Convincing Pregnant Women to Avoid Using Acetaminophen

The agency’s head cited the well-known but rarely deployed concept to convince pregnant women to avoid using acetaminophen. Why not do the same for global warming and PFAS chemicals? Merrill Goozner’s (GoozNews) discussion points opposing Kennedy and Trump’s opposition to using Tylenol when pregnant. It is becoming stranger in the US with Trump’s failing awareness and with Kennedy who defies description.

“Trump’s FDA puts the precautionary principle in play,” GoozNews

Yesterday, Donald Trump and the officials he installed at the Food and Drug Administration abandoned the agency’s long-standing rules for making decisions about the safety and efficacy of drugs, medical devices and the other products it regulates.

In their place, its top officials, with the president leading the charge, made a decision by diktat, ignoring the preponderance of scientific evidence to warn people not to use a medical product they find personally objectionable. Yesterday’s controversial decision to warn pregnant women to avoid using acetaminophen (Tylenol) during pregnancy because it may cause autism was made without review by agency scientists, without a public hearing, and without advice from outside experts, most of whom disagree with their decision.

An agency once considered a beacon for scientific reasoning today looks more like tarnished brass, not the gold standard for international medical product regulation it once was.

As Stat reporter Matthew Herper pointed out in his article about this decision: “Most researchers who have looked at the question of whether Tylenol taken during pregnancy is tied to autism do not claim the evidence shows that there is a relationship between the two, and some prominent researchers now think the common painkiller is unlikely to play a role.”

One recent analysis of 46 studies, published in the journal Environmental Health, admitted the data was inconclusive, but ended by saying it was worth warning women about the risk. Its main author, Andrea Baccarelli, dean of the faculty at Harvard T.H. Chan School of Public Health, has served as an expert witness for plaintiffs in lawsuits against Kenvue Inc. (formerly part of Johnson & Johnson), the over-the-counter drug’s manufacturer.

More than 500 lawsuits have been filed against Kenvue alleging a tie between acetaminophen and autism. Most have been dismissed in court. The Wall Street Journal reported this morning that plaintiff appeals will now “likely include the Trump administration’s warning in their argument to the appellate court that the lower-court dismissals should be” set aside.

Baccarelli’s study represents the type of conflict of interest that HHS Secretary Robert F. Kennedy Jr. frequently rails against, like when he dismisses evidence there is no connection between the MMR (measles, mumps and rubella) vaccine and autism.

The U.S. has now become an outlier nation when it comes to drug regulation. United Kingdom’s Medication and Healthcare products Regulatory Agency on Monday reiterated its conclusion that acetaminophen is safe when used as directed. Alternatives like aspirin and ibuprofen pose well-characterized risks (including miscarriages in the former and fetal kidney damage in the latter). “Untreated pain and fever can pose risks to the unborn baby, so it is important to manage these symptoms with the recommended treatment,” the British agency said.

FDA Commission Marty Makary’s offered contradictory statements to physicians and the public yesterday. His letter to physicians reflected the reality that the link between acetaminophen and autism has not been established and the over-the-counter drug is probably the safest analgesic to use when pregnant women become sick with a high fever, which poses serious risks to the developing fetus. Here’s a lengthy excerpt from the letter:

To be clear, while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature. The association is an ongoing area of scientific debate and clinicians should be aware of the issue in their clinical decision-making, especially given that most short-term fevers in pregnant women and young children do not require medication. In the spirit of patient safety and prudent medicine, clinicians should consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers. This consideration should also be balanced with the fact that acetaminophen is the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics; aspirin and ibuprofen have well-documented adverse impacts on the fetus.

Yet in public, standing behind the president, he toed the administration line. Here’s his statement in the HHS press release:

“The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen. Even with this body of evidence, the choice still belongs with parents. The precautionary principle (emphasis added) may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment.”

The precautionary principle

I have never heard the precautionary principle invoked by an FDA official before. The principle is in conflict with the agency’s legislated mandate that manufacturers scientifically prove a medical product is safe and effective before their products are allowed on the market. The agency must also provide scientific evidence that a product is unsafe or ineffective before it can be removed from the market.

Since many medical products have unwanted side effects, the agency is required to balance those risks against the benefits when making its decisions. When the benefits outweigh the risks, the labels must warn physicians and consumers about those risks, but it doesn’t keep them from being prescribed and sold. It has never written a label that says in effect you had better think twice before using this product.

To the regret of a great many physicians and consumer advocates, the FDA has never been given the authority to evaluate the relative risks and rewards of different treatments for the same condition. Drug A may have fewer risks than Drug B. Drug A may also have greater impact on the disease than Drug B. But both can be approved as safe and effective as long as the risks of each are outweighed by the rewards of each when evaluated independently.

If the precautionary principle was routinely used by the FDA when making its decisions, agency scientists would be evaluating the relative risks and rewards of all drugs that treat a particular medical condition when a new drug for that condition comes along. In the above hypothetical example, if Drug A came along after Drug B, it would be approved, and Drug B would either be pulled from the market or given a black box warning that tells consumers and physicians it is worse than other drugs in its class.

In other words, the precautionary principle embodies the common sense concept that it is better to be safe than sorry. That’s why Makary, after invoking the principle to warn against use of acetaminophen during pregnancy, added in his public statement that “it remains reasonable for pregnant women to use acetaminophen in certain scenarios.” Even he and his bosses (Kennedy and Trump) had to admit that that risk of autism is much smaller than the serious risks to the fetus from leaving a high fever during pregnancy untreated.

The precautionary principle, while never before invoked in FDA decision-making, comes up routinely raised by environmental groups during regulatory proceedings. It is routinely ignored by EPA regulators in favor of corporate interests.

For instance, global warming presents a clear and present danger to the health, wealth and well-being of the entire planet. The science is clear. Temperatures are rising. Glaciers are melting. Sea levels are rising. Species are dying.

If applied, the precautionary principle dictates that governments and regulators take immediate steps to curb these proven outcomes by preventing more carbon from being poured into the atmosphere. Alternative technologies to carbon-based fuels like wind, solar, hydro and nuclear power are not only cheaper (and thus more cost-effective), they pose far fewer environmental risks.

Or, take the mounting evidence that “forever chemicals” (per- and polyfluoroalkyl substances or PFAS) used in a wide range of products (water- and stain-resistant fabrics, non-stick pans, firefighting foam) are accumulating in the environment and causing myriad health problems. They include increased risk of various cancers, infertility, developmental delays in children, and decreased immune response to infectious diseases.

Don’t these mounting health risks outweigh the minor benefits of consumer convenience? The precautionary principle invoked by Makary at the FDA yesterday, if applied by the EPA, would require the chemical industry immediately begin a search for substitutes for PFAS and establish a deadline for ending their further accumulation in the environment.

Environmentalists lost the debate over the precautionary principle decades ago when industry lobbyists successfully prevented its use during EPA regulatory proceedings. Its burial became a bipartisan affair when University of Chicago economist Cass Sunstein became the regulatory czar under President Barack Obama. His 2005 book, “Laws of Fear: Beyond the Precautionary Principle,” argued deployment of the precautionary principle in the face of uncertain environmental risks retarded innovation. He endorsed cost-benefit analysis as a substitute.

Today, given mounting environment risks whose ultimate cost is incalculable, it is time to revisit that debate. Trump and Makary have provided the opening by their hypocritical use of the precautionary principle to bypass time-proven regulatory standards at the FDA.