The head of the U.S. Food and Drug Administration (FDA) has come under fire for failing to acknowledge the agency’s role in burying a non-addictive painkiller.
When asked during a Senate Appropriations subcommittee hearing on April 19 how he would tackle the opioid crisis, Commissioner Robert Califf stated, “It is a tough job, but we are not successful in having nonaddictive pain medicines coming through the pipeline. We need to do everything we can do to push industry and make this happen.”
There is such a drug, Toradol, and it should be in every medicine cabinet but is not, because of the FDA, says Charles L. Hooper, president of the health care consultancy Objective Insights and author of Should the FDA Reject Itself?
“Syntex [the developer] got Toradol approved by the FDA, but it had kind of a tortured path,” said Hooper on The Heartland Daily Podcast.
Toradol, the brand name for ketorolac, is a nonsteroidal anti-inflammatory drug that could provide morphine levels of pain relief without the same abuse potential as opioids. There is also an oral form of the drug.
‘A Forgotten Failure’
Hooper worked at Syntex when the FDA approved the injectable form of the drug in 1989. During the approval process, the company accepted the advice of an FDA employee who recommended it be administered with a “loading dose” at twice the nominal dosage. Gastrointestinal bleeding caused by the drug at high dosage killed 97 users between 1990 and 1993.
By the time the FDA modified the dosage instructions to eliminate the loading dose, the damage had been done.
Injectable Toradol IV/IM is still in use, especially as an emergency room treatment. Consumers prefer oral medications for home use, however, and although the FDA approved the oral version in 1991, FDA guidance effectively killed it.
“The drug reviewer, John Harter, had previously worked at Syntex and had been fired by the company,” said Hooper. “He came down hard on Toradol, putting three severe restrictions on the label, limiting dosage to 10 mg, adding a five-day limitation for dosage, and requiring users to start with an injection of Toradol IV/IM.
“So, you had to start off with a shot and then get a tablet that was one-sixth to [one]-third of the effective dose of 30 to 60 milligrams,” said Hooper. “Instead of Toradol oral being Syntex’s billion-dollar drug, it ended up being a forgotten failure.”
The rest is history, says Hooper.
“If a company came out with a 30-milligram version of Toradol oral, I have no doubt it would be one of the most widely used drugs in the country, but there’s no way I can see that they could make money from it,” said Hooper.
Toradol oral would be categorized as a new drug, so the FDA would require expensive clinical trials.
“The company would have a period of market exclusivity, but very quickly generic versions would come in and take market share,” said Hooper. “Also, for the FDA to approve it, they would have to say that they were wrong before, and that’s bad optics.”
Kevin Stone (firstname.lastname@example.org) writes from Arlington, Texas
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“Did the FDA Sabatage a Non-Addictive Pain Killer (Guest: Charles L. Hooper), Heartland Daily Podcast, July 12, 2023.