Vytorin poised to benefit from controversial US guidelines
pharmafile | July 26, 2004 | News story | |Â Â Â
New US guidelines for lowering cholesterol targets in at-risk patients have stirred controversy after experts were accused of not declaring their links to the pharmaceutical industry.
The row has erupted just days before Merck and Schering-Plough's new two-in-one cholesterol pill Vytorin (Zocor and Ezetrol/Zetia combined) is expected to gain FDA approval, further intensifying competition in the market worth $30 billion worldwide.
The government's National Heart, Lung and Blood Institute (NHLBI) produced the guidance, recommending that doctors should aim to lower cholesterol levels in high risk patients to below 70 mg/dL rather than the current guidance of 100mg/dL.
The guidance was updated because of compelling new evidence from a number of trials, including ones looking at high-dose of Pfizer's market leading Lipitor which suggest direct benefits from lower cholesterol.
Dr Scott Grundy of the American Heart Association and chair of Adult Treatment Panel III (ATP III), the expert panel which produced the recommendations said: "The lower the better for high-risk people. That's the message on bad cholesterol -low-density lipoprotein (LDL) cholesterol – from recent clinical trials," he said.
The recommendations are particularly good news for pharma companies who manufacture cholesterol-lowering drugs – panelist Dr James Cleeman estimated the new guidelines could see seven million more patients on cholesterol-lowering drugs in the US, in addition to the 36 million already on medication.
The integrity of the guidelines and the doctors on the panel was thrown into doubt when Newsday revealed a few days later that six of the nine experts had received grants or consulting or speakers' fees from companies in the statin market, according to published material from 2001.
Consumer groups Public Citizen and Center for Science criticised the guidelines, with the former's co-founder Sidney Wolfe telling the Associated Press: "These people should be disqualified from being the principal authors of publications that have the imprimateur of the government on it.'
The NHLBI responded to the accusations by publishing a full financial disclosure for the nine panel members, with only Dr Cleeman having no financial relationships to disclose.
Dr Cleeman insisted the new guidelines were based entirely on clinical evidence from five drug studies since 2001, and their recommendations had been peer reviewed and endorsed by around 80 experts.
Schering-Plough chairman and chief executive Fred Hassan is keenly anticipating the launch of Vytorin as a boost to the ailing company's revenues, and was quick to underline what the new guidelines meant for the market.
"The potential of this exciting product may also benefit from the new and more aggressive cholesterol-lowering recommendations just issued by health experts for patients at high risk of heart attacks," he told investors.
Lipitor's dominance of the market, however, looks hard to challenge – Pfizer just having reported second quarter revenues of $2.3 billion, up 17% over last year.
Karen Katen, executive vice president of Pfizer said: "fresh evidence on statins, and the new US guidelines it has driven, portend more growth potential for Lipitor."
