"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*

The Rush Limbaugh Factor

source*

You may hate Rush Limbaugh, and you wouldn't be the only one. But there is no doubt he is relevant in any discussion about the FDA.

For years, one of Limbaugh's main advertisers was Zicam, a homeopathic cold remedy. It was banned in 2009 by the FDA due to claims that it was causing anosmia, or loss of smell, in certain individuals.

Here is Limbaugh's shocked response to the ban from June 18, 2009:

"It's very deceitful, this Zicam stuff, folks, someday I'm going to be able to tell you the truth about this. What the FDA did yesterday regarding Zicam is unprecedented. The FDA has never done before what it did yesterday. This is a company being targeted for, let's face it, obvious reasons."

Again, you may hate Limbaugh. But that does not mean there is no truth to any of his claims. Yesterday, I mentioned that the FDA has not flinched from alarming the public in cases where its reputation was not at stake. I think the Zicam episode is a perfect example.

There are myriad drugs on the market that are homeopathic and, no doubt, very weird. But they are out there and being marketed without FDA approval. Even pepper spray is sold without FDA approval.

All I am saying is, if I want to spritz Zicam up my nose, I should have the right to do so. I am also saying that the FDA putting the kibosh on Zicam was purely political. 

The FDA is one of many government bureaucracies that Limbaugh has taken swipes at, and I think they wanted revenge and found their target in Zicam. 

source*

I would love to hear your thoughts on this. Do you think the FDA was justified? Do you miss Zicam? More importantly, are you comfortable with the idea of the FDA having the power to summarily pluck homeopathic remedies off of pharmacy shelves?

Or maybe you just think he deserved it. source*

                                                                  

"You Got Us"

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That was the blithe response of Chinna Pamidi, the president of Cetero Research, when the FDA discovered  the "'egregious' and pervasive" violations of a lab that had conducted research for the FDA and drug companies worldwide.

Good on the FDA. They caught the bad guys. But then what? According to this Scientific American article, virtually nothing.

To sum up the article, the FDA discovered back in May 2010 that Cetero Research had been presenting fraudulent research. This meant that many FDA-approved drugs were and are based on fake findings. Which unfortunately means the FDA label for an unknown number of unknown drugs is essentially worthless.

That is a bold statement, which is probably why the FDA chose not to disclose this tidbit of information in the "News and Events" section of their website. To this day, three years after their discovery, they still have not released the names of the drugs that are approved based on fraudulent research.

As the FDA claimed, this does not necessarily mean the drugs are dangerous. I would assume they are not, considering that whatever those drugs are, they are currently on the market and there have not been any undue drug-related disasters.

What it does mean, as SA pointed out, is that the "FDA's scientific basis for approving drugs has been undermined". Which leads me to question whether it is even necessary.

The FDA withheld information from the public for three years, and is still doing it, all because they claim they did not want to alarm the public. But the FDA has not flinched from alarming the public in other instances when their reputation would not be tarnished.

Protecting our health... or themselves? source*

                                         


Is the FDA tacitly admitting that a lot of their testing is not strictly necessary? Scientific American seems upset that the FDA did not regulate thoroughly enough. My question is, do they need to?

Feeling the Pain of Generic OxyContin

 
 So this happened:


   

The more I read about the FDA, the more I realize how similar it is to the Supreme Court of the United States. A select group of unelected individuals make sweeping decisions that affect the lives of millions of people, and can literally destroy companies. Or, in the case of Purdue Pharma, boost their stock considerably in a tough market.

Like in the Martha Stewart case, the New York Stock Exchange has been anxiously waiting for the FDA's verdict on a drug in recent weeks. In the last few years, OxyContin (a painkiller) has been reformulated to make it more difficult to crush and therefore more difficult to abuse. This "new" version of OxyContin has been approved, but several drug companies lined up to produce versions of the "old" OxyContin. FDA officials decided not to approve generic OxyContin, explaining that they are unnecessarily risky (even though, until recently, the FDA-approved version of OxyContin was virtually identical to these generic versions).

Let's talk brass tacks. The FDA's refusal to approve drugs that until a short while ago were perfectly legal has resulted in a windfall for the OxyContin company, and will damage the companies that were simply producing a legal, FDA-approved drug.

Is the FDA being protective or hypocritical? No matter how you look at it, this is another example of the FDA's far-reaching impact in our economy as well as our health. As the Wall Street Journal put it,
 
"The FDA's ruling, stating that original OxyContin was removed for "reasons of safety or effectiveness," means that generic versions of the drug can't come to market. The decision was applauded by some proponents of the new technologies. "This could've gone either way. It could've killed the market or it could have created a market boom. Fortunately, it was the latter," said Michael C. Barnes, executive director of the Center for Lawful Access and Abuse Deterrence.
 
Generic manufacturers argued that blocking them from making cheaper OxyContin would hurt patient access. OxyContin, on average, costs about $7.50 per pill, but generics would be at least 30% cheaper, analysts said.

The FDA—which had been under pressure from lawmakers to take action— said it wanted to balance the risks of allowing original versions of OxyContin, with the benefit of having lower-priced generics available.

On May 10, the FDA faces a similar decision on the efficacy of the abuse-deterrent features implemented with Endo's Opana drug."

I said before that the FDA is similar to the Supreme Court. In reality, it may be just as powerful, but it is far less representative and accountable to the American people. We don't know who decides at the FDA, or the details of those decisions. Michael Barnes' statement that the FDA could have killed a market or created a boom based on one decision is chilling. What do you think about the FDA's influence on market trends? In my opinion, it is an invitation to corruption.