It's a Quinine World

If you're like me, quinine might put you in mind of this:

 source*

Or, if you're old-school, maybe this:

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But quinine actually has a very long, colorful history.Originally used in Peru to treat a variety of illnesses,  for a long time it was known as a "miracle drug". Quinine was smuggled and fought over in World War II, and Benjamin Franklin even wrote a story about it in Poor Richard's Almanac.

It was considered a classic American remedy for leg cramps, fevers, malaria, and muscle tension, until the FDA banned it from the market in 2006. The FDA had previously tried to ban quinine in 1994, citing safety concerns. Now, it only allows doctors to prescribe it for malaria and only by one company, AR Scientific Inc. I wanted to find out why.

This Washington Post article has an interesting take on the subject, but I was very confused by two quotes from the article:

1) "The FDA has issued warnings about the risks of quinine since 1994 and more recently about its minimal effectiveness in treating leg cramps. In 2006, it banned the sale of all drugs containing quinine except the branded drug Qualaquin because of the risk of serious side effects or death. "

2) "If you suffer from nighttime leg cramps, your doctor might prescribe quinine. The Food and Drug Administration has approved it for only one purpose -- to treat malaria -- but doctors can legally prescribe most medications, including quinine, 'off-label' for any treatment they deem appropriate."

So quinine is banned. Yet you can buy it here, and here, and here (albeit only in tonic water or homeopathic drugs). And doctors can prescribe it? And if it is not effective, why do people want it so badly? Why has it been used for centuries? 

I felt that there was something missing in the quinine story. The Washington Post claimed that there is little evidence that quinine works to alleviate leg cramps, but blamed that lack of evidence on poor research. The author did not cite any studies proving that quinine is ineffective. In addition, the writer mentioned that from approximately January 2006 to June 2008, the FDA received 38 reports of "serious adverse events", and that 55 percent of those reports were from people who had taken quinine for leg cramps. Which means that over the course of two and a half years in a nation of hundreds of millions of people, the FDA received 20.9 complaints associated (who knows how distantly) with quinine.

So, no, I am not convinced that quinine is all that dangerous. I referred my questions to the medical authority behind the FDA Monitor, who kindly explained that, while the FDA can say that a drug should only be prescribed for one thing, as long as it is legal for doctors to prescribe it, they may prescribe it for anything they want.

So, despite the FDA's disapproval, doctors continued to prescribe quinine for leg cramps, presumably because their patients felt it was helpful. But when the FDA forbade any other company apart from AR Scientific Inc., to produce quinine, the company was able to make it prohibitively expensive. As a result, people naturally wanted to put it on their prescription plans. Unfortunately for people who want to use it for leg cramps, the FDA's ruling makes it illegal to put quinine on prescription plans for individuals who are not suffering from malaria.

This is a complicated issue, but it is one of the most important I've covered on the FDA Monitor so far. I strongly feel the FDA was playing a game here. It is a game that put scores of companies that used to sell quinine through financial hell, while enriching one drug company. It is an example of the FDA interfering in the doctor-patient relationship as well as the economy. Now, people who had used quinine for years have to jump through hoops to get it, pay too much, or just live with pain. 

not if the FDA can help it. source*