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Arrhythmia drug unavailable in most countries: study

By Genevra Pittman

NEW YORK (Reuters Health) - An inexpensive drug that can prevent some life-threatening heart rhythm problems is unavailable in most places, according to a new survey of doctors in 131 countries.

Quinidine prevents arrhythmias among people with Brugada syndrome, an inherited condition in which the heart's bottom chambers quiver chaotically and don't properly circulate blood.

But because quinidine is so cheap - as low as a quarter per pill - and only indicated for a very small group of heart patients, drug companies have little incentive to go through the regulatory hurdles to market it, researchers said.

"It's a problem for a small number of patients worldwide, but it's a very serious problem because they have no other alternatives," said Dr. Sami Viskin, a cardiologist from Tel Aviv Medical Center in Israel who led the new study.

"I have patients that are desperately trying to get stocks of the medication."

For their study, Viskin and his colleagues emailed questionnaires to arrhythmia specialists and heard back from 273 doctors in 131 countries. Quinidine was readily available in just 19 of those countries, including the U.S., Australia, Brazil and France.

Doctors in 99 countries - more than three-quarters of those surveyed - said quinidine was not accessible to them. That was consistent across most of Africa, Asia and Eastern Europe.

In the remaining 13 countries, heart doctors had to go through specific regulatory procedures to get quinidine, which could take anywhere from four days to one month.

On their surveys, doctors recounted treating a total of 22 patients who had serious arrhythmias that may have been due to lack of quinine, including two people who died, the study team wrote in JACC: Journal of the American College of Cardiology.

Only about one in 10,000 people inherits Brugada syndrome and even fewer have symptoms, according to Dr. Michael Ackerman, who studies heart disorders at the Mayo Clinic in Rochester, Minnesota.

In the U.S., most people who have arrhythmias due to the disease are treated with an implantable cardioverter-defibrillator (ICD), he said. But those cost about $20,000.

"Quinidine has been a game-changer for those countries where they don't have similar resources," Ackerman, who was not involved in the new research, told Reuters Health.

Doctors can also treat people with Brugada syndrome and another type of so-called ventricular fibrillation with electric shocks, but the arrhythmia typically returns, Viskin said. Sometimes those people need to have their hearts shocked as often as 20 to 30 times a day.

"For those cases, you need quinidine right away, not next week," the researcher told Reuters Health, noting that he has sent the drug via FedEx to multiple countries.

The former producer of quinidine, AstraZeneca, stopped selling it by 2006. The drug had previously been used for other heart rhythm problems, but was replaced by newer medications that caused fewer side effects.

"The main reason was that it was not worth it for them to produce and sell quinidine. It's a cheap drug… and the market is small," Viskin said.

He said his patients were concerned because Sanofi had recently stopped selling quinidine in Europe.

A representative for the company said it had experienced a supply disruption, and making its version of quinidine "available is a priority for Sanofi and we are doing everything possible to remedy the situation as soon as possible."

AstraZeneca did not provide a comment by deadline.

"The bang for the buck is not going to be there as a motivator to provide this drug," Ackerman said. If a company was to produce it widely, he added, it would be out of an act of philanthropy.

"We are aware that patients all over the world die because they cannot get medications because they are too expensive, for example the anti-AIDS medications for Africa," Viskin said.

"But here you have a situation where patients are dying because they cannot get a medication, only because it's too cheap."

SOURCE: http://bit.ly/P8Btq1 JACC: Journal of the American College of Cardiology, online April 9, 2013.

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