"No One Asked Us"

So said the medical authority behind the FDA Monitor when I asked him about Colchicine, the ancient Greek remedy for gout.

My Big Fat Greek Medication. source*

             
After my post about Quinine, I began to wonder about other reliable drugs that were around long before the FDA, and what became of them. Starting in the 1930's, any new drugs had to be legally approved by the FDA, while older drugs that were considered safe and effective could remain on the market sans FDA approval.

As recently as 2006, however, the FDA began a new, revolutionary program known as the Unapproved Drugs Initiative. As its name suggests, this new initiative involved the FDA evaluating old, unapproved drugs for safety and effectiveness, even after they had been on the market for years.

But the FDA did more than just conduct tests and put its stamp of approval on products. As this article from the New England Journal of Medicine points out, in the case of colchicine, the FDA granted exclusivity to URL Pharma for a drug that was literally thousands of years old and previously widely available. Since then, URL Pharma raised the price per colchicine tablet from $0.09 to $4.85.

The shocking increase in price- a direct result of the sudden monopoly granted to URL Pharma for a popular drug- affected patients, businesses, and of course the government. Medicaid costs for the drug spiked, going from $1 million to $50 million annually. URL Pharma's successful suit to prevent other companies from selling colchicine only made things worse.

While it may have been unfair for URL Pharma to raise the price that high, it had to pay for an expensive drug trial and give tens of millions of dollars to the FDA. It is clear that the FDA's actions had sweeping implications for the health and finances of millions of people throughout the country.

The title of this blog post was inspired by FDAM's medical authority, who said that at a medical conference, he loudly objected to this particular action on the part of the FDA. As a physician who had prescribed colchicine for years, he saw his patients suffer when it became more difficult to obtain. They were forced to turn to other, less safe drugs, because they could no longer afford colchicine. He felt that this was yet another example of doctors being ignored by the FDA, when they are the ones who directly interact with patients and are ultimately held responsible- by the patients, by themselves, and by the FDA.

This is illustrative of the fact that the FDA, and by extension, the government, is responsible for the high cost of drugs- not the medical profession, and not Big Pharma.

   

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:

source*

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*