Are Prescription Drugs Pure?
I thought that I would mention the following as a counter to inferences by some in the medical fraternity who claim that supplements are not pure. Of course there is no argument that some are not as indicated by an earlier posting that I did 'Genuine mistake or Dishonesty'.
Let me give you a couple of examples about 'lack of purity' in the drug industry.
In May 2009 Johnson & Johnson had bacteria contamination and other problems in 40 varieties of children's cold medicines. They had to close the plant that manufactured the drugs.
Earlier this year GlaxoSmithKline (GSK) settled a criminal and civil complaint at a cost of $750 million. This was from a plant in Puerto Rico that at one time produced around $5.5 billion worth of GSK product each year, such as Paxil, Avandia and other good sellers. Some drugs even had the active ingredient missing.
Interestingly when the sent their QA manager there to investigate some years ago and she filed a negative report she was fired. She has since successfully sued the company.
These are only a couple of examples.
Why do I mention all this? Simply to help balance the 'playing field' as the media seldom report problems like this, but they jump on supplement companies... which they should... but, ALL cases should be reported including sloppy manufacturing by Pharmaceutical Companies.
Late last month, GlaxoSmithKline paid out $750 million to settle a criminal and civil complaint stemming from problems at a large manufacturing plant in Puerto Rico that produced many GSK products. The New York Times reports that the plant was "rife with contamination" for years.
At one time, about $5.5 billion worth of GSK products were manufactured there yearly, including Paxil, Avandia, Tagamet, and other best selling drugs. In addition to contamination, some lots of Paxil were actually missing the active ingredient. In other words, they were inadvertently making and selling placebo pills (at full price, of course!).
The lawsuit also reveals that an FDA inspection missed most of the problems at the plant. GSK promised to fix the problems that were caught, but then didn't follow through.
There's your good, solid FDA regulation and dependable drug purity–out the window!
In a statement from GSK, executives expressed regrets about violating good manufacturing practices.
I'll bet that's the least of their regrets.
Eight years ago they sent their quality manager, Cheryl D. Eckard, to Puerto Rico. After examining the plant with a team of quality control experts, Eckard reported multiple violations, including contamination in the water and air systems, and a lack of sterility of some intravenous drugs.
When Eckard pressed senior managers to recall certain lots of drugs, they not only ignored her, they fired her.
That turned out to be a $750 million blunder.
Eckard filed a whistleblower lawsuit against the company. All the beans were spilled. The plant was closed in 2009. Eckard won her suit last month and will collect a $96 million award.
You know as well as I do that it likely doesn't stop at GSK and Johnson & Johnson. The industry that we always knew was dirty in its marketing, research and business practices adds manufacturing to the list.
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