Update for those following the cholesterol-Vytorin-ENHANCE story

The Congressional investigation has added insider trading to its inquiry. In a letter on Tuesday addressed to the Chairmen and CEOs of Merck & Co. And Schering-Plough Corp., the U.S. House of Representatives Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations said they’d discovered company officer Carrie Smith had sold significant quanities of Schering-Plough shares prior to the public release of the ENHANCE results. [Reported here.]

“This raises questions as to whether this sale was related to any knowledge of the study’s results,” said the Congressional letter. Therefore, the Committee also wants answers from Schering-Plough and Merck as to what meetings were held to discuss the ENHANCE trial results and all records of briefings to corporate officers; if any corporate officer had knowledge of the results of any preliminary results prior to the public release on January 14th; and all records of stock sales by corporate officers between the study’s completion and when the results were made public nearly two years later.

The Congressional investigation also wants the results of the secondary analyses of the ENHANCE trial that have also not yet been released.

Today’s issue of FDA News reports that the Congressional investigation is also looking into the continued advertisements for Vytorin that may have been run while company officials knew the drug provided no benefit compared to a generic. Over the weekend, the companies had a full-page ad in the New York Times that said that Vytorin and Zetia users “may be worried about recent news stories questioning the benefit of these medicines...on the basis of a single study that has generated a lot of confusion.”

As Reuters reported, the ad cited the drugs’ ability to lower LDL cholesterol and urged patients to follow their doctors' recommendations on taking prescribed medicines. “All of us at Merck and Schering-Plough proudly stand behind the established efficacy and safety profiles of Zetia and Vytorin,” the ad said.

Yesterday, Merck & Co and Schering-Plough announced they had temporarily suspended television advertising for Vytorin and Zetia. Their new print campaign in U.S. newspapers continues, saying they “proudly stand behind the established efficacy and safety profiles of Zetia and Vytorin.” According to research firm TNS Media Intelligence data, the two companies spent around $102 million on DTC advertising for Vytorin in the first nine months of 2007, and $83 million on Zetia.

The print ads say that Zetia and Vytorin “have been proven to lower LDL (bad) cholesterol along with diet in multiple clinical studies involving thousands of patients. Both the American College of Cardiology and the American Heart Association agree that lowering bad cholesterol is important.”

Last week, on January 16, Brandweek NRx was the first to report troubling information about these endorsements from the two largest organizations representing cardiovascular interests — the AHA and ACC — in what it called, “a carefully orchestrated media plan” surrounding the release of the ENHANCE trial results. Today’s issue of Brandweek NRx is especially enlightening as it explores why these organizations would release statements urging people to continue a drug despite “a complete lack of evidence that the drug has any clinical efficacy as opposed to simply lowering lipids.”

Brandweek NRx said that the companies and AHA have not disclosed that the AHA received nearly $2 million per year from Merck and Schering-Plough and that AHA president Dan Jones has been a Merck consultant. The ACC has similar entanglements, they report. Among those who drafted its statement was Roger Blumenthal, a professor of medicine at Johns Hopkins University, who chairs the ACC’s committee on prevention of cardiovascular disease. “However, Blumenthal is also on the speaker’s bureau for Merck and Schering-Plough, and has received unspecified research grants from Merck.”

Brandweek NRx adds:

All parties claim all that money changing hand played no role in the statement by AHA. That's like claiming when a mother defends her son, that the fact he didn't ask her to do so means she didn't do it because she is his mother. Not to be cynical.

Dr. Sidney M. Wolfe, the head of the Public Citizen’s Health Research Group, a consumer advocacy group, also noted that the drug industry underwrites many professional medical organizations, raising questions about the objectivity of these groups. In the New York Times today, he criticized the link between the American Heart Association website’s cholesterol page and another page: “Food & Family, the 2 sources of bad cholesterol.” The AHA site actually takes readers to the drug company’s Vytorin website.

While some are claiming that these investigations and conflict of interest concerns are simply anti-pharma conspiracy theories, this is a smokescreen to deter consumers away from the real issues. None of this would ever have become a concern had there been transparency, and not been troubling evidence with the science, science, science, science and science surrounding the actual clinical benefits in prolonging life compared with the risks and the reporting.