|Vytorin continues to face conflicts. Source: Bloomberg|
The House Energy and Commerce Committee today sent letters to two prominent cardiac societies, questioning if monetary contributions from Merck/Schering-Plough influenced the their support of Vytorin following the negative results of the ENHANCE trial, according to the New York Times.
On Jan. 14, Vytorin's makers released the results of the ENHANCE study that found Vytorin is no more effective in treating patients who were genetically predisposed to having dangerously high levels of cholesterol than Merck's drug Zocor (Vytorin contains Zocor) because it did not slow the growth of artery blockages.
In a statement issued on Jan. 15, the day after the results were released, the American Heart Association (AHA) reported that the study was too limited to draw conclusions about Vytorin’s ability to reduce heart attacks or deaths compared to Zocor alone, and advised patients not to abruptly stop taking it without consulting their doctors.
However, the New York Times (NYT) reported that the AHA receives nearly $2 million a year from Merck/Schering-Plough Pharmaceuticals.
Congress will send a letter to the American College of Cardiology (ACC), which also receives drug industry money and which also released a statement advising patients not to stop taking Vytorin without consulting their doctors, the NYT reported.
The letters from the Energy and Commerce Committee are part of a broader committee investigation into the research and marketing of Vytorin, according to the NYT.
Merck and Schering-Plough have come under fire for taking roughly 21 months to release the ENHANCE study results after its April 2006 completion, with critics suggesting they were delayed because the companies knew they would be negative and wanted to protect the sales growth for Vytorin and Zetia.
Despite the previous criticism, Vytorin has emerged as a huge moneymaker for Merck with about $5 billion in annual sales globally.
However, the results have affected sales. Prescriptions for Vytorin have dropped sharply in the two weeks since the study was released, according to Verispan, a Yardley, Pa.-based market-research firm.
The report said that the total U.S. prescriptions written for Vytorin in the week ended Jan. 25 fell about 23% to 305,579 from 397,533 in the week ended Jan. 11.
Prescriptions for alone Zetia, which the Merck/Schering-Plough joint venture also markets, fell 25% to 221,478 from 294,405 two weeks ago, Verispan said.
In total, the report said that the number of prescriptions written for cholesterol-modifying medications last week fell 10% to 3.7 million from 4.1 million two weeks earlier.
Finally, the FDA is reviewing the trial as well. “Once FDA receives the final study report, FDA estimates it will take approximately six months to fully evaluate the data. After reviewing the data from the ENHANCE study, and considering all other available information about the link between LDL lowering and reduction of cardiovascular events, FDA will determine whether any further regulatory action is warranted with regard to Zetia and Vytorin and also whether any changes to FDA’s current approach to drugs that lower LDL cholesterol are warranted,” the agency said on Friday.