The Wink-and-Nudge Culture of Drug Surveillance

Commentary

When the Food and Drug Administration (FDA) approves a pharmaceutical product, it often comes with a stipulation. The producing company must provide complete safety reports once the drug comes into use. This is called after-market surveillance.

It is a mandate often invoked to put fears to rest on the part of people who worry that many drugs on the market are unsafe. The FDA, we are told, is the cop on the beat. The companies have to report back to the government and prove that the drug is safe.

And yet there is a problem, according to a new report out from the Washington Post. Citing an examination of FDA records, the report found “hundreds of postmarket studies listed as delayed.”

In some cases, “the work was delayed by more than a decade, or the manufacturer was still developing a plan for the study. As a result of delays, patients, doctors and others could be left in a fog about the risks and benefits of the drugs or devices, even as they stake their money, their health or their lives on the products.”

How bad is it?

“The database showed almost 600 were running behind schedule. Of those, more than 250 originally had final reports due before July 31, 2026—the date that, according to an FDA webpage, the database last had been updated. About a third of ongoing studies were listed as delayed.”

Meanwhile—and this is undoubtedly a crucial reason for why the reports are delayed—the companies can make all the money they can from sales. They simply are not stopped. There is no trigger in place that is ever enforced.

There is an obvious pattern at work. If the news is good, the report comes out. If the news is bad, the report is delayed for as long as possible. This is the “dog-ate-my-homework” method of avoiding accountability.

One of these delayed reports involves Paxlovid as made by Pfizer for a 5-day course that costs $2,000. Anthony Fauci and many other public health authorities promoted its use throughout the pandemic, despite reports that it frequently led to rebound cases. It is also a very expensive drug. Its postmarketing surveillance report has not been filed.

The trial completion and final report milestones were missed, the database revealed. Pfizer remains committed to “submitting results as soon as practicable,” Pfizer spokesperson Jerica Pitts told the paper.

Apparently this problem is well known by those who follow this sector closely. Last year, I pointed out to a friend that Moderna faced strict post-marketing surveillance standards in its pending approval of a new flu shot. Perhaps, then, we should not worry. My friend pointed out to me that they always say this but it rarely happens if there is bad news to report.

In other words, this is a time-tested scheme to calm the public but the standards are not enforced by the FDA. The FDA says it lacks real enforcement power because Congress has never given it to them. Their mandate turns out to be more of a recommendation.

This is a long pattern first documented in a 2009 study by the Government Accounting Office. The study, then commissioned by journalist Paul Thacker, found “weaknesses in FDA’s monitoring and enforcement process hamper its ability to effectively oversee postmarketing studies. FDA has not routinely been reviewing sponsors’ annual submissions on the status of studies in a timely manner.”

It’s just not a priority for the agency. “It has never exercised its authority, even when such study requirements have gone unfulfilled for nearly 13 years.”

This is another way of saying that the requirements are completely toothless. This is no small matter. We are talking here about the biological safety of the public.

Returning to basics, the entire point of the FDA is to be the cop on the beat to assure the effectiveness and safety of drugs it approves for the American people to use. All pharmaceutical products come with risks, of course, but in order to assess tradeoffs, we need to know what those risks are.

Even if companies don’t seem to bother much with this surveillance that they are supposedly required to do, surely the public health agencies have monitoring systems that flag signals. Right? Well, there is a problem there too. You will need to sit down for this one but here goes.

The British Medical Journal (BMJ) has reported that the reason agencies never reported high injuries from mRNA COVID shots is that their own surveillance systems did not flag them. The reason is astonishing: there were so many and they were equally divided between Pfizer and Moderna. The statistical models are designed to detect signals in single products when they veer too far from other products on the surveillance systems. These injury reports moved together so they disappeared.

“U.S. officials embraced an algorithm for detecting signals of harm from mRNA COVID-19 vaccines,” the BMJ reports, “that they knew was broken and suppressed efforts to fix it.”

It gets weirder. The editor of the prestigious academic journal Vaccines, Gregory Poland, who also headed research at the Mayo Clinic, developed severe ringing in his ears about an hour after his second COVID vaccination. That’s right: the editor of the journal on vaccines himself was injured by a shot.

Dr. Poland asked the CDC for information about other reported cases, while noting that he had received “a large number of emails regarding others with tinnitus post-mRNA vax.” The CDC told Poland that no signal had been found in VAERS to indicate linkage between the vaccines and tinnitus. Indeed, weekly FDA data-mining reports during this period show that the algorithm never signalled for myocarditis, pericarditis, or tinnitus.

Much of the work of the British Medical Journal here—notice that it was not published in a U.S. journal—was anticipated in explosive hearings and investigations by Senator Ron Johnson (R-Wis.). His report released April 29, 2026 found that:

“Dr. Ana Szarfman, who at the time was a senior medical officer and safety data mining developer at the Food and Drug Administration (‘FDA’), used an updated data analysis technique that identified dozens of statistically significant safety signals for adverse events associated with the COVID-19 vaccines. She immediately shared her findings with other FDA officials, including officials responsible for COVID-19 vaccine safety surveillance, but they largely ignored her and eventually told her to stop her data analyses.”

How many signals? She found 25 statistically significant safety signals hiding in plain sight. They hushed her up and continued to promote the products and eventually mandate them on pain of losing jobs and income.

Only The Epoch Times of all national media reported on the Senator’s investigation. The rest of the mainstream media ignored it. There was nothing the Senator could do to make big media outfits pay any attention at all.

As someone who never much thought about these issues before the pandemic, I find myself shocked and deeply alarmed that the safety part of “safe and effective” could be so completely neglected by the federal agency that is supposed to be policing the nation’s pharmaceutical products.

If we cannot count on the FDA to do its work, where can Americans go for trustworthy information? Only underfunded information sources and private networks fighting for a voice can guide us. And why is this not a scandal of a national and global scale?

Views expressed in this article are the opinions of the author and do not necessarily reflect the views of The Epoch Times.