Congress Miffed Over Vytorin Report & Consultant

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richard-petoThe circumstances surrounding the recently released SEAS study, which unexpectedly revealed a few dozen cases of cancer and cancer-related deaths among patients given the controversial Vytorin cholesterol pill, is apparently angering the House Energy & Commerce Committee.

As part of its ongoing investigation into how Merck and Schering-Plough handled clinical trial data surrounding the Enhance trial, the committee is now questioning conflicting data from the SEAS trial. For instance, the SEAS press release from Monday, July 21, 2008, indicated that there were 93 cancer cases among those taking Vytorin and 65 among those taking placebo, according to the committee.

But a press release issued by Oxford University’s Clinical Trials Service Unit indicated there were 102 cancer cases among Vytorin users and 67 in the placebo group. And while the SEAS release provided a probability value (p-value) for statistical significance, the CTSU release did not, note John Dingell, who chairs the committee, and Bart Stupak, who heads the Subcommittee on Oversight and Investigations.

The two Democrats are also steamed Merck and Schering-Plough ‘counsel’ insisted to the committee that the cancer deaths were an anomaly, and the report by Oxford’s Richard Peto (pictured above) would support this contention. The drugmakers also insisted they did not underwrite his report, which was submitted to the FDA. But the drugmakers refused to provide the report without “assurances” it wouldn’t be released to the public (this means you). The committee was told to, instead, get the report from the FDA, since Peto provided a copy to the agency.

And so in a letter sent today to Schering-Plough ceo Fred Hassan and Merck ceo Dick Clark, the committee write that “we are concerned that the analysis of Vytorin data conducted by Sir Richard Peto may not be as ‘independent’ as expected, given that his Clinical Trials Service Unit is conducting the Study of Heart and Renal Protection (SHARP) trial of Vytorin, also funded by Merck, Schering-Plough, and/or the joint venture. In addition, Dr. Peto has apparently submitted a copy of his full report directly to FDA, but has not made it public, an action we deem questionable.”

UPDATE: Steve Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, questioned why the study results weren’t presented in a peer-reviewed research journal. “We in medicine want the facts and science, and prefer to have it in the medical literature and not in a press conference that is highly orchestrated,” he tells Dow Jones, referring to Peto’s public presentation of the study last month in London.

“We are concerned that a study has found a significant link between Vytorin and cancer,” Dingell says in a statement. “Now, it appears that Merck/Schering-Plough and its consultant are presenting two different data sets from this study to the public. Doctors and consumers should have better information on which to base their health care decisions.”

To read Peto’s presentation from last month, a loyal reader suggests you click here.

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  1. Looks like our wonderful leaders have forgotten that MSP didn’t run the SEAS trial and they didn’t pay for Sir Peto’s “independent” analyses either. For the presentation slides from both, here’s the link: http://www.ctsu.ox.ac.uk/news/index_html

  2. Piper,

    The SEAS study was definitely funded by MSP. And do you think Peto works for free? Also, the SHARP trial with the same drugs involves him so he and his group are handsomely paid. I’m sure he wants to save his trial as well. There’s nothing independent about any of this stuff!

  3. If I were Merck or Schering-Plough, I’d really be worried about ezetimibe!

  4. Bought and paid for opinion! Need to check the money trail, particularly grants, studies and consultant fees! Form MSP right into the coffers!

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