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Vytorin: No Proof It Works, No Proof It Causes Cancer

In 2002, when the US Food and Drug Administraiton (FDA) approved the generic drug, ezetimibe, for its ability to lower cholesterol, the agency did so on the basis of just a few very small clinical trials of very short duration, all of them conducted by the very people who would market the drug. Since then, controversy has surrounded Vytorin and Zetia, two brand-name drugs containing ezetimibe. It seems that there is no conclusive proof that it works and no conclusive proof that it causes cancer. Or not.

Ezetimibe alone is marketed as Zetia while ezetimibe in combination with a statin is marketed as Vytorin. The drug manufacturers, Merck and Schering-Plough, enjoy sales that topped $5.2 billion in 2007, from just the sale of Zetia and Vytorin alone. On a global basis, more than three million people take one or the other of these two prescription medications every day.

Unfortunately, there is no proof that either formulation of ezetimibe increases a person’s life or reduces one’s risk of heart attack, two claims widely associated with these drugs. In fact, two trials, conducted by the drug’s co-manufacturers, have recently been made public, only adding more controversy to the issue. Neither trial could prove that Vytorin actually works as expected.

Three entirely different clinical trials, the results of which were published just last month, reveal a 40% increased chance of dying from cancer while taking these drugs, a claim that has fueled even more controversy.

As more and more questions arise as to the safety and efficacy of ezetimibe, some of the nation’s leading cardiologists are voicing the opinion that, at this point in time, medications containing ezetimibe should simply not be sold. The controversy has spread to the New England Journal of Medicine, which is expected to publish two articles plus an editorial, online today, that address these concerns.

Critics and advocates alike agree that more comprehensive studies must be undertaken before there is any hope of proving the safety and effectiveness of ezetimibe. At minimum, a trial lasting four years or longer and involving no less than 10,000 patients is required in order to draw a convincing conclusion.

No such trial has ever been conducted on ezetimibe but Merck and Schering have such a trial underway at last. The pharmaceutical giants began their long-term, extensive study of the effects, both good and bad, of ezetimibe in October 2005, three years after the FDA gave the approval to sell these drugs. The end date of the trial has been repeatedly extended, with 2012 named as the completion date currently scheduled.

By 2012, the expectation is that tens of millions of people will be taking either Zetia or Vytorin, whether they work or not. US sales have dropped by 40% so far this year, a direct result of the controversy surrounding the drug. As to whether or not these tens of millions of people will safely get the medical benefits promised by the drug’s makers, the answer lies in the future, once a more significant pool of data has been collected and analyzed.

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