The sketchy past of the new CoronaVirus Czar, per The Daily

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The Sketchy Past of Trump’s Coronavirus Vaccine Czar
THE BEST PEOPLE

As a Pharma executive, Moncef Slaoui helped misrepresent scientific research on the safety of a diabetes drug. Now he’s helping run Trump’s Operation Warp Speed.
Paul Thacker
Published Jul. 07, 2020 4:39AM ET
Susan Walsh/AP

In May, President Trump tapped Moncef Slaoui to become what was dubbed his “Coronavirus Czar” and lead Operation Warp Speed, the White House initiative to expedite a coronavirus vaccine. Along with Gen. Gustave F. Perna, Slaoui has set up temporary offices on the seventh floor of the Department of Health and Human Services to assemble plans to test new vaccines.

Slaoui is a molecular biologist and immunologist and was chairman of vaccines at GlaxoSmithKline (GSK), one of the world’s largest pharmaceutical companies, where he worked for 30 years. Industry leaders, predictably, praised the appointment, and watchdogs like Public Citizen said his background was too corporate. Meanwhile, experts have been concerned that Operation Warp Speed has issued no public standards or explanations for choosing vaccine candidates and may rush vaccines through approval.
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An understanding of Slaoui’s biography and his time at GSK may add to those concerns. While working for the Pharma giant, Slaoui helped misrepresent scientific research on a drug that had harmed tens of thousands of Americans. Since the Trump administration has shifted its COVID-19 strategy to favor vaccine development, this means America’s hopes for addressing the pandemic rests with someone who was at the epicenter of one of the more controversial episodes in recent drug development.

Back in 2007, Avandia was GSK’s $3 billion-per-year blockbuster diabetes drug, when Dr. Steve Nissen of the Cleveland Clinic published a study in the New England Journal of Medicine that found that it increased the risk of heart attacks and deaths in patients. With the future of Avandia in doubt, the company’s share price fell 7 percent, wiping out billions of dollars of value. GSK was in a serious bind. But instead of opening its books, it responded by misleading the public, federal agencies, and Congress about the drug’s dangers. Slaoui helped the company in this deception. At the time, he was GSK’s chairman of research and development, and when he was hauled before Congress to testify to Avandia’s safety, he offered a rosy assessment that downplayed the drug’s risks.

“[N]ot only is Avandia effective, it is actually superior to the most widely used medicines” Slaoui testified at one point, adding at another: "We also diligently communicated to physicians and patients Avandia's scientifically established safety risks."

I know this, because I was the U.S. Senate Finance Committee’s lead investigator on the bipartisan investigation of GSK and Avandia, and our reports found that GSK had bullied critics of the drug, hid data, and misled the public. By testifying before Congress and the American public that the drug was fine and by working with his colleagues to undermine a study that found it was dangerous, Slaoui assisted GSK’s strategy to deny the drug’s dangers, which ultimately led to a $3 billion federal fine to settle criminal and civil liability related to several of the company’s drugs, including Avandia. The month after Slaoui testified, FDA scientists presented an analysis estimating that Avandia had caused approximately 83,000 excess heart attacks in America since coming on the market.

In a statement to The Daily Beast, Health and Human Services spokesperson Michael Caputo defended Slaoui from accusations that he’d acted unethically: “Any allegation that Dr. Moncef Slaoui lied to Congress is blatantly false, defamatory per se and begging for legal action, so you should probably lawyer up.” A GSK spokesperson, meanwhile, insisted that the company had “acted appropriately and responsibly in its management of Avandia.”

“With respect to Dr. Slaoui, the testimony provided by Dr. Slaoui back in 2007 was—and remains—accurate,” the spokesman added.

At the time when it hit the market, Avandia was hailed as a major breakthrough for patients with type 2 diabetes, promoted even as a safer alternative to other drugs on the market. But there were warning signs early on about the cardiovascular risks that came with the medication—warnings that made their way to the FDA.

When the NEJM published its Avandia study in May 2007, our committee and two House committees launched investigations.

Slaoui and GSK were defiant. During a later House hearing, Slaoui testified that the NEJM editorial “cherry-picked data points when the data taken as a whole supports the safety profile of Avandia,” and he alleged that GSK “communicated diligently with the FDA.” In fact, the story was quite different. The Senate Finance Committee found that GSK’s own scientists had reviewed the NEJM study and found it statistically sound, and the company later pleaded guilty for failing to report safety data about Avandia to the FDA.

Much of Slauoi’s testimony was not fully forthright, as we documented through emails made public in our 342-page committee report that we released a few years later. This report took so long because I had to personally review over 250,000 pages of documents submitted to the Committee by GSK, FDA, and several research institutes. It took hundreds of hours to do this, followed by review by Committee experts, as well as Senate legal counsel. Slaoui is one of only a handful of GSK executives named in the report.

After reading the report, Yale cardiologist Harlan Krumholz wrote that it "read like a spy novel.” Analysts at UBS predicted that GlaxoSmithKline could face legal liability of up to $6 billion. But this was only partly about money; experts also warned that tens of thousands of people were harmed by the drug.

For GSK, the NEJM study finding harm was a massive problem. But how they reacted to it made matters even worse. When a scientist submits a study to a journal, that journal’s editors have the manuscript reviewed by outside experts called peer reviewers. As we documented in the Senate Finance report, shortly after Dr. Nissen of the Cleveland Clinic submitted his paper on the dangers of Avandia to the NEJM on May 2, 2007, a peer reviewer breached the journal’s ethical rules and leaked the study to GSK. This gave the company several weeks to go over the study and prepare a public relations campaign to undermine it, all before it was made public. And that’s precisely what they did, circulating the paper to dozens of GSK’s executives to analyze........