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Issue 217 Item 10

Head-To Head Study: Norvasc Vs. Diovan
Issue 217 Item 10

Jul 19, 2004

Results of study backfire on Novartis in head to head study.

In a clearly unintended gift, Novartis AG released a study that gave Pfizer Inc. boasting rights for its blood pressure medicine, Norvasc. Last month, Novartis announced the results of a clinical trial it funded to determine whether its own blood pressure drug, Diovan, would reduce cardiac-related complications and deaths better than Norvasc in high-risk patients. The study actually determined that Norvasc was better at reducing blood pressure and heart attacks.

The study was not without positive news for Diovan: It proved better at reducing the onset of diabetes. But the trial results highlight the risk for drug companies when they conduct and publicize head-to-head studies involving competitors’ products.

Analysts and doctors say they don’t see enough of such tests, known as comparative studies. And they fear that results like those in the Diovan-Norvasc study may discourage drug companies from conducting such trials.

Novartis was playing with fire, but comparative studies are becoming more common as the rising cost of medicines pushes health insurance plans to demand information about drugs to determine which offer the best value. Pharmaceutical companies are complying because they covet a place on plans’ preferred drug lists. And they need to distinguish themselves, in lucrative and competitive categories with big patient populations like cholesterol-lowering medicines — especially since many companies don’t have medicines with blockbuster potential in their pipelines.

A similar case is a study Bristol-Myers funded and released earlier this year. The study found that the then-highest dose of its cholesterol-lowering drug Pravachol was not as effective as the highest dose of Pfizer’s Lipitor in reducing adverse reactions such as stroke and even death in patients hospitalized within 10 days of heart problems.

The study indicated that lowering cholesterol beyond guidelines was beneficial, which helped Lipitor, the more powerful drug.

Novartis’ head of clinical research and medical affairs, Dr. James Shannon, said the company believed Diovan was an advance in blood pressure treatment but in order to prove it, there really was no choice but a head-to-head study against the market leader. He said conducting a study against a placebo or older medicine wouldn’t have helped Diovan in the marketplace.

Now, Novartis is hoping doctors will be moved to prescribe Diovan because its can reduce the onset of diabetes in patients at risk for cardiac complications. Diabetes is a common problem for people with high blood pressure.

Next year, Pfizer will announce the results of a study comparing Lipitor to Merck’s Zocor, which was the leader in the field when the study started seven years ago. Lipitor is now the market leader and considered more potent than Zocor.

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