 2008.)
The FDA and CDC both violated the law by changing the definition of “vaccine” as stated in USC 26 §4132 (a)(2). THEY DO NOT HAVE THE AUTHORITY TO CHANGE THE DEFINITION ONLY THE LEGISLATURE DOES. USC 26 states that a vaccine is defined as a “substance that prevents one or more diseases”.
NONE of the paperwork for ANY OF THE Candidate shots meets that level in their description. They only say “may reduce the symptoms”. FDA and CDC are guilty of FRAUD and “Crimes against Humanity” and should be held accountable.