Americans from all political backgrounds want more transparency in FDA drug approval decisions
According to a new study, Americans of all political persuasions, genders, races and levels of education want medical regulators to be more transparent.
Researchers from Johns Hopkins University in Baltimore, Maryland asked Americans whether they agree with certain statements about the Food and Drug Administration (FDA) and the transparency of some of its decisions.
Of the ten statements presented to participants, all received support of 65% or more.
The researchers also found little difference in participants’ responses based on demographic factors such as education or political leanings.
In an era of heightened political polarization in the United States, it is rare for Americans to agree with each other across the aisle.
However, there seems to be universal recognition of the need for greater transparency on the part of the FDA.
“The idea behind the project was that at a time when the FDA’s public profile was probably higher than [any other time] in everyone’s living memory, is there a reason why the agency should communicate more clearly, and are there opportunities to do so,’ said Dr. Tej Azad, neurosurgery resident at Johns Hopkins and lead author of the study to DailyMail. com.
Azad and the team, who published their findings last week in Open JAMA Networkcollected data from 4,002 participants for the study.
The study population was asked about ten statements regarding FDA transparency and rated each on a five-point scale ranging from “strongly agree” to “strongly disagree.”
Dr Tej Azad (pictured), neurology resident at Johns Hopkins University, said the decision-making ‘pendulum’ between experts and average people should swing back to the middle
Questions include whether the FDA should provide more information about drug decisions, when drug trials are halted or suspended, and more explanations about actions and decisions made by federal regulators.
All ten statements had significantly higher levels of participants’ approval than disapproval.
The most endorsed statement was: “If pharmaceutical companies provide false or misleading drug development information to the public, the FDA should share the correct information with the public”, with 90% of participants in favour, with only 0 .6% showing opposition.
A single statement elicited more than 11% opposition: “The FDA should share with the public the agency’s analyzes of drugs that pharmaceutical companies have stopped developing.
There was at least a 50 point margin between support and opposition for each of the ten statements.
The researchers also broke down the data by race, education level, household income, geographic region, political party identification and even who a person voted for in the 2020 presidential election.
Overall, Americans wanted transparency from regulators. Azad described it as a surprise, noting that Americans don’t seem to agree on much anymore.
Government calls for transparency are not new ideas, however, and citizens are expected to want their tax-funded organizations to respond to them.
There are, however, potential downsides to expanded access to information. Much misinformation spread about COVID-19, for example, comes from misinterpreted authentic sources – whether maliciously or not.
The researchers found that across all demographics, Americans want the FDA to be more transparent. A senior researcher says experts need to properly convey information to ordinary people without being ‘paternalistic’ (File photo)
Ivermectin has become a household name in recent months for this very reason. The anti-parasitic drug has gained prominence in some conservative and anti-vaccine circles as a potential cure for Covid.
The source of these claims is a legitimate, peer-reviewed Australian study that showed the drug could inhibit virus replication in a lab environment.
The doses used in the study are so concentrated that they would not be safe for human use, and the results are only reproducible inside a laboratory and not in human subjects.
There have been several studies of ivermectin in the treatment of Covid patients since the drug’s rise to prominence and each has shown that it lacks the ability to fight the virus in humans.
Azad says it’s the responsibility of health experts to properly communicate information in a way that doesn’t seem ‘paternalistic’ and to ensure that people are given enough information to enable them to make the right decision for themselves. themselves.
“We think a lot about paternalism,” he said.
“Where you come out in the balance between trying to get people to adopt what you really think is the right thing or the right behavior, versus really stepping back and [saying] “hey, here’s all the information you’re making the call.”
“I think the reality is that for something like that, the right answer is somewhere in between.”
Americans misinterpreting an ivermectin study led many to mistakenly believe the anti-parasitic drug could treat COVID-19 symptoms, a potential mark against better access to information (file photo)
Biogen’s Aduhelm was denied Medicare funding and the FDA was widely criticized after approving the drug despite two failed clinical trials, in what could be seen as a positive result of greater transparency ( archive photo)
He describes the situation as a pendulum currently swinging in the direction of the experts, leaving many average people feeling left out of key medical decisions. The pendulum should be more towards the middle, says Azad.
A contrary example to ivermectin is what happened after the Alzheimer’s drug Aduhelm received FDA approval last summer.
The drug still managed to receive the green light from the FDA despite two failed clinical trials and limited data showing it was effective.
A flurry of neurological experts pored over the data for themselves and slammed the FDA’s decision.
An intense backlash to the drug, fueled by those experts with access to the trial date, led to the drug being rejected for reimbursement by Medicare and former acting FDA director Janet Woodcock even calling for an investigation into its own agency for approving the drug.
In this case, transparency and easy access to information may have corrected a mistake made by regulators, Azad believes.
Ten statements presented to study participants
- The FDA should share with the public the reasons why the drugs are not improved
- FDA should share company and drug name with public when companies seek to conduct human subject studies
- The FDA should notify the public when studies are suspended and the reasons for suspending a study
- If the FDA allows a suspended study to restart, the FDA must share with the public the reasons why the study resumed
- FDA should share company and drug name with public when generic drug applications are filled
- The FDA should share with the public when the agency is expediting a review as well as the scientific basis for that action
- The FDA should share with the public how the special safety measures put in place for certain drugs work
- The FDA should publish a list of drugs that drug companies have stopped developing
- The FDA should share with the public the agency’s analyzes of the drugs that pharmaceutical companies have stopped developing
- If pharmaceutical companies provide false or misleading drug development information to the public, the FDA must share the correct information with the public.