Horrific Conditions Inside Drug FactoriesSeptember 2013
By William Faloon
I’ve never understood why people traffic heroin or cocaine when higher profit margins are available manufacturing prescription drugs.
In my early days I assumed that with their enormous price markups, at least minimum quality-control standards would exist at drug makers. How uninformed I was!
As history has taught us, pharmaceutical companies don’t care about their customer’s health. It’s not a part of their business model whether their drugs heal or harm. Their overriding concern is to make money.
Dietary supplement companies do not enjoy the gargantuan profit margins of regulated drug makers. Yet never have I seen such reckless disregard for consumer protection as has been exposed in the field of prescription drug manufacturing.
The FDA pretends to protect the public against contaminated drugs. The sordid facts reveal an agency incapable of acting in a rational manner, and when the FDA does something “after the fact,” they often create worse problems.
Such is the case of a company that made contaminated injectable drugs that sickened 745 Americans with 58 associated deaths at the time of this writing. 1
The FDA identified problems with this manufacturer as early as 2002, but dropped the ball into a state pharmacy board’s lap that failed to act. FDA again identified dangerous problems in 2006, but once more failed to take actions other than send a “warning letter.” The FDA now says it needs more power and money to do its job.
What the FDA does not want the public to know is that the reason this shady manufacturer was able to take over such a significant part of the market is that FDA actions caused other companies to stop making certain injectable drugs.
The media was initially confused by this tragedy and blamed it on lack of regulatory authority.
In this article, you’ll see past this charade as you’ll read how a drug factory pretended to be a compounding pharmacy. Particularly appalling is the FDA’s inability to recognize that making as many as 17,000 vials of a drug all at once under filthy conditions was a far cry from custom making one drug at a time per individual prescription in a sterile environment.
The contamination problem, however, is not isolated to one bad drug maker. It turns out that these kinds of safety violations were routine at drug factories that the FDA had certified as being safe.
US Drug Factories in ‘Terrible Shape’
Here’s how the New York Times described conditions inside FDA-registered drug factories:
“Weevils floating in vials of heparin. Morphine cartridges containing up to twice the labeled dose. Manufacturing plants with rusty tools, mold in production areas and—in one memorable case—a barrel of urine.” 2
The New York Times emphasized that these were not reports about the injectable drug maker that was linked to 745 cases of infection and 58 American deaths.1 These quality lapses were found at large drug companies whose names are familiar to many Americans.2
When these problems were discovered, the FDA sent out “warnings” to these companies. Instead of fixing the problems, many of these drug makers decided it was cheaper to simply discontinue making the drug(s). The result was severe shortages of the drugs cited by the FDA.2 This opened up the market for disreputable companies to make these same drugs, who did so under the same kind of abysmal conditions the FDA found at large drug factories.
The FDA would like to take credit for stopping these problems, but in certain cases, it was people working at the drug factories that came forward to complain about unsanitary manufacturing conditions, or people dying from contaminated drugs, that prompted FDA action.
The sad fact is that some drug companies are so greedy they will not stop their highly profitable assembly lines to perform even the most rudimentary sterilizing procedures.
Contaminated Injectable Drugs
Fungal meningitis causes inflammation of the lining of the brain and spinal cord that results in dreadful sickness and sometimes death.3
A drug factory made large quantities of a steroid (methylprednisone) that was injected into the joints and spines of aging humans in chronic pain. It provided temporary relief.
The problem was this drug was contaminated with a black fungus that infected those who were injected with it.4 Since injectable drugs bypass the natural barriers afforded by an intact digestive/immune system, they have to be manufactured and maintained in a sterile environment to avoid killing patients.
FDA inspections in 2002 and 2006 revealed injectable drugs being made under substandard (non-sterile) conditions at a drug factory. It was not until hundreds fell ill and scores died that the FDA took meaningful action.5,6
How the FDA Bungled the Investigation
The name of the company that made the fungus-laced injectable drug is New England Compounding Center (NECC).4,5 It pretended to be a compounding pharmacy, but instead functioned as a drug factory.
The FDA claims that it lacks adequate regulatory authority over compounding pharmacies, but FDA’s inspection of NECC in the year 2002 revealed problems with sterility and other issues.7 That same year, the FDA informed the Massachusetts State Board of Pharmacy of an adverse reaction to methylprednisone, which is the same drug that in 2012 caused the fungal-meningitis outbreak. 8
Had the FDA done their job back in 2002, they would have forced NECC to register as a drug manufacturer and subjected NECC to stricter regulatory oversight, although that may still not have prevented the problems since FDA-registered drug makers were later found to have similar unsanitary facilities.9
The FDA and Massachusetts state pharmacy board’s most blatant failure, however, was to uncover horrific conditions inside NECC and take no practical steps to enforce safety compliance or shut down NECC before tragedy struck.10
Good Manufacturing Practices Overlooked
According to Massachusetts state regulators, the NECC drug factory failed to sterilize injectable drugs, something that is mandatory for a substance that is going to be injected into the body.11
The regulators said that NECC didn’t keep manufacturing equipment clean, operated a leaky boiler near the “clean room” where injectable drugs were packaged, and shipped products before receiving test results showing the products were sterile, which violates good manufacturing guidelines. 12,13
In addition, NECC did not test the manufacturing equipment used to sterilize injectable drugs on a timely basis according to regulators.13
The result of these multitudes of quality lapses were injectable vials that contained black matter inside, which turned out to be the fungus that has been linked to 58 deaths so far.1,10
FDA Inspects After Catastrophe
After hundreds had fallen ill from fungal meningitis, the FDA conducted a thorough inspection of NECC’s drug factory.14
The FDA’s report cited greenish-yellowish discoloration on sterilization equipment and non-sterile raw ingredients. The FDA found that 25% of supposedly sterile vials were contaminated with greenish-black foreign matter and that 100% of these vials sent for analysis contained fungus.14
The FDA noted that NECC was unable to provide documentation that its steam autoclave devices were capable of achieving product sterility, a critical factor when making injectable drugs.10,13 In fact, FDA inspectors found greenish-yellow discoloration inside the one cleaning autoclave and a tarnished discoloration inside another.13,15
NECC turned off its air conditioning in “clean rooms” from 8:00 pm to 5:30 am, which is improper because failing to keep clean rooms at low temperature and low humidity provides a fertile environment for fungal growth.14,15
Particularly troubling in the FDA report was documentation that NECC had found microbial contamination, but did not enact cleanliness procedures to neutralize this lethal threat.14
Furthermore, “clean rooms” used to make injectable drugs had been identified by NECC’s own staff as detecting bacteria and molds, but the FDA could find no evidence that the company acted to fix these lethal problems.14
The FDA’s belated inspection of NECC did nothing to prevent the suffering and death of hundreds of victims who contracted fungal infections from contaminated vials of methylprednisone injected into their spines and joints.10
Congress Cites FDA Failure
The House and Senate held several hearings in November 2012 on the NECC tragedy.
Congress wanted to know why the FDA didn’t do more to prevent the production and sale of these tainted steroids.
As anticipated, the FDA claimed that it didn’t have enough authority to regulate pharmacies that compound drugs. FDA Commissioner (Margaret Hamburg, MD) warned that if Congress didn’t strengthen legislation, another similar tragedy is inevitable. Dr. Hamburg stated before the House committee:16-18
“ If we fail to act, this type of incident will happen again. It is a matter of when, not if .”
What Dr. Hamburg may not have expected was documentation that the FDA and the Massachusetts pharmacy board both repeatedly visited NECC and found problems, but the strongest action the FDA took was the issuance of a warning letter in 2006.
In response to Dr. Hamburg claiming the FDA needed more “authority,” one Representative responded:
“We’re just not buying it, doctor … You lack the authority to do anything, yet you send a letter like this?”
(In reference to FDA 2006 Warning Letter).
This warning letter documented numerous violations of existing rules the FDA found in 2006, yet the FDA failed to take action until citizens started dying.
House members repeatedly berated regulators who failed to prevent the fungal meningitis outbreak, stating the FDA and Massachusetts state regulators both knew as far back as 2002 that there were problems at the pharmacy, which distributed more than 17,000 doses from contaminated lots of steroids.
Dr. Hamburg was lambasted by House Committee members who stated:18
“This is a complete and utter failure on the part of your agency.”
“This is one of the worst public health disasters ever caused by a contaminated drug in this country.”
“After a tragedy like this the first question we all ask is ‘Could this have been prevented?’ After an examination of documents produced by the Massachusetts Board of Pharmacy and the US Food and Drug Administration, the answer here appears to be, ‘Yes .’”
Other House members came to Dr. Hamburg’s defense, arguing that a solution needed to be found instead of seeking to “prosecute the Food and Drug Administration.”