Merck virologist recalls becoming whistleblower over maker's blockbuster MMR measles, mumps vaccine

Stephen Krahling was a published cancer researcher when vaccine maker Merck brought him on board as a virologist in 1999. That’s when he says he found himself embroiled in an all-hands-on-deck corporate emergency and became part of a scandal that’s lasted 25 years.

“When I showed up to start work at Merck they were dealing with a potential product recall," he recently told "Full Measure with Sharyl Attkisson.” "And it wasn’t something that was just casually discussed. It was a Sky is Falling level event.” 

The crisis surrounded Merck’s blockbuster-selling MMR-II against measles, mumps and rubella – and worries that it might be defective.

The problem first arose when the Food and Drug Administration began a review of vaccines in the mid-1990s and found a potency issue with the MMR vaccine. It turns out that as MMR vaccine sat on shelves waiting to be used, the live virus in it that makes the shot work was dying off to less than what the FDA-approved label claimed. That discovery triggered a series of behind-the scenes-events, though doctors and patients were none the wiser.

First, the FDA instructed Merck to start putting more of the virus into the MMR vaccine upfront, that’s called “overfilling,” so that it would be potent through its two-year shelf life, even after some of the virus died off. Merck started doing that in early 2000.

“So the problem was that these viruses degrade over time, and Merck had to calculate backward and say, 'We need to add more virus so that the stuff doesn't degrade,'” Krahling explains. “Because the FDA was adamant: 'You cannot keep distributing that vaccine if it's out of specification,’ they had to do this thing called an overfill, which is the same as if you take a glass of water and pour a lot into it till it overfills. They added more virus, vaccine virus to the vaccine for measles, mumps and rubella.”

Meantime, the FDA slapped Merck with two warnings for failing to report it had put 23 million doses of vaccine on the market that might not have met potency requirements for the whole shelf life. Merck risked losing its license to make MMR shots and future government contracts worth billions of dollars.

But even with the overfilling, the mumps virus in the modified MMR shot was still dying off too fast. Krahling was part of a team at Merck assigned to try to show it didn’t matter. Yet he says no matter what he and his fellow Merck scientists tried, repeatedly adjusting methods and parameters, they just couldn’t make the vaccine with less mumps virus stand up to FDA standards for effectiveness or efficacy.

The big shocker is that Krahling says a Merck lab official started telling him and other Protocol 7 scientists to change the data – to make it look better.

“He says, ‘Whenever you find this stuff, you just, you have to cross 'em out and write in new numbers,’” Krahling recalls the lab official saying. “At the end of the day, they just crossed out numbers and wrote in the numbers they want.”

“Falsifying documents?” "Full Measure" asked.

Krahling: "Oh, absolutely. A hundred percent. Like in the laziest way ever. I mean, just crossing it out. I mean, come on. Who can get on board with that?”

Krahling reported the alleged fraud to the FDA and eventually filed a whistleblower lawsuit against Merck for taxpayer fraud since the Centers for Disease Control and Prevention bought the allegedly faulty vaccine for years. 

The case dragged on for many years. Ultimately, it was dismissed before trial. The judge said taxpayers weren’t defrauded because the CDC knew from the start about the potency issue and alleged misrepresentations— but bought the vaccine anyway.

Meantime, experts have raised questions as to whether the vaccine’s questioned potency is why there have been measles and mumps outbreaks among many vaccinated people.

Merck has denied doing anything improper. Merck and the FDA say Merck’s vaccine is safe and effective or it wouldn’t be allowed to stay on the market.

To find out more on this story and why it turned out the way it did, watch "Full Measure" on Sunday.

For more on this story, watch "Full Measure with Sharyl Attkisson” Sunday. Attkisson's most recent book is "Follow the $cience: How Big Pharma Misleads, Obscures, and Prevails."