The History of the World, My Sweet-- Is Who Gets Eaten, and Who Gets to Eat!

Just to avoid confusion, from now on I'm going to put the name of the author at the top of each post. I wouldn't want you to think I'm as prolific as Norman! -- AWO

by Norman Horowitz

This post's title is a quote from the brilliant Stephen Sondheim play Sweeney Todd: The Demon Barber of Fleet Street.

As a studio motion picture and television salesman, it was my responsibility to extract as much money from those buying such content as possible without cheating and lying in the process. Conversely, those buying the content were trying as hard as they could to pay as little as possible for it.

Here's a confession, or at least an acknowledgement as to a relevant point in the process: For the majority of the motion pictures or television product, there is little to distinguish the value of the available content. It was mostly in the minds of the buyers, placed there whenever possible by the sellers like me.  

For many decades, there were times when the feds interceded to prevent the studios from extorting money from the theater and broadcast owners (but details about that that are for another time). I extorted money (not really) when I controlled content that more than one broadcaster wanted. It was my job.

I played in a commercial, victimless game of producing, buying, and selling programming. My managements were never pleased by my considering it a game, yet that is what it was.

I'm not an expert in the legalities, but I've been an expert in creating euphemistic opportunities of turning film buyers upside-down so that I could get the remaining loose change from their pockets after I had taken all of their bills.

So I may not be an investigative reporter, but I know a thing or two about taking people's money. Keep that in mind for the following story.

For about ten years, I've suffered from gout. Everyday I've taken a prescription called "colchicine." :

[Colchicine] was sold as a generic in the United States for many years. In 2009, the FDA approved colchicine for gout flares, awarding Colcrys a three-year term of market exclusivity, prohibiting generic sales, and increasing the price of the drug from $0.09 to $4.85 per pill.

[They may have had a valid reason for doing this, but I doubt it.]

Numerous consensus guidelines, and previous randomized controlled trials, concluded that colchicines is effective for acute flares of gouty arthritis. However, as of 2006, the drug was not formally approved by the FDA, owing to the lack of a conclusive randomized control trial (RCT). That year the FDA started their Unapproved Drugs Initiative, through which they sought more rigorous testing of efficacy and safety of colchicine and other unapproved drugs on the market. In exchange for paying for the costly testing, the FDA gave URL Pharma 3 years market exclusivity for its Colcrys brand, under the Waxman-Hatch Act, based in part on URL-funded research in 2007, including pharmacokinetic studies and RCT with 185 patients with acute gout. URL Pharma also got 7 years market exclusivity for Colcrys in treatment of familial Mediterranean fever, under the orphan drug act. URL Pharma raised the price from $0.09 per pill to $4.85, and sued to remove other versions from market. This will increase costs to state Medicaid programs from $1 million to $50 million.

April 2010 : In a critical editorial in the New England Journal of Medicine (NEJM), Kesselheim and Solomon said that the rewards of this legislation are not calibrated to the quality or value of information produced. There is no evidence of meaningful improvement to public health. It would be much less expensive for the FDA or NIH to pay for trials themselves on widely available drugs such as colchicine. The burden falls primarily on patients or their insurers. URL Pharma posted a detailed rebuttal of the NEJM editorial.

Sept 2010: FDA orders halt to marketing of unapproved single-ingredient oral colchicine.

The cost for treating the gout that I have been gifted with has risen from under $3 per month to about $150 per month.

I would like to suggest that the feds or someone investigate this mess and, if called for, send a few to prison.

It seems to me that it's okay to sell a James Bond movie for as much as possible, but for the feds to be complicit with a drug company in increasing the price of a drug so dramatically is not okay.

My daughter Eileen lives in France and is able to purchase colchicine for about 8 cents a tablet. I gather that this is the price for the product everywhere but here!

Never, never, never forget: "The history of the world, my sweet-- Is who gets eaten, and who gets to eat!"