Horrific Conditions Inside Drug Factories

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

FDA: Failure, Deception and Abuse

My book titled FDA: Failure, Deception and Abuse was published in early 2010, but no one in Congress listened, and scores of Americans are dead because of the FDA’s egregious ineptitude in the NECC fiasco.

 

 

 

 

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.”

Senate Harshly Criticizes the FDA

 

The day after the November 2012 House hearing, where the FDA asked for more authority, a bi-partisan staff of the Senate Health, Education, Labor, and Pensions Committee issued a report detailing how federal and state regulators knew nearly a decade before of serious safety concerns with the pharmacy (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.”^19,20

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.”¹⁹

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 .”¹⁹

The Senate confirmed that methylprednisolone produced by NECC “ 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.¹⁹

Most Senators expressed skepticism 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.”²⁰

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.”²⁰

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.^19,21

CBS News Enables FDA to Temporarily Deceive Public

On March 10, 2013, CBS News’ 60 Minutes aired an emotional broadcast about the NECC tragedy that included interviewing victims who suffered horrific illnesses, along with family members of those who died.²²

60 Minutes accurately told this story about NECC-contaminated drugs that caused 58 deaths and over 700 serious illnesses.¹

What 60 Minutes omitted was the fact that the FDA knew about this disaster-waiting-to-happen, but failed to stop it until Americans started dying in 2012.

FDA officials were given free rein on 60 Minutes to blame this catastrophe on a lack of regulatory authority. As you’re learning here, the fault instead lies with bureaucratic ineptitude at the hands of the FDA and the state pharmacy board that permitted these lethal deviations in good manufacturing practices to occur.

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.

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 overlooked the House and Senate investigations that documented FDA’s egregious failings in the NECC matter.

FDA Says It Lacks Authority…

But FDA does have the authority. And it did in 2006, when FDA inspected and sent a warning letter in effect telling NECC to stop manufacturing certain drugs or face legal action.¹⁹

In 2006, the warning came because NECC (pretending to be a compounding pharmacy) was found, among other things, to have failed to verify if supposedly sterile drugs met safety standards.¹⁹

Move forward to 2012 and NECC was not only still operating, but was selling tainted drugs manufactured under horrifically unsanitary conditions.¹⁹ Where was the FDA? Why did they wait for Americans to die before doing their job?

Congress Strikes Back at the FDA

On April 16, 2013, the FDA was subpoenaed to appear before Congress to account for why more wasn’t done to protect the public against contaminated drugs made at NECC.^13,23

Congress wanted the FDA Commissioner to explain why she was not more forthcoming about the FDA failures during the House and Senate hearings held in November 2012.

According to the House Committee report on the NECC debacle:

• “The investigation revealed what FDA Commissioner Margaret Hamburg did not disclose during the November 2012 hearing: FDA received a litany of complaints about NECC and its sister company, Ameridose, right up until the 2012 outbreak.”¹³
• “These complaints were related to the safety and potency of NECC and Ameridose products, issues that the FDA failed to routinely, if ever, inform the state about.”¹³
• “After reviewing more than 27,000 documents, we found a dramatically different picture than the one painted by the FDA during our initial hearing in November. We now know that doctors, patients, providers, and whistleblowers tried to warn FDA for years that NECC and Ameridose were operating as manufacturers and marketing their products nationwide without patient prescriptions.”¹³
• “The FDA was also warned about sterility and safety issues with the companies’ products. Rather than do its job and protect the patients who were taking NECC and Ameridose drugs, FDA chose not to act.”¹³

The box below contains highlights from the House Committee report showing that FDA failures contributed to the NECC disaster and how the FDA tried to cover up their own ineptitudes.

What Congress Overlooked

What was not discussed in Congressional hearings was the FDA’s history of abusing and misusing whatever authority Congress gave it.

For example, when the FDA first discovered problems at NECC (in 2002), it chose to direct its resources to prosecuting a man named Jay Kimball, who sold a drug (liquid deprenyl) that harmed no one. Jay Kimball remains in prison.²⁴

In 2006, while the 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.²⁵

What few understand is how the FDA has historically abused its authority in a discriminatory manner. The new “authority” the FDA is seeking would enable the agency to pick out small, well-run pharmaceutical firms and regulate them out of business using minor technical arguments that have no bearing on safety.

GLAXO Pays $750 Million Fine for Quality Lapses

 

GlaxoSmithKline is the world’s 4th largest drug maker, with annual sales of nearly $46 billion and profits of almost $9 billion.²⁶

In July 2002, the FDA sent a warning letter about quality problems uncovered at one of GLAXO’s subsidiary manufacturers. The egregious problems, however, were not corrected despite additional FDA inspections that continued to turn up severe problems, including failure to safeguard against microbial contamination.²⁷

The FDA initiated a seizure action in 2005 to remove adulterated and improperly made drugs.²⁸

Horrendous problems persisted, however, until the Justice Department filed a criminal complaint against GlaxoSmithKline and stopped what could have been a human catastrophe.²⁹

In October 2010, GlaxoSmithKline agreed to plead guilty and pay a $750 million fine to resolve criminal and civil liability regarding the manufacturing deficiencies.²⁹

Glaxo’s Defective Drugs

 

The defective drugs, manufactured between 2001 and 2005, were Kytril, Bactroban, Paxil CR, and Avandamet.²⁹

Kytril is a sterile injectable anti-nausea medication used by cancer patients receiving chemotherapy or radiation. Bactroban is a topical anti-infection ointment used to treat skin infections. Paxil CR is the controlled-release formulation of the popular anti-depressant drug Paxil, and Avandamet is a combination of Avandia and metformin.

Avandia has since essentially disappeared from the market because of increased heart attack risks, though an FDA advisory panel recently recommended it be allowed to be prescribed to certain diabetic patients.³⁰

Years after FDA approval, Glaxo sent out a black box warning about increased suicide risks in users of Paxil.³¹

With the realization that cardiovascular disease is the leading cause of death amongst diabetics, and suicide a huge risk in depressed patients, the notion that the FDA approved drugs with these kinds of side effects borders on absurdity.^32,33 These lethal side effect issues, however, are irrelevant to the manufacturing lapses that occurred.

According to an employee who filed a lawsuit against Glaxo over these uncorrected defects, the water system was contaminated, the air system allowed for cross-contamination between products, the warehouse was so overcrowded that rented vans were used for storage, the plant could not ensure the sterility of intravenous drugs, and pills of differing strengths were sometimes mixed in the same bottles.³⁴ Although FDA inspectors had spotted some problems, most were missed.

Glaxo paid the $750 million fine and admitted that its subsidiary failed to ensure that Kytril and Bactroban finished products were free of contamination from microorganisms. It also admitted that its manufacturing process caused Paxil CR two-layer tablets to split, which the company itself called a “critical defect,” because potential distribution of tablets would not have any therapeutic effect and no controlled release mechanism. ³⁵

Glaxo admitted that Avandamet tablets did not always have the proper mix of active ingredients and, as a result, potentially contained too much or too little of the ingredient with the therapeutic effect.²⁹

Potential Lethal Impact of Glaxo’s Abhorrent Lack of Quality Control

One can only imagine the problems that would occur if a depressed individual took a powerful anti-diabetic drug like Avandia, which could inflict acute hypoglycemia. A former employee identified nine instances where the wrong pills were sold, including Avandia^® mixed in packages of over-the-counter antacids like Tagamet^®.³⁶

For chemotherapy patients who are immune compromised, they could have easily succumbed to an infection without their oncologists ever suspecting it was linked to the anti-nausea drug Kytril, which was not tested to ensure it was free of microbial contamination.

No Jail Time for Glaxo Executives

 

Glaxo denies that any patients were ever harmed by the adulterated drugs they distributed in the United States and also denied that these kinds of problems occurred at its other drug factories.

No one from Glaxo faced criminal charges. I again remind readers that Jay Kimball, who sold a clean product that harmed no one, remains in federal prison. One difference is that Jay Kimball had no money for an attorney and had to represent himself in court (or render himself insolvent defending against FDA’s prejudicial accusations). Pharmaceutical behemoths like Glaxo, on the other hand, spend virtually unlimited money on lobbyists and lawyers and have not faced personal criminal liability for the misdeeds they allowed.

Reputation in Lieu of Regulation

 

One reason why horrific quality issues occur at pharmaceutical companies is that few consumers know who makes their prescription drugs.

When your doctor writes a prescription, you take it to your pharmacy and usually get a brown-colored bottle with pills inside. Seldom is the manufacturer’s name stated on the bottle.

Drug companies can thus run their manufacturing facilities with reckless abandon with little reputational risk.

Dietary supplement companies, on the other hand, prominently state their name on the labels of their products.

In a more sensibly-regulated environment, better-operated pharmaceutical companies would prosper as their reputation for quality control became known. Unfortunately, today’s Orwellian regulatory structure has created utter chaos, with retail pharmacies not knowing which generic manufacturer is going to make which generic drug at any given time.

Since we established the Life Extension Pharmacy^™ six years ago, we have learned how dangerous the prescription drug marketplace has become, with counterfeiting, shortages, and quality problems more rampant than reported by the media.

We would prefer that pharmaceutical companies place a higher value on their reputation and instill better quality standards.

Instead, regulatory burdens are so cumbersome that quality control takes a back seat to pleasing bureaucrats who wield unbridled power, but lack the competency to recognize catastrophic problems as occurred with the contaminated steroids made by NECC.

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 of 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 had the authority to stop!

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 making to only those controlled by incompetent bureaucrats, the inevitable result will be shortages, poor quality, and high prices.

As I write this article, 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 US 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.

You’ll read in this month’s issue about the quality-control standards we at Life Extension insist on. Unlike those involved in pharmaceutical manufacturing, I and most everyone else at Life Extension consume these nutrients ourselves and would never tolerate the deplorable conditions that exist in certain American drug factories today.

For longer life,

William Faloon

Senate Bill Seeks to Restrict Consumer Access to Better Drugs!

A battle is raging in the US Senate over whether you will be able to continue to obtain medications that are often more effective and less expensive than what large pharmaceutical companies offer.

On April 16, 2013, the FDA was subpoenaed to appear before Congress to account for the contaminated drugs made at New England Compounding Pharmacy (NECC).

According to the Congressional investigative reports, this unscrupulous manufacturer was allowed to inflict this carnage because the FDA failed to do its job.

Instead of punishing the FDA for its appalling dereliction of duty, the Senate has introduced a bill giving the FDA more power to take away bioidentical hormones and other drugs that are safely being made at compounding pharmacies.

Large pharmaceutical companies are using the NECC fiasco as a ruse to give the FDA more power to stamp out lower-cost competition.

You can easily contact your Senators by logging on to Life Extension’s legislative action website lifeextension.com/lac and sending them a prepared email instructing them to oppose S.959. The provisions contained in S.959 give the FDA the authority to restrict and eliminate the bioidentical hormones upon which millions of women and men depend.

FDA failures have resulted in unprecedented numbers of contaminated drugs poisoning Americans. The absolute worst response to these catastrophes is to give the FDA more power when it utterly botched its job with the draconian authority it already has.

Please send an email alerting your members of Congress to vote NO on Senate bill 959 (S.959).

You can also phone your Senators at 1-877-762-8762 to let your voice be heard.

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