Note: Previous posts in the Protocol 007 series include:
Protocol 007: Merck Denies Fraud, But Feds Seek New Mumps Vaccine as Cases Spread
Protocol 007: Feds Urge Judge Not to Dismiss Mumps Vaccine Suit
“Protocol 007”: Merck Scientists Accuse Company of Mumps Vaccine Fraud that Endangers Public Health
By Dan Olmsted and Mark Blaxill
Scrawled on a single sheet of paper, an FDA inspection form appears to back whistleblower allegations that pharmaceutical giant Merck committed fraud to convince the government its mumps vaccine still works.
The bigger question appears to be: Why didn’t the FDA do anything about it?
The document below, obtained by Age of Autism under a Freedom of Information Act request, is dated August 6, 2001. The FDA inspector who showed up that day at Merck’s vaccine laboratory in West Point, Pennsylvania, noted “raw data is being changed with no justifications.”
“Spreadsheets used to determine questionable results and retesting clinical samples for [redacted] has not been validated,” the inspector adds.
Faking data to hide the real lab results is at the heart of the claim by two former Merck scientists, who filed suit under the federal whistleblower statute. Virologists Stephen A. Krahling and Joan A. Wlochowski say they witnessed the fraud firsthand when they worked at the Merck vaccine laboratory in West Point between 1999 and 2002, and were pressured to participate.
Ironically, the fact the FDA investigated after Krahling triggered the inspection is being cited by the drugmaker in its effort to dismiss the suit.
“They [the whistleblowers] are asking the court to muscle the FDA out of the way and decide on the science,” Merck attorney Eric Sitarchuk told a federal judge last week, according to a report by Law360. “It's precisely that problem that's why [a whistleblower] case can't be based on the alleged falsity of a label” describing the safety and efficacy of the vaccine.
The suit was unsealed in federal district court in Philadelphia last summer, soon after the Justice Department, which had been studying the allegations for more than a year, declined to intervene on the whistleblowers’ side. As we reported then, the alleged fraud was a multi-year effort to hide the fact that the mumps vaccine is no longer anywhere near as effective as Merck claims and may have led to scattered mumps outbreaks around the country.
The fraud was dubbed Protocol 007 and widely known and approved within the company’s vaccine division, according to Krahling and Wlochowski.
In federal court last week, a lawyer for the whistleblowers argued that Merck’s deception meant the Centers for Disease Control and Prevention spent hundreds of millions in taxpayer dollars on a vaccine that didn’t work as promised. The mumps vaccine is a component of Merck’s MMR-II – mumps, measles and rubella – shot. It is the only mumps vaccine currently available in the United States.
Merck could face huge financial penalties and even lose its U.S. license to manufacture the vaccine if found guilty.
“Why would Merck go to the extreme extent of falsifying and manipulating the data it they didn't themselves believe this would have affected the government's purchase?” asked Gordon Schnell, an attorney for the whistleblowers. “All we need to show is that Merck concealed information to keep the government purchasing hundred of millions of dollars of the vaccine.”
Merck says the suit is without merit and the mumps vaccine is safe and effective, but it has not specifically denied its employees engaged in the conduct alleged by the whistleblowers – arguing instead that they have no standing to sue. That may be because the documentary evidence is quite strong, including an instruction sheet on how to commit the fraud, allegedly written and distributed internally by the company scientist in charge of the project: “Objective: Identify a mumps neutralization assay format [testing procedure] that permits measurement of a greater than or equal to 95% seroconversion rate in MMRII vaccines.”
Protecting 95 percent of those who get the shot against mumps is the standard required for continued government approval of the vaccine. According to the whistleblowers, the only goal all along was to reach that number in whatever way possible.
“Merck set out to conduct testing of its mumps vaccine that would support its original efficacy finding,” according to the lawsuit. “In performing this testing, Merck’s objective was to report efficacy of 95 percent or higher regardless of the vaccine’s true efficacy. The only way Merck could accomplish this was through manipulating its testing procedures and falsifying the test results. … Krahling and Wlochowski participated on the Merck team that conducted this testing and witnessed firsthand the fraud in which Merck engaged to reach its desired results. Merck internally referred to the testing as Protocol 007.”
Krahling had alerted the agency to what he said was a frantic scene: his bosses were changing test results that showed the mumps vaccine wasn’t working; destroying garbage-bags full of evidence to keep the fraud from being exposed; and lying to FDA regulators who came to the lab.
The fact the FDA investigated, but took no apparent action in the face of such evidence, raises another question: What didn’t the FDA do, and why didn’t it do it? Strangely, the agency appears to have come back to the plant several times after it was originally summoned by Krahling, but focused instead on comparatively innocuous production violations.
“Merck & Co. Inc. has been cited by the U.S. Food and Drug Administration for failing to follow proper sterility and testing procedures at its vaccine plant in West Point, Montgomery County, according to federal inspection reports,” Linda Lloyd reported in the Philadelphia Inquirer on January 9, 2002, five months after the visit triggered by Krahling.
“U.S. regulators, who inspected the plant in August and again during the fall, found many quality-control problems, including leaking ampules during drug packaging, flawed documentation for rejected drug batches, and workers who did not follow proper sterility procedures, those records say.”
The original August 2001 inspection was clearly the one triggered by Krahling that led to his whistleblower suit. The article notes, “FDA inspectors visited Merck's West Point plant on Aug. 6 and returned several times between Aug. 27 and Oct. 29.”
The article quotes the handwritten findings that raw data had been changed in lab notebooks and questionable spreadsheet results had not been validated. The FDA’s actions, however, focused on quality control issues that led the plant to “voluntarily interrupt” its production lines while they were being addressed. Merck spokesman Christopher Loder told the Inquirer the problems had been identified during a “routine” inspection, which doesn’t match the events surrounding the August 6 FDA visit after being alerted by Krahling.
The scenario raises the possibility that the agency essentially ignored the deeper problem – evidence that one of the vaccines being manufactured at the plant simply didn’t work as advertised, and fraud was being committed to hide the truth – and instead slapped the firm with violations that could be described as “routine.”
Even so, the “voluntary” production stoppage may have been behind shortages in Merck vaccines that developed in 2002 and 2003, according to the whistleblowers.
The suit says testing on the mumps vaccine began in 1999, led by Senior Investigator David Krah and his second-in-command, Mary Yagodich. Merck’s Executive Director of Vaccine Research, Alan Shaw, approved the testing methodology, the suit says. (The FDA notice above about test results being "changed with no justifications" is addressed to Shaw.)
Krahling said he complained about the fraud to Emilio Emini, Vice President of Merck’s Vaccine Research Division, and brought “actual testing samples and plaque counting sheets to demonstrate to Emini the fraudulent data that Krah was directing. Emini agreed that Krah had falsified the data,” the suit said, but defended some aspects of the work.
“Emini promised to conduct an ‘internal audit’ of the mumps testing. … Emini ordered Krahling not to call the FDA. Immediately after the meeting [a Human Resources representative] approached Krahling and again threatened that he would be put in jail if he contacted the FDA.”
Shortly thereafter, Krahling was transferred to another lab, and soon left the company; Wlochowski was also transferred and left the next year. (In 2005, Emini became Executive Vice President of Vaccine Research and Development at Wyeth Pharmaceuticals. He is now Senior Vice President and Chief Scientific Officer of Vaccine Research at Pfizer.)
At the court hearing last week, a lawyer for the U.S. Justice Department told the judge that the fact the department had not intervened on behalf of the whistleblowers should not be used as reason to dismiss the case. She rejected Merck’s claim that private citizens shouldn’t be allowed to bring a whistleblower suit over fraud against the FDA.
The Justice Department’s continued interest in the case, contrasted with the apparent lack of action by the FDA when alerted to the alleged fraud, raises the specter of a potential conflict between departments in the Executive Branch. It might explain why Justice did not initially intervene but seems to be quite public in keeping the option open. Most whistleblower suits that succeed eventually gain Justice Department backing, people familiar with the process say.
One anomaly in the FDA’s August 6 inspection form stands out: the signature line. Two FDA employees are listed. The first was unsurprising, Debra Bennett, a field-based CSO (or consumer safety officer), the FDA staff charged with inspections and investigations. The second seems more unusual: Kathryn Carbone, a senior scientist from the FDA’s Office of Vaccine Research and Review. Back in August 2001, Carbone would have been well aware of the political dynamite involved in allegations of scientific fraud involving the MMR vaccine. On March 8, 2001, just a few months before, she was a panelist in the Institute of Medicine’s safety review on “MMR and Autism” and was followed on the agenda by none other than Dr. Andrew Wakefield.
Meanwhile, as we reported in June, the National Institutes of Health, like the FDA and CDC part of the Department of Health and Human Services, appears to have tipped its hand over concern about the mumps vaccine. Just as the whistleblower suit was unsealed last year, health officials awarded almost $2 million to a research team at the University of Georgia.
The goal: Find a much better mumps vaccine, in a hurry. “The fact that outbreaks had occurred in populations with over 95% coverage of two-dose [mumps] vaccine strongly suggests that the current vaccine is not effective,” according to project information filed by Biao He, a researcher at the University of Georgia who received the $1.8 million grant.
We also noted that scattered mumps outbreaks this year – possibly underreported by the CDC – are reinforcing longstanding concern that Merck’s mumps vaccine is failing far more often than it should. The outbreaks appear to be following a three-to-four-year cycle in which a new cohort of immunologically susceptible persons is exposed but lacks full vaccine protection.
The current outbreak appears centered in college-age students. While mumps is generally benign when contracted in childhood, it can be much more serious when caught later. In males it can be excruciatingly painful and even lead to sterility.
If vaccine failures are involved in the current outbreak, that would also undercut Merck’s statement that there is no safety issue involved with the alleged fraud.
Dan Olmsted and Mark Blaxill are editors of AgeOfAutism.com and co-authors of “The Age of Autism – Mercury, Medicine, and a Man-made Epidemic.”