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In 2016, Congress passed a law that was meant to get life-saving drugs into the hands of those who need them more quickly.
The 21st Century Cures Act enabled the FDA to approve drugs for things like cancer within weeks or months, instead of years.
But the Act also made the approval process more lenient.
And opened the door for the FDA to provide less and less information about exactly how these new drugs are being tested and approved.
Now, researchers are starting to question the wisdom of the Act.
Are we really still “informed consumers” when it comes to the drugs we take? Or are we — and the people we rely on to help us make decisions about matters of health and medicine, like our physicians — being kept in the dark?
The drug approval process is less strict
Studies by Oregon State University researchers point to two problems that have arisen since the Cures Act was passed:
- Standards for FDA approval of new drugs have been relaxed
- Less information is being shared with the public about the approval process
For example, of the 37 drugs approved by the FDA in 2022, 24 (about 65%) were approved based on a single study. In 2016, prior to the Cures Act, only four of 20 new drugs (20%) were approved based on a single trial.
Sometimes, to speed up the process, surrogate markers were used in place of an actual clinical trial of the drug.
In simple terms, surrogate markers are “stand-ins” for the real thing. They are characteristics that get measured as indicators of health, disease or a particular condition.
For example, it might take years of following patients in a long-term clinical trial to determine if a drug reduces their risk of a heart attack.
Measuring the surrogate marker of blood pressure enables the drug to move through the approval process more quickly.
But the problem, says Dr. Veronica Irvin, a study co-author, is that reduced blood pressure is not a guarantee of reduced risk of death from heart disease. Again, it’s a stand-in for the real thing.
We’re getting less and less information
The other problem is that, under the Act, drug companies aren’t required to give us as much information about how their drugs get approved.
While many drugs have been tested in multiple clinical trials, pharmaceutical companies are only required to share the results from two of those trials.
Dr. Irvin says that this raises questions about why a drug company chose two particular trials for submission. What about the rest of the trials? How did they work out?
In 2017, drugmakers completed an average of 5.82 studies per drug before FDA approval. But on ClinicalTrials.gov, the place for consumers to read this kind of information, only 1.42 studies per drug were reported.
“We want doctors and patients to be able to see the whole picture,” she adds.
Consumers and caregivers beware
Dr. Irvin and her fellow researchers have raised questions not only of transparency but of honesty.
“Despite efforts by the FDA to increase transparency,” they say, “investigators are still able to selectively report outcomes for variables that favor treatment effectiveness.”
It’s not uncommon, they found, for results to be reported right after a drug is approved. Were these companies withholding results that reflected badly on their product, and only releasing results that showed their product in the best light?
Among the drugs approved by the FDA between 2017 and 2020, five had been refused approval by FDA peer agencies in other countries.
Health technology agencies in Australia, Canada, and the United Kingdom declined to endorse 42 drugs because the benefits were “uncertain” or the costs were excessive.
If pharmaceutical companies are not publishing all their results to the public on ClinicalTrials.gov, there’s little that can be done to make them.
But it’s wise to be aware of these things and to have discussions with your doctor or pharmacist regarding your choice of medication.
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21st Century Cures Act — FDA.gov