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 safely 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:

“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 U.S. Food and Drug Administration, the answer here appears to be,     ‘Yes’.”

“You can take a regulator to a     problem but you can’t make him regulate.”

“It’s an absolute tragedy without     any question that 32 people have died.”

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,

William Faloon