Cycloserine is available, but is it accessible?
Kymberley Scroggie, Breaking Good
I’m a synthetic chemist, so usually I work in the chemistry lab making new medicines, but recently it's medicines that already exist that have been catching my attention.
Nearly all l of us will have taken medicine. Maybe it was a pain reliever to help ease a headache or, dare I say, an anesthetic to numb that gum when you visited the dentist. Remember that one? Or maybe you don’t want to!
But, have you ever wondered why we have access to all these medicines? Who provides them to us? Why are some more accessible than others? And, why does their accessibility sometimes fluctuate? I’ve been asking myself these questions lately and so have the team at Breaking Good.
I realised that the answers to these questions would be different for each medicine. So, I set out to investigate cycloserine, a medicine used to treat multi-drug resistant tuberculosis (MDR-TB), one of the diseases I’d normally be working on to find new medicines for in the lab.
Cycloserine has been sold under the trade name Seromycin since 1964
As luck would have it, cycloserine is an essential medicine and I was able to start my investigation by searching the E$$ENTIAL MEDICINE$ database. This public database compiles information on medicine trade names, the date the FDA approved their use, and the companies that are currently able to supply the medicine to the USA.
Big shout out to all those who helped build and contributed to this database! From it I found out that cycloserine is currently being sold under the trade name Seromycin with rights (ownership) to it being held by Purdue GMP Center Inc.
I also learnt that cycloserine was first approved by the FDA all the way back in 1964 and that even though it is no longer protected by a patent or exclusivity agreement , no generic versions are currently available.
As is often the case, in finding answers I created more questions. I now wondered if Purdue GMP Center Inc had always held the rights to Seromycin. Were they the ones that applied for approval from the FDA in 1964? To find out more, I turned to Google and conducted a search for ‘seromycin purdue’.
Eli Lilly and Company transferred the rights to Seromycin
The first search result from my Google search was a news article about increasing the shelf life of Seromycin (Purdue University, 2013). Interesting, but not really related to what I’m trying to find out.
The second search result was more promising. Ownership was specifically mentioned in the short preview of text and the source is the Purdue website. It was a news article containing information on multi-drug resistance tuberculosis, the disease that Seromycin is used to treat (Purdue University, 2008).
I’d hit the jackpot! This source provided me with a few more pieces to the puzzle and again answered some of my questions but also created even more new ones.
So settle yourselves in - I was in for a long one!
I found out that Eli Lilly and Co previously owned the rights to Seromycin, transferring them to The Chao Center for Industrial Pharmacy and Contract Manufacturing as part of a philanthropic initiative to fight multi-drug resistant tuberculosis.
From this source I also learnt that The Chao Center was owned by the Purdue Research Foundation and that its aim was to train students in current Good Manufacturing Practice abbreviated to cGMP. A few things were looking awfully familiar and I was beginning to think that The Chao Center might be linked to Purdue GMP Center Inc who currently has ownership of Seromycin.
To confirm my suspicions, I did a second Google search, this time for ‘Purdue GMP Center’ hoping to find a link to The Chao Center. First up was another news article from the Purdue website titled ‘Pruder GMP Center now operates as Parsolex…’ (Purdue University, 2019).
Curious! Very curious. I opened the link.
The Chao Center is Purdue GMP Center is Parsolex
This article begins with the statement that ‘Purdue GMP Center Inc is now operating as Parsolex GMP Center Inc doing business as Parsolex’ and is dated October 19, 2019. Another piece in the puzzle! It also confirmed my previous suspicion, mentioning that the company started operations in 2005 as The Chao Center.
The article made no comment, however, on the move from The Chao Center to Purdue GMP Center Inc. Looking back at the Google search results for ‘Purdue GMP Center’ I quickly scanned through looking for anything that might give me some more details. BINGO!
Towards the bottom of page 1 there was a result titled ‘Chao Center becomes PGC, now open for business’. Published on June 29, 2017 this news article detailed the rebranding of The Chao Center to Purdue GMP Center Inc (Veleta, 2017).
Adding this piece to the puzzle, I compiled all the information I’d found so far. I knew that Eli Lilly and Co transferred the ownership rights to The Chao Center, whose name changed in 2017 to Purdue GMP Center Inc and then again in 2019 when it became Parsolex GMP Center Inc.
But, I still didn’t know when Eli Lilly and Co had given The Chao Center the ownership rights to Seromycin or anything about Seromycin’s life before this time and I wanted to know. To find out, I returned to trusty old Google.
‘Lilly produced Seromycin for five decades…’
I’d scanned further down the list of results from my initial Google search for ‘seromycin purdue’ before I spotted another one about Eli Lilly and Co transferring the rights of Seromycin to Purdue (Kaiser Health News, 2009) I opened the link looking for answers to my burning questions. It was published on Thursday June 11, 2009 and detailed an announcement made the previous Tuesday about the transfer in ownership. Excellent, one of my questions was answered!
As I kept reading I stumbled upon another lead,
‘Lilly produced Seromycin for five decades…’
Fantastic! I knew from the public database that the FDA approved Seromycin in 1964. If Eli Lilly and Co had been making Seromycin for 50 years, they might have been the ones who first sought FDA approval and have held the rights to Seromycin since it was first approved.
I decided to search a trademark website for Seromycin. Maybe it would be able to tell me some more about the ownership history. There were two Seromycin trademarks though neither lead to any additional information that I hadn’t already discovered. Rubbish!
Changing tact, I did yet another Google search, this time using the key words Seromycin, Eli Lilly and Co, FDA and 1964. I put 1964 in quotation marks so that Google would only bring back results that included 1964. This time I didn’t find any one single source that gave solid confirmation that Eli Lilly and Co were indeed those who first owned Seromycin, but there seemed to be a consensus between a number of websites that they were the ones who owned Seromycin and got approval for it from the FDA in 1964 (Young, 2015; Tomlinson, 2011).
Price increase from 480 USD to 10,800 USD for a 30 pill packet
During my investigation into cycloserine, there were a few results with titles related to price increases. These piqued my interest!
In the case of cycloserine, it turns out that Rodelis Therapeutics acquired the rights to Seromycin from The Chao Center in 2015 and with plans to increase the price from 480 USD to 10,800 USD for a 30 pill packet. When The Chao Center learnt of this they interjected and asked for the rights back saying it was ‘not what they had intended’. Thankfully, Rodelis therapeutics agreed and the rights were returned to The Chao Center swiftly and the price reduced (Seidman, 2015; Pollack, 2015).
I was convinced that cycloserine was an easily accessible medicine, after all it had been available since 1964. But if medicines are available, yet cost an arm and a leg, are they really accessible?? We would argue no.
That’s why we initiated E$$ENTIAL MEDICINE$ - a citizen project exploring the world's most important medicines. Through E$$ENTIAL MEDICINE$ we hope to gain a better understanding about the accessibility of essential medicines and why and how this changes over time. Our new installment of E$$ENTIAL MEDICINE$ invites you to follow a process similar to the one you’ve just read, and is now open for contributions!
To participate in this research you can get started here. Keep up to date with what we discover, and join our conversation here.
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Kaiser Health News. (2009). Eli Lilly Transfers MDR-TB Drug Rights to Purdue University. KHN Morning Briefing. https://khn.org/morning-breakout/dr00049357/
Pollack, A. (2015, September 21). Big Price Increase for Tuberculosis Drug Is Rescinded. The New York Times. https://www.nytimes.com/2015/09/22/business/big-price-increase-for-tb-drug-is-rescinded.html
Purdue University. (2008). The Enduring Burden of Tuberculosis. News. https://www.purdue.edu/uns/x/2008a/080331O-KissingerVoices.html
Purdue University. (2013). Blister packs increase shelf life of multidrug-resistant tuberculosis medicine—Purdue University. Purdue Today.
https://www.purdue.edu/newsroom/releases/2013/Q3/blister-packs-increase-shelf-life-of-multidrug-resistant-tuberculosis-medicine.html
Purdue University. (2019). Purdue GMP Center now operates as Parsolex and is expanding capabilities.Research Foundation News.
https://www.purdue.edu/newsroom/releases/2019/Q4/purdue-gmp-center-now-operates-as-parsolex-and-is-expanding-capabilities.html
Seidman, B. (2015). Huge price surge for another old drug called off. CBS News. https://www.cbsnews.com/news/huge-price-surge-for-another-old-drug-called-off/
Tomlinson, C. (2011). Cycloserine. TB Online. http://www.tbonline.info/posts/2011/8/24/cycloserine/
Young, M. (2015). So what are the real costs of drugs today? Moxafrica. https://www.moxafrica.org/post/2015/09/24/so-what-are-the-real-costs-of-drugs-today