Fiction influences reality: Quincy M.E.'s role in the Orphan Drug Act
February 8, 2015 6:40 AM Subscribe
How Quincy M.E. Changed American Law and Saved Lives discusses the serendipitous way that a young man's need for medication for Tourette's syndrome came to the attention of a family member of actor Jack Klugman and resulted in the Orphan Drug Act of 1983.
(main article by MeFi's own Garius)
Between 1983 and 2010, the Orphan Drug Act has had a role in the approval by the FDA of 353 drugs for the treatment of diseases affecting less than 200,000 people. The ODA reduces the financial burden of researching medications for diseases that would otherwise be unprofitable for pharmaceutical companies through tax incentives, patent protection, research subsidies, and the creation government-sponsored institutions.
For information about diseases and treatments in the FDA's OOPD
Between 1983 and 2010, the Orphan Drug Act has had a role in the approval by the FDA of 353 drugs for the treatment of diseases affecting less than 200,000 people. The ODA reduces the financial burden of researching medications for diseases that would otherwise be unprofitable for pharmaceutical companies through tax incentives, patent protection, research subsidies, and the creation government-sponsored institutions.
For information about diseases and treatments in the FDA's OOPD
The Orphan Drug Act made it possible to keep my wife ambulatory. That being said, here's an example of unintended consequences.
posted by infinitewindow at 7:12 AM on February 8, 2015 [1 favorite]
posted by infinitewindow at 7:12 AM on February 8, 2015 [1 favorite]
That article appears to be subscriber-only, infinitewindow. Can you sum it up for us?
posted by Etrigan at 7:24 AM on February 8, 2015 [1 favorite]
posted by Etrigan at 7:24 AM on February 8, 2015 [1 favorite]
Great story, Klugman always seemed like such a cool guy. Also, why am I not surprised that Republicans tried to block the bill?
posted by octothorpe at 7:25 AM on February 8, 2015
posted by octothorpe at 7:25 AM on February 8, 2015
They didn't even try to block it, just use it to get more taxpayer money for their buddies. Small government, ya know.
posted by Potomac Avenue at 7:27 AM on February 8, 2015
posted by Potomac Avenue at 7:27 AM on February 8, 2015
huh, weird, it wasn't subscriber-only going directly from Google.
Basically there was a gout drug used since ancient times that was available until 2009 for $0.09 per dose. A company applied for orphan status for an unrelated condition, received exclusive marketing for the drug from the FDA under the ODA, raised the price to $5 per dose in the US and shut down generic production.
posted by infinitewindow at 7:30 AM on February 8, 2015 [5 favorites]
Basically there was a gout drug used since ancient times that was available until 2009 for $0.09 per dose. A company applied for orphan status for an unrelated condition, received exclusive marketing for the drug from the FDA under the ODA, raised the price to $5 per dose in the US and shut down generic production.
posted by infinitewindow at 7:30 AM on February 8, 2015 [5 favorites]
There are always unintended consequences and gaming of the system but, to my mind, this is the way government is supposed to work - consciously promoting the general welfare.
posted by Benny Andajetz at 7:42 AM on February 8, 2015
posted by Benny Andajetz at 7:42 AM on February 8, 2015
I love this article. Great stuff!
posted by Potomac Avenue at 8:18 AM on February 8, 2015
posted by Potomac Avenue at 8:18 AM on February 8, 2015
Great story, Klugman always seemed like such a cool guy.
All the research/reading I've done on him suggests he was a great guy to know, but an absolute bastard to work for/with on Quincy.
There can't be many actors who've managed to get both Glen A. Larson and Donald P. Bellisario booted off of their show.
posted by garius at 8:33 AM on February 8, 2015 [2 favorites]
All the research/reading I've done on him suggests he was a great guy to know, but an absolute bastard to work for/with on Quincy.
There can't be many actors who've managed to get both Glen A. Larson and Donald P. Bellisario booted off of their show.
posted by garius at 8:33 AM on February 8, 2015 [2 favorites]
Mandatory Quincy theme song with lyrics link.
posted by benito.strauss at 8:52 AM on February 8, 2015 [5 favorites]
posted by benito.strauss at 8:52 AM on February 8, 2015 [5 favorites]
Equally mandatory highlight reel from the classic punk episode
posted by sphexish at 1:41 PM on February 8, 2015 [1 favorite]
posted by sphexish at 1:41 PM on February 8, 2015 [1 favorite]
There are always unintended consequences and gaming of the system but, to my mind, this is the way government is supposed to work - consciously promoting the general welfare.
Gout affects 1-2% of the Western population, and a drug that many sufferers take daily now costs around $1000 a year. It used to cost them around $30. That drug has been around for literally thousands of years; the drug company invested $100 million (half of which was a fee paid to the FDA) and got three years of marketing exclusivity. Over those three years, US Medicaid alone was forced to pay the company more than $150 million. The price appears to have halved since they lost marketing exclusivity; I have no idea why pharmacies are justified in charging more than $2.50 for something that cost $.09 only five years ago.
So. Tell me more about the general welfare.
posted by Joe in Australia at 2:40 PM on February 8, 2015 [1 favorite]
Gout affects 1-2% of the Western population, and a drug that many sufferers take daily now costs around $1000 a year. It used to cost them around $30. That drug has been around for literally thousands of years; the drug company invested $100 million (half of which was a fee paid to the FDA) and got three years of marketing exclusivity. Over those three years, US Medicaid alone was forced to pay the company more than $150 million. The price appears to have halved since they lost marketing exclusivity; I have no idea why pharmacies are justified in charging more than $2.50 for something that cost $.09 only five years ago.
So. Tell me more about the general welfare.
posted by Joe in Australia at 2:40 PM on February 8, 2015 [1 favorite]
There is no shortage of examples showing pharmaceutical companies being dicks. Or government screwing the pooch. But, trying to do the right thing counts, in my book. YMMV.
posted by Benny Andajetz at 2:54 PM on February 8, 2015
posted by Benny Andajetz at 2:54 PM on February 8, 2015
BTW, I'm an insulin-dependent diabetic who knows from ridiculously inflated prescription costs.
posted by Benny Andajetz at 2:56 PM on February 8, 2015
posted by Benny Andajetz at 2:56 PM on February 8, 2015
That is really fascinating! Enjoyable read. Just the other day I started putting on Quincy, M.E. while I work on stuff - the few episodes I've seen seem to highlight how far medical ethics have come in the last 35 years, but maybe I'm just looking at this the wrong way (the last one I saw had him give a guy horrible heartburn and tell him he was dying of a heart attack to get him to confess to a crime).
But yeah, as far as general welfare goes, it's not like one bad example completely undermines an entire program. I wasn't able to read the gout article, so I can't comment any more specifically than that.
posted by teponaztli at 3:36 PM on February 8, 2015
But yeah, as far as general welfare goes, it's not like one bad example completely undermines an entire program. I wasn't able to read the gout article, so I can't comment any more specifically than that.
posted by teponaztli at 3:36 PM on February 8, 2015
slight derail: to look at the article from my first comment, copy the link and paste it into Google search. Clicking the link from Google will let you read it if you like. </derail>
posted by infinitewindow at 4:40 PM on February 8, 2015 [2 favorites]
posted by infinitewindow at 4:40 PM on February 8, 2015 [2 favorites]
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