(CN) — Five days after President Donald Trump touted hydroxychloroquine as a game-changer in the fight against Covid-19, the Department of Health and Human Services awarded PPD Development a $750,000 contract to develop a treatment protocol for expanded access to the antimalaria drug.
A North Carolina-based researcher, PPD for most does not have the same name recognition associated with Sanofi, the French pharmaceutical giant that manufactures a branded form of hydroxychloroquine. Some two decades ago though, its oversight of a Sanofi-Aventis drug clinical trial tied it forever to one of the industry’s rare prosecutions.
Sparking criminal prosecution, nationwide litigation and a congressional hearing, study 3014 of an antibiotic called Ketek put doctor Marie Anne Kirkman Campbell in prison for fraud. Campbell served 57 months after pleading guilty to having fabricated documentation supporting the existence of a fictitious subject.
The FDA ultimately approved Ketek in April 2004, despite Campbell’s plea one month earlier, but the drug was largely pulled from the shelves three years later after it was linked to dozens of cases of liver failure.
“Our investigation found that Dr. Kirkman Campbell's site did not adequately address these issues and that Aventis and PPD did not adequately follow up to explain the data discrepancies,” the FDA wrote in its 2007 warning letter to Sanofi-Aventis.
Earlier that year, PPD’s research associate Ann Marie Cisneros told the congressional committee investigating it: “What brings me here today is my disbelief at Aventis’s statements that it did not know that fraud was being committed.”
“Mr. chairman, I knew it,” Cisneros emphasized. “PPD knew it, and Aventis knew it.”
The Courthouse News database shows at least seven lawsuits against Sanofi and PPD in connection with the Ketek study. PPD did not respond to a request for comment.
Some 17 years after Campbell's conviction, PPD now stands tasked with expanding access to the drug hoped to treat, and possibly even prevent, Covid-19, the deadly respiratory disease caused by a new coronavirus.
Trump, who has an indirect and fairly small financial stake in Sanofi, has been touting the promise of hydroxychloroquine since the first briefing of his White House coronavirus task force.
“I have to say, if chloroquine or hydroxychloroquine works — or any of the other things that they’re looking at that are not quite as far out — but if they work, your numbers are going to come down very rapidly,” the president speculated on March 19, as infections and deaths continued to surge across the country.
PPD’s contract began five days after that briefing. It has an anticipated end date of April 21.
Sanofi only sells its branded version of hydroxychloroquine outside of the United States, following a 2013 divestment deal.
“We were not made aware of President Trump’s announcement on Plaquenil (hydroxychloroquine) as a potential treatment for COVID-19,” Sanofi spokesman Nicolas Kressman said. “We heard about it in real time along with the American public.”
In the U.S., the marketing and sale of Plaquenil is done by Advanz, formerly known as Concordia, a Swiss company that owned Covis Pharma. Sanofi on Friday offered 100 million doses of Plaquenil to governments worldwide if studies show it can be safely used to treat Covid-19 patients.
Following his enthusiastic endorsement of hydroxychloroquine on March 19, Trump has falsely claimed in multiple briefings and on Twitter that the FDA approved its use against the novel coronavirus and that the drug cannot hurt patients.
“There is no U.S. Food and Drug Administration approved product available to treat Covid-19,” the agency emphasized on a fact sheet for patients receiving that treatment under its emergency authorization.
Research has ramped up worldwide to fortify the hopes for the drug with sound science. At press time, the U.S. clinical trials database shows 61 studies into various uses of hydroxychloroquine for use against Covid-19. Of these 21 have been taking place in the United States.