25 December 2009

Tens of billions for a placebo?

Marketing in a white coatMatthew Harper, FORBES, January 2010

The facts show that the drug Zetia, which lowers cholesterol in the blood, should not serve as a substitute for drugs that appeared earlier and tested on a larger number of patients. The mechanism of therapeutic action of Zetia, which is produced by Merck, is poorly understood, and none of the clinical trials have proven that Zetia can prevent heart attacks. All this did not prevent Merck marketers from making a gold mine out of Zetia. Over the past seven years, they have convinced doctors to prescribe Zetia and a similar drug Vytorin (a combination of Zetia and Zocor, a cholesterol-lowering drug developed by Merck earlier) for $21 billion. In 2009, the total sales of Zetia and Vytorin were estimated at $4 billion.

In November 2009, one of the pharmaceutical companies competing with Merck conducted clinical trials of drugs that reduce cholesterol levels in the blood. The effectiveness of the drugs was evaluated by ultrasound examination of the arteries affected by cholesterol plaques. During this study, Zetia was completely overwhelmed by niacin (vitamin B3). Another clinical trial conducted in March 2008 showed that the effectiveness of Zetia was no different from placebo. Merck retorts: the methods used in these studies have many flaws.

"The success of Zetia is due to the wonders of marketing, not a medical miracle," says cardiologist Sanjay Kaul from Cedars–Sinai Medical Center. This is the problem of all American medicine: new drugs are too hastily prescribed to too many patients, while evidence that new products really help patients is being collected at a snail's pace. Merck only three years after the launch of Zetia began large-scale trials of this drug to establish whether Zetia prevents heart attacks. The tests will be completed no earlier than 2012.

Lipitor, Zocor and other statin medications block the production of cholesterol in the liver. Zetia also acts in the intestine, absorbing cholesterol from food. There is another significant difference between statins and Zetia: during large-scale clinical trials, statins have demonstrated the ability to prevent heart attacks. Statins relieve vascular inflammation, but Zetia does not. Statins increase the level of high-density lipoprotein ("good cholesterol"), while Zetia does not. However, this drug still has many supporters. "I don't share the opinion that some ways to lower cholesterol are better than others," says Daniel Rader from the University of Pennsylvania.

According to a study conducted by the consulting agency TNS, Merck has spent $741 million on advertising Zetia and Vytorin drugs in the press, on television and on the Internet since 2004.

Merck pays doctors campaigning for Zetia. Senator Charles Grassley cites the following figures: in just five months of 2008, cardiologist Michael Davidson from Radiant Research received $71,150 from Merck for lectures and consultations, and Dean of Weill Cornell Medical College Antonio Gotto – $27,146. Both defended Zetia.

Mark Pfeffer, a cardiologist at Boston's Brigham & Women's Hospital, notes another factor in the success of Zetia – doctors' trust in the results of laboratory tests. "When you have laboratory data, you are confident in what you are doing," explains Pfeffer. However, he admits, at the same time, what really matters falls out of the doctor's field of view: does the drug really prevent the disease?

Portal "Eternal youth" http://vechnayamolodost.ru25.12.2009

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