Recall Natrecor, Eric Topol demands

When Dr. Eric Topol speaks, the world listens. He is considered to be an authority on the subject of heart diseases. He is also not shy about saying what is on his mind. Traditionally, it is mostly the scientists who have been interested in what he has to say but after he highlighted the dangers of Vioxx, millions of people worldwide want to know what he thinks.

After his criticism of Vioxx early on did not have much impact on either Merck or FDA, he was proved right later on after more evidence about risks of Vioxx was published. Vioxx was eventually recalled last year.

Now he is on his next mission - to force FDA and Scios (a subsidiary of Johnson & Johnson) to recall Natrecor. He is asking why a drug that causes a lot of side effects on your kidney and costs a fortune ($500 a dose, while cheaper alternatives that cost just ten bucks are available) is still on the market? He shared his thoughts on the matter in an article in the New England Journal of Medicine.

Since Natrecor was approved, a lot of questions have been raised about the safety of the drug, but nothing has changed due to inertia at the FDA. Plus, some doctors refuse to ignore scientific research since administration of Natrecor is so lucrative. Like many other drugs, Natrecor was approved by the FDA based on sketchy safety data and then FDA has chosen to look the other way while the company markets the drug aggressively. (Related article: Natrecor increases risk of death)

Some other statistics will suprise you. Dr. Topol finds that for each American doctor there are five salespeople. He is recommending that Natrecor be recalled despite the fact that a panel at Cleveland Clinic did not act on this matter. In his opinion, "Nesiritide (Natrecor) has not yet met the minimal criteria for safety and efficacy. Until a trial definitively proves that this drug reduces the risk of death or repeated hospitalization for heart failure, there will be questions about the appropriateness of the drug's use or even commercial availability. We need a tune-up of our procedures to eliminate indiscriminate use of drugs, such as nesiritide, when there is not proper evidence of their safety." (Related article: Natrecor label revision)

By the way, our friends in Europe do not think that the drug is safe enough to be used by Europeans. In the meantime, Scios has written a letter to doctors to be more careful in prescribing Natrecor.

Recommended article: Natrecor prescription guidelines changed