replying so the total posts will be 100 lol (Good thread - bueno)
Peg

I take 3 drugs all day every day: sinemet, selegiline, and Mirapex.
We have, in the thread above, managed to get a tiny glimpse of the "production problems" of the sinemet markets; and the inevitable "world-wide shortage" that resulted from synchronized shutting down of production in different companies in different countries, although we have only heard from about 5 of the 140 countries affected.
Kate Kelsall at Shake, Rattle and Roll <http://katekelsall.typepad.com/> sends ominous information. The "world-wide" shortage of sinemet, is now being assisted by the closing down of some formats of selegiline as well. But it is "nation-wide", not "world-wide".
Just a co-incidence folks. Nothing to see here. Move along. You've still got your Mirapex. One out of three ain't bad. And the selegiline shortage applies only to the capsules, not to the tablets. So it should be no problem. Except it would be nice to know more.... production of drugs for Parkies has been shutting down in one format after another, in one factory after another, in one country after another, for one drug after another, since June of 2009. And we hear nothing, we know nothing, other than these form letters -- note that Kaiser was the first to write to the actual patients; the complete disappearance of Merck sinemet in some countries, such as Australia, was signaled to doctors and chemists only. And nobody was told in Kenya; the drugs just suddenly disappeared. Hear much from the World Health Organisation recently? Me neither.

KAISER PERMANENTE
January 14, 2010
To: Kathleen Kesall
(address deleted here - but it is our Kate from Shake, Rattle and Roll)

Dear Kathleen Kelsall,
Our pharmacy records show that you recently received a prescription for selegiline 5-Mg tablets. This drug is used to treat Parkinson's disease and mood disorders. If you are no longer taking this medication, or are no longer a Kaiser Permanente member, please disregard this letter.

We want you to know that there is a national shortage (not enough drugs for all patients) of selegiline 5-mg tablets. The reason for the shortage is because the drug company that makes selegiline tablet has stopped making the tablet. At this time we are expecting that the company will make the tablet again in the future.

Kaiser Permanente pharmacies will run out off selegiline 5-mg tablets by the end of January 2010. We do not know when the company that makes selegiline tablets will be able to make more, but expect that the shortage will last many months. Until the tablets can be used again, there is a capsule form of selegiline 5 -mg that will give you the same drug at the same dose. Your doctor has approved a change from selegiline tablets capsules.

What do I need to do?
-- when you need to refill, order a refill as you normally would. Because your prescription has been changed, you will receive capsules instead of the tablets on one of your next refills
-- the directions will be the same for the new selegiline capsules as they were for the tablets
-- do NOT use selegiline 5-mg tablets and selegiline 5 -mg capsules at the SAME TIME. Use your remaining selegiline tablets as you normally do until they're gone. THEN start using your new selegiline capsules.

If you have any concerns or questions related to this drug shortage, please contact that Clinical Pharmacy Call Center at 303-338-4434, Monday through Friday, 8 a.m. to 6 p.m. The TTY number for the deaf and hard of hearing is 303-338-4428.

Sincerely,
Kersten Froyd, MD

BD: My comment: I would consider this to be entirely innocent, if it were not for the huge disappearance of sinemet around the world at exactly the same time. We, the Parkies, spend $3billion a year world-wide on these drugs. In any other industry we would not have to search for the most basic info. If we were buying $3billion a year of chocolate bars, Hershey, Mars, Nestle, etc. would be falling over each other to satsify the requirements we impose on them. With drugs that we need to be able to walk down the street or hold a spoon, we get zero info and have zero input and are treated as if we are brain-damaged and expendable.
And still I want to know: the timeline of the shutting down of production, and the triage system as it applies around the world. Canada somehow bought its way out of the sinemet crisis despite shutting down its own production and importing from other countries... but in Kenya, the supply of drugs disappeared entirely, according to a Parkie in Nairobi, who wrote to me, saying he had been told the shortage existed only in Africa.
Well the shortage exists in most countries of the world, except Canada and the U.S.A., and of course Spain, where a small Parkie group proposed jail time and the production problems, which were supposed to last for a year or two, were suddenly resolved in a few days.
I get my drugs okay, I am happy to be protected in this way, but in other countries Parkies in panic are buying in the fast-growing black market; or, they are just going without, and every time I swallow a sinemet tablet, it tastes like blood.

Thanks, Bob, for letting us know.
If there are others who can help draw a clearer picture of PD drug distribution around the world please let us know. It is starting to feel like the cake is being sliced in very large slices withe few leftovers.....

Lindy

Failed to get any information from the other 135 countries where there is or maybe there is not a "world-wide shortage" of whatever.
I have no idea if the situation described below relates in any way to the real shortage or make-believe shortage of the drugs some of us need to be able to function, but its does indicate that some of these people are living in a hell of their own making:

March 5, 2010
Moody's Upgrades Mylan
Third such positive action from independent third party in the last year
PITTSBURGH, March 5, Mylan Inc. (Nasdaq: MYL) today reported that Moody's Investors Service upgraded the company's credit ratings…
…Currently, Mylan has 142 ANDAs pending FDA approval representing $93.8 billion in annual brand sales, according to IMS Health…
…In 2000, the company agreed to pay $147 million to settle accusations by the F.T.C. that they had raised the price of generic lorazepam by 2600% and generic clorazepate by 3200%. Mylan obtained exclusive licensing agreements, in 1998, for certain ingredients. The company did not admit to any wrongdoing….
Mylan Receives FDA Approval for Generic Version of Parkinson's Treatment Sinemet(R)
30 Sep 2009
Carbidopa and Levodopa Tablets approved today...
Mylan Inc today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the FDA for its Carbidopa and Levodopa Tablets the generic version of Bristol Myers Squibb's Parkinson's treatment Sinemet®,
"What Is Wrong Inside The Company?"
By Jim Edwards | Sep 9, 2009
David Moskowitz downgraded the stock and asked in a note to investors, “What is wrong inside the company“?..
Limited visibility on why these departures took place gives us pause regarding the senior leadership team at Mylan, and until another CFO is appointed and assessed, we believe investors will continue to wonder what is wrong inside the company…
Here’s the couldn’t-be-worse timeline of events at the company:
May
Jolene Varney hired as CFO.
July
Pittsburgh Post-Gazette publishes story based on leaked documents about workers overriding computer safety procedures at a Mylan plant. Mylan vehemently denies the story. The FDA ultimately clears the plant for business.
August
Mylan files lawsuit stating that it has conducted an internal investigation to find a mole who leaked the report to Pittsburgh Post-Gazette.
September
CFO Varney exits.
Mylan Inc’s subsidiary Mylan Pharmaceuticals sued the Post-Gazette and two of its journalists, claiming that the paper and its reporters improperly obtained confidential documents and misappropriated trade secrets in the process of reporting and publishing a story on an internal company report about potential problems at Mylan’s Morgantown, West Virginia, plant.
The Post-Gazette’s article on the content of Mylan’s internal report was meticulously accurate,” one court filing said. “Indeed, Mylan concedes as much, since the complaint contains no cause of action alleging falsity or any other alleged wrong regarding the publication.”
In a motion to dismiss the lawsuit, the Post-Gazette accuses the company of ulterior motives, saying that it doesn’t want to hold the newspaper liable but rather find out who among its employees served as sources for the article.
It says that Mylan “undertook a feverish hunt” to find those sources to no avail.
The Post-Gazette wrote in its filing that Mylan’s effort to circumvent the Constitution “is doomed to fail.”
Mylan's share price fell sharply after the Post-Gazette's initial report that workers had overridden controls intended to ensure the safety and efficacy of prescription drugs…
The report showed that over an extended period of time, employees had overridden computer-generated warnings about potential problems in the drug-making process.
Mylan became embroiled in litigation in the late 1990s over allegations that the company had attempted to corner the market on the raw materials used to make two anti-anxiety drugs, lorazepam and clorazepate. According to the Federal Trade Commission (FTC), which filed a suit against Mylan in December 1998, Mylan jacked up its prices on these drugs more than 3,000 percent after signing deals with its suppliers that allegedly locked out the firm's competitors… in July 2000, Mylan agreed to settle federal, state, and private lawsuits that were brought in connection with this matter. For the FTC, the $100 million that Mylan was required to pay the agency and 33 states was the largest monetary settlement in its history. ..It also agreed not to sign any more exclusive-supplier agreements. …
Mylan was also involved in a number of other lawsuits during this period and into the early 2000s. Most of the suits involved other pharmaceutical companies, specifically brand-name drug firms who were increasingly filing suits and using other delaying tactics in order to maintain their rights to the exclusive marketing of their proprietary drugs for as long as possible. In one of the most noteworthy such cases, Mylan sued both Bristol-Myers Squibb Company and the FDA in late 2000 in its effort to begin selling a generic version of BuSpar, an anti-anxiety drug.. Mylan later received $35 million in damages from Bristol-Myers as part of the settlement of lawsuits that had been brought against that company because of the tactics it had used to try to keep the generic version off the market.
Mylan Laboratories was positioned to be one of the main beneficiaries of this trend. One cloud on the company's horizon, however, was yet another lawsuit. In September 2003 the attorney general of Massachusetts filed suit against Mylan and 12 other pharmaceutical companies, accusing them of overcharging Medicaid plans as part of the practices they used to price generic drugs.

Bnet:
It's Not Mylan's First Quality Control Beef With FDA
By Jim Edwards | Jul 28, 2009
If you’re following Mylan’s fight with the FDA over whether the agency did or did not give the generic maker a clean bill of health at its Morgantown, W.Va., factory, you’ll be interested to know that this is not the first time the FDA has frowned upon the company.
Back story: The Pittsburgh Post-Gazette published a must-read story on Sunday detailing workers in Mylan’s drug factory overriding computer warnings designed to alert staff that the drugs they were making were faulty. Mylan denies anything’s wrong, but the Wsll Street Journal reports that the FDA is taking the report “very seriously.” Mylan has continued to insist that the FDA has given it the all-clear.
It turns out Mylan and the FDA have a little history between them. In March 2006 the FDA ordered a nationwide recall of Mylan’s Carbidopa and Levodopa extended-release tablets, citing this reason:
The incorrect stability test method was used to assure that the product meets its specifications throughout its shelf life.
Then, in 2008, the FDA moved to disqualify a doctor involved in research performed for Mylan on Nebivolol, a hypertension drug. The FDA:
… we believe that you have submitted false information to the sponsor or FDA in required reports and repeatedly or deliberately violated regulations governing the proper conduct of clinical studies involving investigational products
Here’s the tick-tock on the current fight:
• Sunday July 26, 2009: … according to a confidential internal report obtained by the Pittsburgh Post-Gazette, the company discovered that workers were routinely overriding computer-generated warnings about potential problems with the medications they were producing.These alerts, triggered during the making of tablets and capsules, warn production workers that the medications may fail to meet specifications for weight, thickness or hardness …
• Mylan responded later on July 26, 2009: “An article published today about an issue related to a Standard Operating Procedure (SOP) was based on improperly obtained documents, uninformed third-party commentary and anonymous sources. Simply put, our investigation of the issue demonstrates that our quality systems are working, not the contrary.
• Mylan then said on July 28, 2009: … the FDA visited the company’s Morgantown, W.Va., manufacturing facility Monday morning and has determined that the baseless accusations in the article were unfounded. The FDA noted there was no evidence of any data deletion.
• The FDA said on July 28: “This investigation involves allegations of compliance violations that the FDA takes very seriously. The investigation is on-going and the agency has formed no conclusions at this time. Statements to the contrary are untrue,” the FDA’s Assistant Commissioner for Compliance Policy, Office of Regulatory Affairs, said in a statement.
• Mylan said in response: … a Mylan spokesman told Dow Jones Newswires that “our CEO would never have gone out with a statement like that without being informed of the closeout of the FDA inspection.”
What’s really going on? Here’s a theory: Note that Mylan’s statement focuses on “data deletion,” but it’s not just data deletion that’s at issue.
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools.
Mylan’s new CFO has left the job after just three months. Her departure follows an (as-yet) unrelated manufacturing controversy at Mylan, and an internal probe to find the mole who leaked internal documents about safety procedures at Mylan to the press.

Are we having fun yet?

What I posted above is a mixture of short items, but it comes from following Jim Edwards blog on Pharma insight at Bnet. Jim is somebody you want to have around.:
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years. He is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. He has also won the Neal award for business journalism, an S.P.J. award for investigative journalism, and the N.J. Press Association's Public Service award.

http://search.bnet.com/index.php?q=Jim+Edwards

Mylan lawsuit against newspaper:
http://search.bnet.com/index.php?q=mylan

Mylan: what is wrong inside the company?
http://industry.bnet.com/pharma/1000...e-the-company/
or this:
http://industry.bnet.com/pharma/1000...ctor-perfector

60 Minutes anyone?

Bob, do you have a link for that piece you copy/pasted? It would be helpful to add that as we do not want to infringe possible copyright. If you are past the edit time, just send the link to me and I will adjust your post as required by whatever their copyright is

thanks

http://industry.bnet.com/pharma/1000...mptoms-at-bay/

Title of article: Drug Shortage Has Parkinson's Patients in a Panic -- and No One Can Explain It

Bob, thanks for keeping this issue alive. On another discussion group, the parkinsn list, a member from France wrote that she hasn't been able to get Sinemet for a few months, but a generic form from Teva, has been available.

Switzerland has been buying from Sandoz, to replace Merck. I have been unable to get info from the other 135 countries where Merck sells pills. As my new friend in India says, it may not be a shortage of the drug; just a shortage of Merck labels. If so, the only result will be Merck's share price dropping as they concede one market after another to their competitors. Sinemet is listed by WHO as an essential drug that all nations must keep in supply, but they claim to have not heard about this situation. The Parkinson's advocacy newsletter in Switzerland is paid for by pharmaceutical companies; etc. But the mystery of Merck's behavior in this is bizarre. Jim Edwards at BNET called Merck's H.Q. and was told that the identity of the company that was supplying sinemet to Merck is "proprietary" information. The important information is kept secret from us.

In his Pharma Insight pages on BNET (CBS) Jim says:

"…Merck did not explain what the specific problem with the supply was. On Monday, Merck told BNET that the shortage “affects most markets,” but did not elaborate on why it is taking two years to change the supply source. A spokesperson said supply issues were proprietory and that the company expected regulatory approvals to be received by sometime in 2011..."

Bob,
When I looked at the Merck-Schering Plough website I was surprised to find sinemet not listed in their products. Well, it may be a co-incidence, but one the other hand maybe it is a product they want to lose, for some undefineable reason? On the other hand maybe the velvet bean crop in Tadjikistan or some other far flung place has succumbed to a pestilential beetle that has a taste for merck packaging, and they have had to move production to the southern hemisphere where the indigenous peoples use this usually very prolific plant to improve their soil.... all of which is at least as feasible as the story they have released................