Propulsid: Lucrative Drug, Danger Signals and the F.D.A.
The New York Times (free registration required) has an investigative piece about Propulsid, a once popular drug used for gastric reflux disease, primarily in children:
Dozens had died and more than 100 patients had suffered serious heart problems by March 1998 after taking Propulsid, a popular medicine for heartburn. Infants, given the drug to treat acid reflux, seemed particularly at risk. Federal officials told Propulsid’s manufacturer, Johnson & Johnson, that the drug might have to be banned for children, or even withdrawn altogether. Instead, the government and the company negotiated new warnings for the drug’s label – though not nearly as tough as regulators had wanted.
Propulsid had a good year anyway. Sales continued to surpass $1 billion. Johnson & Johnson continued to underwrite efforts that promoted Propulsid’s use in children. A survey that year found that about 20 percent of babies in neonatal intensive care units were being given the drug.
Two years later, as reports of heart injuries and deaths mounted, Johnson & Johnson continued defending the safety of Propulsid, but then pulled it from the market before a government hearing threatened to draw attention to the drug’s long, largely hidden, record of trouble.
And who was FDA Commissioner during the period in question? David A. Kessler, M.D.
Under Dr. Kessler’s leadership, the FDA took a number of steps to become more consumer-oriented. The Nutrition Labeling and Education Act (1994) was passed in order to make food labels more useful to the consumer. The FDA also was able to cut the length of the drug approval process nearly in half. In addition, Dr. Kessler oversaw the ban of silicone breast implants and took on the tobacco industry in order to tighten regulation.
And the Lefties complain abut Republican appointees being too close to industy or the companies which they regulate.
These problems happened all within the Clinton Administration.
Of course, this is not mentioned in the piece.