CBS News enables FDA to
by William Faloon
If you watched CBS News 60 Minutes last night, you witnessed the kind of misleading reporting that enables federal agencies to gain unbridled power.
60 Minutes accurately told the story of an unscrupulous manufacturer of contaminated drugs that caused 48 deaths and over 700 serious illnesses.
60 Minutes omitted the fact that the FDA knew about this disaster-waiting-to-happen as far back as 2002, but failed to stop it until Americans started dying in 2012.
FDA officials were given free rein on national TV to blame this tragedy on a lack of regulatory authority. As you'll read here, the fault instead lies with bureaucratic incompetence at the hands of the FDA and the state pharmacy board that permitted these lethal deviations in good manufacturing practices to occur.
Particularly appalling is the FDA's inability to recognize that manufacturing as many as 17,000 vials of a drug all at once under filthy conditions was a far cry from compounding one drug at a time in a sterile environment.
The contamination problem, however, is not isolated to one bad drugmaker. It turns out that these kinds of safety violations were routine at drug factories that the FDA had certified as being safe.
Instead of blaming the FDA for ignoring this lethal problem, CBS News let FDA officials blame Congress for not giving the FDA more regulatory power over pharmacies.
The FDA pretends to protect the public against contaminated drugs. The sordid facts reveal an agency incapable of acting in a logical manner, and when the FDA does something "after the fact," they often create worse problems.
Such is the case of a pharmaceutical manufacturer that made contaminated injectable drugs that have killed 48 and sickened over 700 Americans. 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. The FDA again identified dangerous problems in 2006, but once more failed to take actions other than send a "warning letter." The FDA now claims it needs more power and money to do its job.
This same unscrupulous drug manufacturer was the focus of a 60 Minutes broadcast on March 10, 2013.
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.
CBS News ignored House and Senate investigations that documented the FDA's egregious failings in this matter. CBS instead allowed the FDA to blame this catastrophe on lack of regulatory authority over compounding pharmacies.
U.S. 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 that contain up to twice the labeled dose. Manufacturing plants with rusty tools, mold in production areas and — in one memorable case — a barrel of urine."
The New York Times emphasized that these were not reports about the injectable drug maker that caused dozens to die from fungal meningitis. These quality lapses were found at large drug companies whose names are familiar to many Americans.
When these problems were discovered, the FDA sent out "warnings" to these companies. Instead of fixing the problems, many of these drugmakers decided it was cheaper to simply discontinue making the drug(s). The result was severe shortages of the drugs cited by the FDA. This opened up the market for disreputable companies to make these 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 result in dreadful sickness and sometimes death.
A drug factory made large quantities of a steroid (methylprednisolone) that was injected into the joints and spines of aging humans in chronic pain. It provided immediate but temporary relief.
The problem was this drug was contaminated with a black fungus that easily infected those who were injected with it. 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. It was not until hundreds fell ill and scores died that the FDA took meaningful action (in 2012).
How the FDA bungled investigation
The name of the company that made the fungus-laced injectable drug is New England Compounding Center (NECC). It pretended to be a compounding pharmacy, but instead functioned as a large drug factory.
The FDA claims that it lacks adequate regulatory authority over compounding pharmacies, but the FDA's inspection of NECC in year 2002 revealed problems with record keeping, sterility, and other issues. That same year the FDA informed the Massachusetts State Board of Pharmacy of an adverse reaction to methylprednisolone, which is the same drug that in 2012 caused the fungal-meningitis outbreak.
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, which may not have prevented the problems since FDA-registered drug makers were later found to have similar unsanitary facilities.
The FDA and Massachusetts State Pharmacy Board's most blatant failure in this matter was to uncover horrific conditions inside NECC … and take no practical steps to enforce safety compliance before tragedy struck.
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.
NECC did not 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.
In addition, NECC did not test the manufacturing equipment used to sterilize injectable drugs on a timely basis.
The result of a multitude of quality lapses was injectable vials that contained black matter inside, which turned out to be the fungus that caused 48 deaths.
FDA inspects after catastrophe
After hundreds had fallen ill from fungal meningitis, the FDA conducted a thorough inspection of NECC's drug factory.
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.
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. In fact, FDA inspectors found greenish-yellow discoloration inside the one cleaning autoclave and a tarnished discoloration inside another.
NECC turned off its air conditioning in "clean rooms" from 8 p.m. to 5:30 a.m., which is improper because failing to keep clean rooms at low temperature and low humidity provides a fertile environment for fungal growth.
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.
Furthermore, "clean rooms" used to make injectable drugs had been identified by NECC's own staff as detecting bacteria and molds in January 2012, but the FDA could find no evidence that the company acted to fix these lethal problems.
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 methylprednisolone injected into their spines and joints.
Congress cites FDA failure
The House and Senate held oversight hearings on the NECC tragedy that sickened over 700 and killed 48 people.
Congress wanted to know why the FDA didn't do more to prevent the production and sale of the tainted steroids.
As anticipated, the FDA claimed that it didn't have enough authority to regulate pharmacies that compound drugs. FDA Commissioner (Margaret Hamburg, M.D.) warned that if Congress doesn't strengthen legislation, another similar tragedy is inevitable. Dr. Hamburg stated before the House committee:
"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 irrefutable documentation that the FDA and the Massachusetts State Board of Pharmacy 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 the 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 NECC, which distributed tens of thousands of doses of contaminated steroids.
Dr. Hamburg was lambasted by House Committee members who stated:
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."
Senate more harshly critical of FDA
The day after the House hearing where the FDA asked for more authority, a bipartisan staff of the Senate Health, Education, Labor and Pensions Committee issued a report detailing how federal and state regulators knew nearly a decade ago of serious safety concerns with the NECC tied to hundreds of meningitis cases, but failed to act decisively. The report concluded that "bureaucratic inertia appears to be what allowed a bad actor to repeatedly risk public health."
While acknowledging the lack of clarity in what the FDA's role should be in regulating compounding pharmacies, the Senate cited plenty of evidence that the FDA should have taken action against NECC, which clearly was functioning as a drug factory.
The Senate investigators wrote, "Both federal and state regulators were well aware that NECC and its owners posed a risk to the public health" and "repeatedly failed to demonstrate that the company could safely compound sterile products."
One senator told of an elderly patient from her state whose mouth had become infiltrated with mold that "she had to be swabbed free of black fungal matter before she died."
The Senate report uncovered an internal FDA memo in 2003 that concluded there was "potential for serious public health consequences if NECC's compounding practices, in particular those relating to specific sterile products, are not improved."
The Senate confirmed that NECC-produced methylprednisolone "had previously been a suspected cause of at least two cases with bacterial meningitis-like symptoms" in 2002, leading to an FDA inspection … with no meaningful action taken.
Most senators expressed skepticism that the FDA could effectively use widened authority under any new law, one stating "the FDA has failed to use its existing authority," with another stating, "This has been going on since 2002 … It took all this time, and nobody did anything."
Regrettably, some senators still believe that giving the FDA more tax dollars will solve these issues of bureaucratic incompetence and mismanagement.
At the Senate hearing, FDA Commissioner Margaret A. Hamburg conceded:
"Perhaps we should have been more aggressive," referring to the FDA's failure to inspect NECC and follow up on the 2006 warning letter. "There was a lot of debate within the agency about whether to proceed."
Senators repeatedly questioned the FDA's sending NECC a warning letter in 2006 and a letter in 2008 saying that it planned to inspect, but not following through until after the fungal meningitis outbreak occurred in late 2012.
What Congress overlooked
What was not discussed in congressional hearings was the FDA's history of abusing and misusing whatever authority that Congress gave it.
For example, when the FDA first discovered problems at NECC (in 2002), it chose to direct its limited resources to prosecuting a man named Jay Kimball who sold a drug (liquid deprenyl) that harmed no one.
In 2006, while FDA did not think it needed to stop NECC's lethal manufacturing practices, it somehow found the time to censor claims by cherry growers that cited scientific studies on their website showing cherries conferred health benefits.
What few understand is how the FDA has abused its authority in a discriminatory manner. The new "authority" the FDA is seeking would enable the agency to pick out small, well-run compounding pharmacies and regulate them out of business using minor technical arguments that have no bearing on safety.
How much more FDA failure will Americans tolerate?
In 1906, a book called "The Jungle" was published that described appalling conditions inside America's meat packing industry. The revelations in this book resulted in the establishment of federal laws that mandated standards of strength, purity and quality of foods and drugs.
Conditions inside some of America's drug factories are eerily similar to those described in "The Jungle," yet the FDA has been around for more than 100 years! How much longer is the public expected to wait before the FDA effectively spends its $4 billion annual budget on real consumer protection, as opposed to threatening walnut and cherry growers for claiming health benefits for their foods?
No matter how many times the FDA fails to protect consumers against contaminated drugs, there are no calls for meaningful reform.
Instead of recognizing FDA ineptitude, cries ring out to give the FDA more money and power … as Americans perish from contaminated drugs the FDA should have stopped.
No free market!
What the public doesn't yet understand is that contaminated drugs are the result of draconian regulations that limit free market competition. By restricting drug factories to only those overseen by incompetent bureaucrats, the inevitable result will be shortages, poor quality and high prices.
One of the challenges in dealing with the NECC catastrophe is that there may be new shortages of injectable drugs because there are not enough drug factories in the U.S. to meet patient demand. Shortages create opportunities for unsavory companies to dump even greater amounts of overpriced and contaminated drugs into the bodies of unsuspecting victims.
This kind of problem would not continue in a free market, but ever-increasing regulations are exacerbating the problems of drug shortages, deadly manufacturing practices, and obscenely high prices.
We will re-publish this response to the FDA's deceptive tactics aired last night on 60 Minutes in greater detail later this year in Life Extension Magazine®.
I thought it critical to alert members immediately about this misleading propaganda as it may influence policy makers into giving the FDA more authority. The facts clearly show that the FDA failed to use the power it already has to stop contaminated drugs from poisoning the American public.
For longer life,