Paula,
That is not off-topic. That is the topic.
We are dying.
So we get to say.
We get to choose.

We have the right to know what the secret cabals are cooking up for us in our absence. When Merck decided to halt production of an addictive drug we need to function, our needs, the customer's needs, are not represented and not present.
We do not have to whisper and beg.
Pharma took a wrong turn some time ago.
Pharma flunked the litmus test.

We would like to think that the medical industry would learn something from the Amgen GDNF fiasco.
But apparently not.
Strategic error, ongoing, committed by Pharma and abetted by most of the industry.
Pharma shot itself in the foot and keeps sending us the bill for their new shoes.
The monthly scandals in Pharma - the illegal acts, bribing doctors, deliberately falsifying medical research, slipshod clinical trials resulting in unnecessary deaths, advertising that they know is false; pushing drugs into categories of treatment that the drug was never tested for; conducting clinical trials in Third World countries where life is cheap; experiments so down and dirty that they would never be permitted in our countries - but the trials are being done in our name for our benefit. An old worn out example that never got resolved, and that contains all of the horrors of a psychopathic nightmare: the drug that was banned in North America, Europe and Japan as being too dangerous. How did we know it was too dangerous? Well, the clinical trial in Nigeria, to test the drug.... trials for which Pfizer did not get permission... proved that the drug was no good. Because 11 of the NIgerian children died, 200 were injured.
But they had signed waivers. The Nigerian children had signed waivers.
None of this is off-topic.
Pharma, the entire industry, is going to fall off a cliff. It has become a rogue industry, a den of deceivers; anti-health, anti-human, sick-making, nausea inducing, dishonest, corrupt, and yet fossilized at the same time.
I don't really care much anymore as long as they stay out of my life. They cannot be defeated, they will collapse from inside eventually; nothing that works like that can succeed.
Pharma will have to shape up or ship out; and they have no inkling of that at all; they do not see that they missed the turning point and they are speeding madly into oblivion. In their present form. They are old-time pirates, but the day of pirates is over.
Now let's see, what's the Pharma scandal of the month? Good God, there are so many, it's a lot more than one a month. Oh here's a good one.... criminal actions by Pharmacia expected to result in fine of $21 billion...
It's a rogue industry. It will go down. Things that function this way do not survive.

Now let's see, what's the Pharma scandal of the month?

In what country should I begin?

thanks for the validation of the reasons for my frustration.

I said a scandal a month. More like one a week, or, below, one a day for a week for just one company. Rogue industry.

AlterNet - article by Martha Rosenberg
Durng one week in June, 2010, Pfizer 1) agreed to pull its 10-year-old leukemia drug Mylotarg from the market because it caused more, not less patient deaths 2) Suspended pediatric trials of Geodon two months after the FDA said children were being overdosed 3) Suspended trials of tanezumab, an osteoarthritis pain drug, because patients got worse not better, some needing joint replacements (pattern, anyone?) 4) Was investigated by the House for off-label marketing of kidney transplant drug Rapamune and targeting African-Americans 5) Saw a researcher who helped established its Bextra, Celebrex and Lyrica as effective pain meds, Scott S Reuben, MD, trotted off to prison for research fraud 6) was sued by Blue Cross Blue Shield to recoup money it overpaid for Bextra and other drugs 7) received a letter from Sen. Charles Grassley (R-Iowa) requesting its whistleblower policy and 8) had its appeal to end lawsuits by Nigerian families who accuse it of illegal trials of the antibiotic Trovan in which 11 children died, rejected by the Supreme Court. And how was your week?

http://www.alternet.org/story/147467/?page=entire

Parkinson's volunteers for Amgen GDNF.
Merck's bizarre refusal of their most fundamental human responsibility
And then we start to look around at Pharma. New scandals daily.
From the Washington Post:
...."Pfizer violated international law by testing the drug, known as Trovan, on perilously ill children without their knowledge. Eleven children died during the 1996 clinical trial… other children developed brain damage and crippling arthritis…
Pfizer carried out the experiment on 200 children at a makeshift epidemic camp in the Nigerian town of Kano. The articles reported that Pfizer had no signed consent forms for the children and relied on a falsified ethics approval letter…

http://www.washingtonpost.com/wp-dyn...013003432.html

AMgen.
Sinemet shortage.
Testing our drugs on hundreds of Nigerian school children and then forging documents to cover up....

You see, Pharma, the problem is:

WE ARE NOT THAT KIND OF PEOPLE.
WE NEVER WANT TO BE THAT KIND OF PEOPLE.
We do not tolerate that kind of thing.
We know right and we know wrong.
Stop all research, rather than murder African children.
We are not that kind of people.
We do not accept that such things are done.
And the fact that Pharma cannot even grasp the concept is an indication of how close they are to hell itself, but instead of waiting decently to die before going to hell, they created hell here on earth.
Pharma's behaviour is way, way, way beyond what anybody can get away with. They are finished. Oh, they will lurch around for some years, but they are finished. Their credibility is gone, their research is deliberately falsified, but most of all, they cannot be trusted, and in health care, that's not what works.
We don't go to Third World countries and inject an unproven drug into 200 school children without the knowledge of their parents, and without approval from the health authorities. Eleven died, many of the remaining 200 suffered life-time physical and mental handicaps.
And the same company, Pfizer, was fined $2.3 billion for criminal activities in the U.S.A.
Now, if you were President of that company, or a shareholder, or in management, and there's the $2.3 billion fine, the largest in American history, and these dead African kids, and your products being forbidden because they increase the death rate... would you not feel bad, maybe apologize to the people whose lives you ruined, maybe fire a vice-president or two, maybe resign yourself...
if that was your company, would you not feel embarrassed? Pharma does not embarrass. They know the difference between right and wrong; they find that wrong is more profitable.
But we don't allow that. Pharma's behaviour is not acceptable, not legal; it is a stain on the history of our generation here on earth.
You don't treat people like that.
And so Pharma is finished. Elephants have a long memory.
And, in life, you get away with nothing. And we are not the kind of people who test our drugs on children without the parents knowing... these children came mostly from the same neighborhood in Kano, Nigeria. In some blocks of the city, almost all of the children were gone. 11 dead, officially (some parents in Kano say it was 50 dead) and 200 permanently damaged, mentally and physically, mostly all from the same apartment blocks. The play-ground was suddenly empty.
We are not that kind of people. We do not accept or tolerate these criminal acts. We protect children. We would rather die in dignity than have a cure that requires going into Africa and murdering school children.
We don't want to be that kind of people. That is not who we are, not at all.
Our elected officials are not so sure.

Ah, with Merck, the “manufacturing issues” turn out to be the norm. So the shortages of Merck drugs appear to be sheer incompetence. They may also be breaking the law in various ways, but based on what little evidence is available from the cloistered, closeted and secretive company, they are very good at selling products but have no idea how to make the products.

Random news clips about Merck:

….Merck (MRK) used a deft bit of spin to disclose in a quarterly 10-Q filing that it is being investigated by the Department of Justice and the SEC for possible violations of the Foreign Corrupt Practices Act, which prohibits paying bribes to do business in foreign countries. Merck said it believed the inquiries were a “review” that was part of a “broader” inquiry into pharmaceutical companies generally.
http://www.overoll.com/image/787702

…The international pharmaceutical giant Merck Sharp & Dohme Co. has reacquired the Cherokee Pharmaceutical plant it sold to PRWT Services Inc. 2 1/2 years ago.
…In an unrelated development, Merck disclosed Monday that it is being probed by two federal agencies for possibly violating laws in multiple foreign countries, according to an Associated Press report….
http://dailyitem.com/0100_news/x1189...rside-facility
.. Merck continues to have difficulties with some of its adult vaccines. As previously noted, the adult version of Recombivax will not be available at all this year, after the drugmaker had hope to restore supplies by mid-2010. And orders placed for the Zostavax shingles vaccine after mid-May won’t be filled until November or December.
Merck has struggled with vaccine production issues for more than two years. The FDA issued a warning letter in April 2008 after an inspection found a ” number of significant objectionable conditions relating to your firm’s compliance” with good manufacturing practices.
http://www.pharmalot.com/2010/08/mer...28Pharmalot%29

…No end in sight for adult hepatitis B vaccine shortage
Merck & Co., Inc. does not anticipate that the adult formulation of its hepatitis B vaccine will be available for the rest of 2010.

The lengthy and ongoing shortage of adult hepatitis B vaccine has baffled some public health doctors.

“Why is there a shortage for a stable vaccine that has been around for years?” asks Dr. Vinita Dubey, associate medical officer of health for Toronto Public Health’s division of communicable diseases. “This is a real public health concern.” …..According to the Public Health Agency of Canada (PHAC), other provinces and territories have also been forced to amend immunization programs.

“There are logistical challenges of trying to catch people up on immunizations that may have been delayed due to the shortage,”

The shortage began in January 2009, when Merck & Co., Inc. announced that equipment upgrades at its vaccine plant in West Point, Pennsylvania, would disrupt production of the adult version of its hepatitis B vaccine (Recombivax HB®). The vaccine will likely remain unavailable for the near future.

….Jennifer Allen Woodruff, a spokeswoman for Merck, writes in an email. “Over the last couple of years, supply disruptions have occurred due to unexpected manufacturing issues that prompted modification to some of our processes and equipment. …
http://www.cmaj.ca/earlyreleases/27j...e-shortage.dtl

The Parkinson's Disease Foundation posted the following clarificatioin about another possible sinemet shortage yesterday. Thank you PDF and PAN for getting this information out.


The Availability of Sinemet for People Living with Parkinson’s
- Aug 20 2010

In recent months, the Parkinson’s Disease Foundation (PDF) has received questions from people living with Parkinson’s disease (PD) about a potential shortage of levodopa/carbidopa, or Sinemet®, the gold-standard medication for Parkinson’s.

On Friday, August 19, a representative from, Merck and Co., Inc., the supplier of the medication, sent a letter about the matter to the Parkinson’s Action Network (PAN), the Washington, DC based voice of the Parkinson’s community.

The letter states that for people living in the US, there currently is neither a shortage of Sinemet nor Sinemet CR ®.

Please read the full letter below and/or download the letter to see details about availability by country

see http://www.pdf.org/en/science_news/r.../pr_1282318230

-------------------------------------------------------------------------------------------------------
People like Lyndy and Bob would know better, but it seems to me that the new merck letter contains the same type of vague statements that they have been givven in the past. Does anyone see any new info here?

Thanks for posting this, Linda. I have pretty much given up following this story because Merck will never speak unless forced to by police investigation, which is not going to happen. So thank you for keeping watch in case new information comes out.

The only new item is a list of countries and a vague reference to when they might be permitted back into Parkinson's treatment, at the whim and mercy of Merck. There is, of course, no mention of what percentage of their needs each group of hostages (patients) will be granted by Merck, the owners of the disease. There is no mention about why some countries get all they need and some do not. Hilarious, of course, that Spain gets full supply - the only country where People With Parkinson's have a Parkinson's organisation that demanded that their government press criminal charges against Merck; production of sinemet in Spain started up again within three days and the temporary shortage in Spain was resolved overnight by diverting supplies from other countries.

Merck sells drugs in 81 countries. Most are not on the list. A man in Kenya told me there was no more supply at all. Merck's list covers Europe, Canada and the USA. Countries with a darker complexion failed to get their names on the list, of this world-wide shortage, which is "being managed" by Merck according to their own "allocation system", a system only they know about.

And, as usual, they want millions of Parkies around the world to go see their neuro. Just line up at the door. And then the arrogant claim that having your drug supply cut off and replaced with something more profitable is "common clinical practice", which of course it is, especially among doctors who regularly receive bribes from Pharma or who know very little about PD anyway.

The business model does not work because the customers are not part of the picture, so the suppliers can get away with anything.

My car got recalled - President of the Japanese car company had to fly to Washington and got grilled on live TV by a Congressional committee; and had to explain what had gone wrong and how it was going to be fixed.
But drugs vital for your survival disappear from the pharmacies and show up on the black market (Google this: buy sinemet) and the people whose health is put in danger are greeted with scorn and derision and no information.

The free market business model does not work if the customers are not part of the picture.

We are still where we were a year ago. Did their factory burn down? We would understand that. But they shut down production at one place without arranging an alternative. Wild, unthinkable incompetence, if we assume that is was not criminal negligence. If Parkies had any say in the multi-billion dollar industry that has grown around us to profit from our illness, then it would be very simple: for whatever far-fetched reason, Merck failed in their primary duty as a provider, a supplier of drugs to people with an incurable disease. In any business working without hostage customers, Merck would simply be fired, their contract torn up, their licence revoked. They failed miserably, and they insult us with their condescending lies and cover-up.

Merck is proving to the drug industry that they need not fret; they can get away with anything, and for them, it is free of consequences. A remarkable demonstration of power.
For shame.
But Pharma in general has miscalculated again and again. Like the Amgen mistreatment of the PWP volunteers, this will be remembered; and Pharma is making grave strategic errors. Some day it will all come back to haunt them; people are not as stupid or as morally dead as they think.

Mysteriously there appears to be little shortage now in the UK. People have been shifted from one drug to another, not always successfully, and there are indications that supplies of some of those drugs are also now affected.......

However the list that Linda has brought to our attention that was published in the US reads differently from the list that appears on the EPDA website, at least it is expressed differently. As far as I can see subject to regulatory approval means a shortage, because those approvals have not yet come through. The EPDA list indicates continuing shortages in a number of countries, some through the latter half of this year, and some through 2011.

The second round of questions (additional) in the UK was not answered adequately, and was brusque and overbearing, with the odd statement here and there that they have the patients welfare to the fore........ Nothing they have done suggests this, and it is only as a result of patient pressure that they have done anything to inform patients. The last round of questions did however try and shunt the cause of the shortage onto the supplier of raw material - in the previous round of questions it was deemed to be the regulatory process itself that was at fault. MSD itself is squeaky clean and has done nothing whatsoever that it will admit to - though it's answers are so rigidly controlled that it is clear it has taken legal advice........ if so why?

So this is a company that has no control over it's supply chain, and cannot forward plan effectively enough to meet the approvals it needs to produce and distribute it's product........ yet it has been in the business of this for years..................

What looking at this situation has uncovered is a variety of sharp practice, and overwhelming disregard for other aspects of drug regulation, such as maintaining supplies, not just with MSD but also with many other companies that amounts to those companies seeing themselves way above the law, and also willing to exploit the differences between law in different parts of the world in order to maximise profit, with a flagrant disregard of the needs of patients. Nothing new, but the last year has seen this just rise and rise.......
and a kind of corporate daredevilry in the way it is done, just as the banks have ridden roughshod over law, so are these companies........

This is happening globally, and should be regarded as something that citizens of the world should tackle before it is so entrenched that there is no turning back. As individuals we mean little, as patients we are simply a means to a profitable end, but collectively people can change things, nationally and globally. If there are initiatives to curb these abuses in your neck of the woods you should where possible support them, and support the people who support them too.

I don't know where it starts, but something needs to turn this tide...... if I am idealistic about this it is because I know the things that we are able to find out are just the tip of the iceberg........

Lindy

And thanks and gratitude to the PDF - Parkinson's Disease Foundation - for writing to Merck even though they did not dare allow a shortage in the USA.
PDF is one of the rare groups to let merck know they are being watched.

Oh it was PAN - Parkinson's Action Network - that sent the letter to Merck - PDF put it on their site.
I wish I had a list of PD groups with a frank statement of the stance, the approach, the philosophy of each.