Back in 1998, a curious new diabetes drug piqued the interest of David Willman, a staff reporter for the Los Angeles Times.
The drug was Rezulin, which in 1997 had become the quickest diabetes pill to ever be approved by the FDA. Willman started hearing about the questionable safety profile of the fast-tracked drug being marketed directly to consumers.
So he got the okay to pursue the story by a Times editor. Weeks into his studying up on the issues at hand, a story of international intrigue was unfolding.
“I’m ready to go and then a little bit of my past came back to haunt me: Right around the third week of January of 1998, I learned that the President of the United States was in quite a predicament,” said Willman.
That predicament: the Monica Lewinsky scandal, which Willman would cover day-in, day-out for the next seven months.
But once his coverage of the scandal was complete, Willman dove back in to investigating how the U.S. Food and Drug Administration (FDA) goes about deciding whether to approve the marketing of new prescription drugs.
What started as an investigation of Rezulin resulted in a heavily reported, damning article, “How a New Policy Led to Seven Deadly Drugs,” which won the 2001 Pulitzer Prize for Investigative Journalism.
In the article, Willman detailed the ultimate human cost of both a George H.W. Bush-era law, the Prescription Drug User Fee Act, and a subsequent Bill Clinton directive for the FDA to “trust industry as ‘partners, not adversaries.’”
Willman was able to link nearly 1,000 deaths to seven drugs that were fast-tracked through the FDA approval process.
Of these drugs, Willman wrote, “The seven drugs were not needed to save lives. One was for heartburn. Another was a diet pill. A third was a painkiller. All told, six of the medicines were never proved to offer lifesaving benefits, and the seventh, an antibiotic, was ultimately judged unnecessary because other, safer antibiotics were available.”
Now, Willman reflects on the reporting process he undertook for that story.
Before I went out and really started pounding the pavement and trying to talk to the human beings who might help me unlock what happened here, or point me in directions, I started learning about how the pancreas works. I learned the regulatory structure at the FDA, what it takes to approve a drug.
I’m getting less ignorant by the hour. This is all helpful. It’s a pretty steep challenge for a liberal arts major. The first thing you have to come to terms with is to acknowledge what one does not know. And it’s an awful lot, all the time. I was in just really intensive ignorance abatement and trying to get up to speed so I could maybe get traction with subject-matter experts and then real sources who can point me in the right directions.
Not all of us in media are getting drive-by quotes, exploiting people for quick quotes and moving on. I need direction because times a-wasting. The documents are great, but you better have some notion of where you need to be looking and then what you need to be looking for within that dataset. Otherwise, you’re wasting your time and you’re not going to be employable for too long.
My initial source told me I ought to talk to a certain guy. He said, ‘He just left the agency and he’s on his way to take a job in a foreign capital. But, he’s up at Chautauqua and he’s going to be there, I don’t know, maybe another six seconds or so, you ought to get up there.’
So, bam, I did. I literally landed in Buffalo at 10:00 or 11:00 at night, drove across the state to Chautauqua. I called him ahead of time and he agreed to speak with me. I spent about eight hours with him. It was an entirely confidential interview. It was very helpful to me.
He told me there was someone with an Armenian name, an FDA medical officer, who was involved and he gave me the impression that this particular medical officer wasn’t on the team Rezulin bus that had just sprinted through the halls of the FDA, so I immediately made a note to myself. ‘I want to talk to him.’ Well, how to find him? That’s a tough one. With the help of a researcher, I got a list of some FDA medical officers from an FDA website. I can’t remember if there was more than one Armenian, but there was one that, you know, that could be the one.
I went to his residence, and I went a couple times. And he wasn’t home. Finally, I think on the third one, waiting in the driveway, I’ve already pounded on the door. And here, this guy pulls up and he’s got a couple of sacks of groceries in his hands and I tell him who I am.
He said something to the effect of, ‘I’ve been told not to talk about this, but people are dying now. So, come on in.’
And I spent probably two and a half hours with him that night, and substantial time thereafter, all off the record because he was at risk for being fired if anyone knew that that he was talking to a reporter.
What had happened was that medical officer, Dr. John Gueriguian, had reviewed Rezulin. He had written a medical review of it and he had recommended against approval.
His superiors decided, at the urging of Warner-Lambert Park-Davis, that they didn’t like his review. And so his review disappeared. It was taken out of the FDA files. My FOIA request obviously did not elicit that review, ultimately. But the chap that I met with at Chautauqua, who was one of Dr. Gueriguian’s superiors, he was courteous enough to put that review in an encrypted email and to share it with Warner-Lambert Park-Davis before an FDA advisory committee considered whether or not to recommend approval of that drug.
One of the things that fortified my determination to deconstruct what happened with this drug is that the NIH had issued a curious press release in June 1998. It signaled the cancellation of what had been the largest clinical trial related to preventing Type 2 diabetes in the nation’s history. A patient had died, and of course, that patient is not named in the press release; we have no idea where that patient is, but there were some 20 centers around the country that were participating in this nationwide clinical trial.
I was working every source I could possibly find, and I was in contact with a lot of MDs who were being paid by Park-Davis-Warner-Lambert to participate in clinical trials, and they had picked up rumors. And so we checked coroner records in the St. Louis area.
We came across a death there. I ultimately went to East St. Louis and was able to confirm, through those records and with the family, that Audrey LaRue Jones died from Rezulin.
I wanted to find out how it was that Rezulin, a drug with no established ability to prevent diabetes, had come to be selected for use in the NIH’s prestigious, yet ill-fated, clinical trial. So, I was able to sit down with the NIH’s top diabetes researcher, arguably the top diabetes researcher in the federal government.
And, so I wanted to ask him questions about how all this happened. I was able suss out that this NIH researcher, who was in charge of administering the clinical trial, along with some colleagues, was contemporaneously on the payroll of Warner-Lambert Park-Davis as a consultant. And isn’t that special?
I continued working on Rezulin stories through 2000. The L.A. Times got a new top editor in 2000, John Carroll, who thought this stuff was pretty important, and really, really pushed for me to go beyond Rezulin and look at the bigger question of, ‘What about other drugs that have been fast tracked, and in the same timeframe by the FDA? What about that?’
I had obtained the review packages that could be obtained from the FDA for at least 60 drugs that were reviewed and approved from the timeframe of 1993 through 2000. That’s when this new paradigm of, ‘We’re going to review drugs faster, and with these standards.’