Friday, January 17, 2014



The chemical "sea of pills".

Special thanks to "Google Images", "CBS News - 60 Minutes",
"The Association of Trial Layers of America",
"The New York Daily News", "The Guardian - UK" and the "New York Times"

by Felicity Blaze Noodleman
Los Angeles, CA

Now that mandatory health insurance for all US Americans is the new Federal law the health care industry is sure to see their business spike upwards on all fronts.  More, more and more of everything.  Is this a good thing? The flood gates are about to open on us all and we all could drown from the consequences!  We could see shortages for many medications and possibly lower quality pharmaceuticals as manufacturing facility's are forced into higher production.  As the old expression states, "be careful of what you wish for"!  The following 2010 article from the "CBS news program 60 Minutes" explains how this is already happening.

"CBS News - 60 Minutes"

Scott Pelley Reports Interviews
Whistle-Blower Cheryl Eckard

       Dec 29  CBSNews

Cheryl Eckard
Of all the things that you trust every day, you want to believe your prescription medicine is safe and effective. The pharmaceutical industry says that it follows the highest standards for quality. But in November, we found out just how much could go wrong at one of the world's largest drug makers. A subsidiary of GlaxoSmithKline pleaded guilty to distributing adulterated drugs.

There was reason to believe that some of the medications were contaminated with bacteria, others were mislabeled, and some were too strong or not strong enough. It's likely Glaxo would have gotten away with it had it not been for a company insider: a tip from Cheryl Eckard set off a major federal investigation.

She's never told the public what she saw inside Glaxo, but now she has. Her story opens a rare window on how one company traded its good name for bad medicine.

Glaxo Response to "60 Minutes" Report:
GlaxoSmithKline [GSK] issued the following response regarding a 60 Minutes program on January 2 that focused on a manufacturing facility in Puerto Rico which was formerly owned by the company.

GSK regrets the manufacturing issues at the Cidra facility, which were inconsistent with GSK's commitment to manufacturing quality. It is important to note, however, that the issues outlined in the 60 Minutes story occurred in the past -- between 2001 and early 2005 -- and related to one manufacturing facility. GSK had been working with the U.S. Food and Drug Administration to improve the plant's performance as early as 2001, before Cheryl Eckard was sent in 2002 as part of the team to address the issues cited by the FDA.

GSK strongly disagrees with 60 Minutes' implication that patients suffered harm as a result of the Cidra issues. The FDA; the US Department of Justice; and Neil Getnick, Cheryl Eckard's attorney, all stated there was no indication that patients were harmed as a result of the production issues at Cidra. Massachusetts U.S. Attorney Carmen Ortiz herself stated: "We did not uncover any evidence that patients were harmed from these adulterated batches."

GSK's manufacturing division has a strong track record of quality and compliance with current Good Manufacturing Practice (cGMP) requirements. Various regulatory agencies - including the FDA - conduct an average of more than 100 inspections each year at over 80 GSK manufacturing sites located in over 30 countries. The FDA has raised no material issues as a result of its very thorough inspections. GSK is committed to continuous improvement in our manufacturing processes. Patients should have a high level of confidence about GSK's manufacturing and the quality of our medicines.

GSK worked to bring the Cidra facility to a high level of operating performance that satisfied both GSK and the FDA. The plant was closed in 2009 due to a declining demand for the medicines made there. The company strongly rejects any claim of retaliation for whistle-blowing. In fact, employees are encouraged to report any concerns they might have to management or through a confidential compliance hotline. Issues raised are investigated, and company policy prohibits any retaliation against employees.

Eckard worked in Glaxo quality control and over ten years she had risen to become a manager of global quality assurance. Her job was to inspect plants to make sure that the drugs had the right ingredients, the right potency and met government standards for purity.

In 2002, Eckard was assigned to help lead a quality assurance team to evaluate one of Glaxo's most important plants, in Cidra, Puerto Rico. Nine hundred people worked there, making 20 drugs for patients in the U.S. But Eckard says that when she saw what was happening to some of the company's most popular drugs, she couldn't believe it.

"All the systems were broken, the facility was broken, the equipment was broken, the processes were broken. It was the worst thing I had run across in my career," she told "60 Minutes" correspondent Scott Pelley.

The worst, because so many things behind the walls of the plant were going wrong at once: Eckard says water used to make tablets was tainted with bacteria; failures on production lines made some drugs too strong, some not strong enough; and the employees were contaminating products, including the anti-bacterial ointment Bactroban, which was made in a sealed tank to prevent contamination.

"They were opening up the lid and then they were sticking their body into the tank and scraping it with like a paddle," Eckard said.

"But this product is supposed to be free of bacteria. Why would they do that?" Pelley asked.

"It saved money," Eckard replied.

As her team continued its evaluation of the plant, Eckard says she discovered something much worse than contamination: because of failures on various production lines, she says that powerful medications were getting mixed up.

"Are you saying that different kinds of drugs were packed into the same bottle?" Pelley asked.

"Yes. And that's shocking," she replied.

Eckard says a chart that she produced for company executives shows the kinds of mix-ups that were happening at Cidra. She identified nine, including Avandia diabetes pills mixed in packages with over-the-counter Tagamet antacids and Paxil antidepressants, mixed with the Avandia diabetes drug.

"When you saw these mix-ups happening, what did you do?" Pelley asked.

"I contacted the vice president of quality for North America and I told him that he needed to shut down the factory and call the FDA," Eckard said. "I urged him to stop the trucks that were leaving the dock that day."

Asked what happened then, she told Pelley, "I went back to work and waited for the news that they had called the FDA or that they had stopped shipments, and it didn't happen."
This article continues at
"CBS News - 60 Minutes"

We are re posting this article from 2012 with some new information from the Supreme Court regulating lawsuits targeting the Pharmaceutical Industry as we all begin to venture down the "Obama Care" road.  It is not the "prim rose path" many will be expecting.  Beware and beware!

"American Association for Justice"
Formerly "The Association of Trial Layers of America"


For Immediate Release: June 24, 2013

Contact: Jennifer Fuson
Cell: 202-944-2896

Generic Drug Manufacturer Escapes Liability for Safety of its Drug  
 Washington, DC—The U.S. Supreme Court gave pharmaceutical companies another gift today, largely shielding the generic industry from lawsuits for the design of their drugs.  This is the second Supreme Court decision giving the generic drug industry immunity. In 2011, the Court decided generic makers cannot be held responsible for failing to warn about a drug’s side-effects, saying the generic maker is only making a “copy” of the brand drug and must follow the brand drug’s label.
“I know of no other industry where the maker of a product has such limited responsibility for the safety of the product they make,” said American Association for Justice President Mary Alice McLarty. “Over eighty percent of drugs dispensed are generic; the manufacturers must be held responsible for their drugs’ harmful effects.”
The case Mutual Pharmaceutical v. Bartlett is about Karen Bartlett, a woman who permanently suffers from Stevens-Johnson syndrome after taking the generic drug sulindac for shoulder pain.  The disease left Karen nearly blind and caused over 60% of her skin to burn off.  She spent months in a coma and a year being tube fed. She is permanently disfigured and will need care for the rest of her life.
Two lower courts in New Hampshire ruled sulindac is unreasonably dangerous and awarded Karen $21 million.  The Supreme Court’s decision nullifies those rulings.
“It has been two years since the Supreme Court granted generic drug companies immunity for their drugs’ warning labels in Pliva v. Mensing.  Today the Supreme Court expanded that immunity. It is time for the FDA to address the huge disparity between generic and brand drug makers’ responsibility,” added McLarty.
Members of Congress (Senator Leahy and Senator Landrieu) have sent letters to the Food and Drug Administration, calling on the agency to address generic drug accountability.  Public Citizen also filed a citizen petition asking the FDA to address the Mensing decision.  AAJ filed comments in support of the petition.
Hundreds of cases have been dismissed because of the Supreme Court’s Pliva v. Mensing decision.  Public Citizen issueda new report today highlighting how many potential hazards are not discovered until years after drugs have been on the market and the risk this poses to patients.  Here you can see examples of real people that have been denied access to justice just because they took a generic drug.

"American Association for Justice"
Formerly "The Association of Trial Layers of America"

As we venture into the "Obama Care" era it would seem that the rules of law have changed and the health care industry will have less regulation; the checks and balances to insure patent safety will have a legal recourse in the event we are injured by medicine.

In 2012 it was reported that the British pharmaceutical company "GlaxoSmith Kline was fined $3 billion for promoting antidepressants for unapproved uses and for failing to report safety data about a top selling diabetes drug.  There were also civil penalties for the improper marketing of half a dozen other drugs according to Federal prosecutors.

There were so many dynamics to this case that I can’t believe it.   Here are some excerpts from the press of the day.  If this were to happen in the future; what then?

·       Prosecutors said Glaxo illegally promoted Paxil for treating depression in children from 1998 to 2003, even though it wasn't approved for anyone under age 18. The company also promoted Wellbutrin from 1999 through 2003 for weight loss, sexual dysfunction, substance addictions and attention deficit hyperactivity disorder, although it was only approved for treatment of major depression.   
      "The New York Daily News"

·       The pharmaceutical group GlaxoSmithKline has been fined $3bn (£1.9bn) after admitting bribing doctors and encouraging the prescription of unsuitable antidepressants to children. Glaxo is also expected to admit failing to report safety problems with the diabetes drug Avandia in a district court in Boston on Thursday.  The company encouraged sales reps in the US to mis-sell three drugs to doctors and lavished hospitality and kickbacks on those who agreed to write extra prescriptions, including trips to resorts in Bermuda, Jamaica and California.
      "The Guardian - UK"

·       Part of the civil settlement also includes claims that the company overcharged the government for drugs. Glaxo did not admit any wrongdoing in the civil settlement. Despite the large amount, $3 billion represents only a portion of what Glaxo made on the drugs. Avandia, for example, racked up $10.4 billion in sales, Paxil brought in $11.6 billion, and Wellbutrin sales were $5.9 billion during the years covered by the settlement, according to IMS Health, a data group that consults for drugmakers. “So a $3 billion settlement for half a dozen drugs over 10 years can be rationalized as the cost of doing business,” Mr. Burns said. Mr. Burns and others have said that to institute real change, executives must be prosecuted criminally or barred from participating in the Medicare andMedicaid programs, an action known as “exclusion.”     
     "The New York Times"
It should be noted that 2012 is became a record year for fines set by the Fed. In these kinds of judgments!  What is also really distasteful is a video made at a GlaxoSmith Kline sales convention which shows company representatives offering huge cash incentives and other perks for the promotions of their drugs and other supplies.  Other big pharmaceutical companies which have been prosecuted and fines in the recent past include Pfizer Inc. settling for 2.3 Billion; Eli Lilly & Co fined nearly 1.5 Billion. and Abbot Laboratories settled for 1.6 Billion.  Johnson & Johnson has had two serious recalls of their “Tylenol” products and their problems just don’t seem to end with a fine which could result in 2 Billion settling for its “Risperdal” drug.

Our article from 2012 continued: The fact which really blisters me about this case is the exploitation of children with powerful psyche. Meds. in this case.  Drugs for adults and not approved by the FDA for children were being promoted to Doctors by GSK.  Drugs which are known to cause suicidal behavior in teens.  When I first heard of this case it raised my interest in writing this article, but as I study it more closely I am beginning to see the really criminal direction this industry has been moving in for some years now! 

I can also say that it seems to me that our youths have become more dependent than ever on so many drugs.  I have to ask what is going on?  This was not the case when I was growing up.  Is it a result of what I call “The Frosted Flake Syndrome”?  Too much sugar in children’s diet and adults who can’t cope with it all?  Children who have become diabetic and are on a regiment of “Ritalin”.  I wonder.

This is becoming a sad commentary on childhood these days.

I suppose we should be glad to see a system in place which oversees and deals with problems of this nature but it’s alarming to see so much happening all at once.  It seems to me that the drug companies have become extremely profit motivated and have thrown caution to the wind as they market their products like never before.   It all reminds me of the drug “Thalidomide” which was marketed in the late 1950’s.  Thalidomide was found to cause birth defects when taken by pregnant woman and had to be pulled.  What a nightmare!

What governs today's health care system?

Pharmaceutical companies view fines in cases like this as “the cost of doing business” and know that the judgments legally point out the way in which they may proceed in the future.  Eliot Spitzer, New York Attorney General, has remarked regarding a 2004 judgement against GSK "this kind of corporate arrogance will continue unless company officials are held accountable for the criminal behavior of their companies".  What is really startling is when it comes to writing legislation in congress for these companies the authors are industry insiders.  After all, they are the experts and congress has very little to do with the process and oversight only arises as a result of a specific problem which has occurred in a mass incident.  It should be noted that the FDA is also made up of these insiders as well.

There have been other cases in the past related to a number of problems in the pharmaceutical Industry.  At one time or another all the companies have been sued in court or have had recalls over a number of various products.  Law firms quite often are looking individuals who have taken a drug as they are preparing for a class action law suit or law firms which are dispensing payouts for a legal settlement by drug companies.

All too many evenings I have watched a parade of TV ads. For new drugs and have been horrified as the side effects have been listed.  Advertising directly to the public is something relatively new for the drug companies.  In the past new pills and treatments have come to us through our doctors.  As I watch these television commercials I have to ask myself am I a doctor?  How do I know if I might need this new miracle cure?  They advise “ask your doctor” or “You could benefit when added to something you are already taking”.  What is becoming all too clear though is how far pharmacological companies will go for profits in marketing their drugs.

The costs of doing business with these companies.

If we view things on a really personal level than it becomes largely apparent that pharmaceutical companies are the real drug pushers in our society and they are bullies who have an arsenal of inducements at their command to convince the public to buy their “stuff”.  From the Federal governments Medicare programs down through the state level, such as here in California with Medical, government is the biggest customer in dispensing the pharmaceuticals to the public at large.  Insurance companies also have become a target for drug companies to “unload” their merchandise.

Too often in the news we hear of the tragic deaths which have occurred from the extreme miss use of pharmaceuticals.  Some under physician’s oversight and also by over dosages and abuse by individuals.  An area of great concern is physical conditioning in the sports world and individuals seeking to achieve a muscular physique through the use of a multitude of different pills and injections. Is this what they mean when they say “better living through chemistry”?

Now let me ask a question.  Would you take a drug or pill if you knew that in the future you would develop severe complications?  Many people begin a regiment of pills at a young age during a time in their lives when they are relatively healthy.  Added to this regiment are vitamins, health supplements and so forth.  What is going to happen in the future when new illnesses develop as a result of aging? Isn’t it wise to be prudent?

Let me tell you a story.  A friend of mine has been on chemotherapy for a number of years.  He became ill with a cold and took an over the counter remedy.   He became very ill with and interaction which easily could have resulted in death.  The moral of this is obviously to check with your Doctor about everything you take.  Isn’t that a good rule in general for all substances we’re taking?

Obviously pharmaceutical serve a valid purpose and fill a legitimate need in society.  I’ve seen firsthand for myself radical transformations for the better with patients who suffer with a variety of illnesses and have to be grateful for the availability of such “wonder drugs”.  Let’s all hope that prudent progress will guide the way for us all!  

Next week we will be looking at our US winter Olympic teams who will be competing is Sochi, Russia for the gold.  I'm Felicity with the "Noodleman Group"!

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