Two U.S. Democrats said on Friday their investigation had raised questions about how Merck & Co Inc and Schering-Plough Corp documented a key meeting about a controversial study of their Vytorin cholesterol drug.
House of Representatives Energy and Commerce Committee Chairman John Dingell and Rep. Bart Stupak said company documents showed minutes from a November meeting of outside experts reviewing the study were "created after the fact."
The documents showed one of the experts complained the minutes did not reflect all the opinions expressed, although he said a later summary did.
A company spokeswoman said participants in the meeting had been told no minutes would be produced, so none were — until the Food and Drug Administration later requested them.
Dingell and Stupak, chairman of the oversight and investigations subcommittee, are probing why the companies did not release the study findings until 20 months after it ended.
The study showed Vytorin was no better than a cheaper generic drug at reducing plaque in neck arteries.
Vytorin, which had sales of $5 billion a year, accounts for the majority of Schering-Plough's profits. Shares of Merck and Schering-Plough, which sell Vytorin through a joint venture, have fallen sharply since the results of the study, named Enhance, were released in January.
Dingell and Stupak, both Michigan Democrats, said they "continue to have serious concerns regarding the conduct and reporting" of the Enhance trial.
Officials at Schering-Plough could not immediately be reached for comment.
In a letter to the companies, the lawmakers asked why the minutes were written "after the participants were told there would be no minutes or transcript of the meeting?"
Merck spokeswoman Mary Elizabeth Blake said meeting participants were told no minutes would be produced but the FDA later requested them. The writing of the minutes, based on notes, began in late November after the FDA inquiry, she added.
The House committee began investigating Vytorin on December 11. An e-mail released by the lawmakers shows the minutes from the November meeting being sent to one of the experts on December 19.
That expert, Dr. James Stein, a cardiologist at the University of Wisconsin, complained to Schering-Plough that the minutes did not provide a full picture of the panel discussions, according to another e-mail.
"Some parts of the minutes do not accurately reflect the divergence of opinions expressed at the meeting," Stein wrote.
He also said he had "a hard time calling this document 'minutes"' because there was no audio or written transcription from the meeting.
The document Stein was responding to was a draft version released by the committee, said Merck's Blake. "All panel members agreed that the final minutes were accurate."
Stein, in a telephone interview with Reuters, said he and other panel members did agree that a final meeting "summary" provided "a reasonable reflection of what happened" at the meeting.
The lawmakers asked the companies to provide the committee with more information on the November meeting as well as on marketing and other issues.
They also asked the companies if they had suspended Vytorin television ads at the FDA's request and whether they would resume commercials in the near future.