[Jaye]

Some e-mail correspondence that i thought folks would like to see. The individual at PAN gave me permission to post her e-mails. The "Update on Sinemet" link below has a number to call if you got caught up in the shortage--they want to hear your story.

On Mar 31, 2011, at 10:52 AM, Elizabeth Kwasnik wrote:

Hi [Jaye],

Thank you for participating in the PAN Forum Webcast, and for submitting a question. While we were unable to ask all of the questions on the live webcast, we still want to answer any and all questions we received.

You asked about the Sinemet shortage and what can be done to help those who need the brand name and not the generic. In early March, the FDA approved a second manufacturer for Sinemet- Mylan- since Merck was experiencing a shortage.

The National Parkinson Foundation (NPF) posted a great update about the shortage on their website:

Update on Sinemet Shortage

I apologize that this was not a timely response; things were a bit hectic in the office after the Forum and we’re trying to tie up all loose ends. I hope that helps answer your question. Please feel free to contact PAN with any further questions.

Best,

Elizabeth Kwasnik
[etc.]

I wrote back...

Thank you very much! I had also called [my insurance company's preferred] online pharmacy and, after talking politely with them for two months AND having to take generic for a while AND the wrong dose for a while, I had to be quite direct with a couple of pharmacists. An advocate's work is never done, I've noticed.

If you have another couple of minutes, I would like to receive your permission to post your email on Neurotalk, please. If PAN spoke with the FDA about the problem, I would be glad to know that, too.. Thanks again for your communication.

Jaye ___ _____

and quickly received a reply.

Absolutely, feel free to share my email on Neurotalk. As far as I know, PAN was not in touch with the FDA directly. I know that our CEO, Amy Comstock Rick, did attempt to contact Merck to find out the details of the shortage and what was being done to alleviate it, but I’m not sure about the specifics of their communication.

Best,

Elizabeth Kwasnik
[etc.]

Maybe you'd like to tell your story here, too.

Jaye

[Bob Dawson]

I suggest that anyone wanting to look in detail at the frustration of the sinemet shortage (if in fact there ever was one – lots of pills disappeared from shelves and showed up for sale on the internet) should read over two previous threads – the one that starts in Canada but ends up in Spain: http://neurotalk.psychcentral.com/thread113354.html
And the one that follows it, in the U.K: http://neurotalk.psychcentral.com/thread129198.html

Futile endeavor for PWP; Big victory for Pharma - they demonstrated that all they have to do is stonewall and reveal nothing; they demonstrated that Merck is in 81 countries and PWP orgs are local; they demonstrated that they can play one country against another, and divert pills from one country to another with a system of triage we are not allowed to know about; they demonstrated that they can run a shortage for 3 years (2009, 2010, 2011), shifting from country with the U.S.A. last, and never explain why they shut down the old factory 3 years before opening a new one; and they demonstrated that the customer, the patient, has no connection with them at all; when they decided to change suppliers, while insisting it had nothing to do with quality; it is very hard to believe that the interests of Parkies were anywhere or at any time taken into consideration. When you get millions of people around the world addicted to a drug, and for half a century it remains the only drug, there should be some sort of legal and moral obligation on the part of the drug dealers to keep that supply coming into the 'hood.
Merck also demonstrated fierce and nasty sense of humour, for example in the letters to Australia, where they say, "Hey look, if you don't like this, call up your doctor and tell him to find some alternative treatment for you,"
AHhhhh, yes, the alternative treatments for Parkinson's! Be hard to choose - there are just so many other treatments to choose from - and oh, Merck? Thanks a lot for telling 5 million PWP to call their neurologist. In normal times in Quebec, it takes 4 to 6 months to get a 10 to 15 minute appointment with a neuro - that's in normal times. It gets worse if one of the largest Pharma companies in the world tells millions of PWP "Don't call us!! Call your neuro!" For weeks, you could not even get voice mail - you just got a busy signal. Must have been good for a few laughs. "What did you tell them? I told them if they don't like it, they can choose another treatment!."
Merck showed the Pharma industry how it is done, and Merck's public relations department sure earned that bonus.

[Jaye]

Ah, Merck, the company that brought us Vioxx under the medical director that then moved to Amgen. I read about it in a big finance magazine.

Ah, Amgen, the company that brought us the drama of GDNF. I saw it on 60 Minutes.

OK, now who is Mylan and who owns them and thank you, Mylan, for leaping into the breach. Now can I have some that doesn't crumble into little shiny crumbs in my small, sealed medicine box...yeah...I had some yesterday...where is it...

And yeah, what about human rights and the powers who favor them or fight them!

Must...not...get...stressed...must...relax...take meds...must call doctor... ... ... ...

[ol'cs]

The massive amounts of L-Dopa that America consumes, comes from the chemical "stating material", Vanillin, by a short classic reaction sequence involving "asymmetric hydrogenation". It is the Vanillin that is obtained by steam distillation of Vanilla pods, grown in the tropics, that is the "commodity" that controls L-Dopa production and supply. If there was ever a shortage problem, there are other semi-synthetic routes to L-Dopa that would be put into immediate use, using guiacol or other intermediates to make the ton quantities of our "gold standard" drug. Dopa supply should be stable for as long as their are people like us who need it to live. cs

[lindylanka]

Originally Posted by ol'cs

The massive amounts of L-Dopa that America consumes, comes from the chemical "stating material", Vanillin, by a short classic reaction sequence involving "asymmetric hydrogenation". It is the Vanillin that is obtained by steam distillation of Vanilla pods, grown in the tropics, that is the "commodity" that controls L-Dopa production and supply. If there was ever a shortage problem, there are other semi-synthetic routes to L-Dopa that would be put into immediate use, using guiacol or other intermediates to make the ton quantities of our "gold standard" drug. Dopa supply should be stable for as long as their are people like us who need it to live. cs

Dear CS,
Could you translate this into easy language for us. are you saying that our meds are synthesized from vanilla pods! Not velvet bean?

Please clarify....

Lindy

[Bob Dawson]

If anyone gets new information about the shortage of Merck labels on sinemet containers (I have never seen any evidence that world production declined, just that the labels changed), I would appreciate being notified by e-mail from this site, or I could give my address to a few. I will be away a lot, so I may not see what anyone posts here. The shortage in the USA was the shortest - announced on Dec. 24 when all are on holidays, then Merck told the FDA the shortage was over, the day after getting a call from CBS News.

But the shortage of Merck labels continues in some European countries, where Switzerland, for example, switched to Sandoz as supplier, and the Swiss PD advocacy org. finally removed the logos of the Pharma companies that graciously pay for the advocacy newsletter... no word at all from the Third World, except one man in Kenya who said sinemet had disappeared entirely, and he was buying from one of the hundreds of sinemet websites that popped up on the internet since Merck announced the shortage in 2009.

I never viewed this "shortage" and "generic or not generic" story as carrying much weight. Much more serious crimes and misdemeanors are approved in Pharma boardrooms on a regular basis, and this "production problem" was probably a result of entrenched incompetence and management negligence, more that a burning desire to see just how crooked a company can get - as they say "It's no fun just to win, you've got to win dirty". The purpose of challenging them was to see how the various systems would react, because they will use the same process in the future, as it works very well for them. AmgenGDNF, and Merck's Shortage .- handled in similar ways
That's why I tried to attract attention to the sinemet label disappearance. We got to see how Pharma handled it, how governments handled it, how the associations of neurologists and associations of pharmacists dealt with it, how Parkinson's Chat rooms dealt with it, and what was the place of the actual Parkinson's people or at least some consideration of their needs, when the second largest drug dealer in the world announces that they have closed down one production line two and a half years before opening a new one,for reasons that we are forbidden to know.
I intend at some point to write a brief summary of the patterns of reaction, maybe this summer if Merck runs out of countries to announce a shortage in; - what you can expect the reactions to be next time; so the next PWP to enter the Inferno will be better able to predict the charade that will be presented to them.
In any case, the Baby Boomers are on their way, millions of new PD cases around the world, so you will eventually see some radical changes, as the existing PD system is in no way ready for them; and because they are going to be in for a shock when they have a closer look at the wildly dysfunctional Parkinson's Empire that has grown up around their disease; they will reclaim ownership of the disease, and they will expect the vendor to have certain responsibilities toward the purchaser, such as, the vendor should actually deliver the drug that they got millions of people addicted to. They can have their billions - I don't care about the money. But there are some people out there - for example the PD org in the UK followed a few cases of PWP ending up in emergency wards after days of searching for sinemet - there are people out there who will not be willing to be treated this way, or to watch their loved ones being treated this way, by a contractor who is supposed to be helping them.

[ol'cs]

Semisynthetic vanillin is made in ton quantities from lignin from forestry waste. I don't know if they have a "greener" route to l-dopa by using highly enantiospecific "bugs" that have been bioengineered to produce l-dopa, but the big breakthrough that professor Knowles recieved the Nobel Prize in Chemistry in 2001, was for the Monsanto process which starts using synthetic Vanillin. The "asymmetric hydrogenation process" came about by using "chiral ligands" on the hydrogenation metal catalyst, which allowed the reduction of an achiral compound made from vanillin to give almost exclusively "l" dopa with no "d" dopa in it. This was revolutionary, but improvements in yield, purity, and the production giving less toxic waste, are occurring all the time.
Could be that something went wrong when a large batch was made and they had to start all over. But I wouldn't worry about sinemet shortages, it's an easy small molecule to make in ton quantities from cheap starting materials