The brothers-in-law at the heart of the fungal meningitis investigation

The pharmacy linked to the nation's deadly outbreak of meningitis is owned by two brothers-in-law who brought different but complementary skills to the venture: One's a pharmacist, the other a risk-taking businessman who made his mark recycling old computers, fishing rope and mattresses. 

Now the New England Compounding Center and its practices are under scrutiny as investigators try to determine how a steroid solution supplied by the pharmacy apparently became contaminated with a fungus. The drug has sickened 205 people in 14 states, killing 15. Most of the patients had received spinal injections of the steroid for back pain.

NECC was founded in 1998 by Barry Cadden and Gregory Conigliaro as a compounding pharmacy, a laboratory that custom-mixes solution, creams and other medicines in dosages and forms that often are unavailable from pharmaceutical companies.

Cadden, who is married to Conigliaro's sister Lisa, had the medical know-how behind NECC, earning a pharmacy degree from the University of Rhode Island. In a 2002 newsletter, he wrote that compounding had rebounded, after falling off when pharmaceutical companies began manufacturing drugs in the 1950s and '60s, and could help patients with painful conditions that demand "novel approaches."

Cadden, 45, backed his belief in compounding with a 2005 donation of between $2,500 and $5,000 to the legal defense fund of the International Academy of Compounding Pharmacists. The group wrote in a 2009 brochure: "To continue to champion the cause of pharmacy compounding and contend with entities such as FDA, we must not only be equipped with fighting words, but fighting dollars as well."

Conigliaro, 46, is a Tufts University-educated engineer and a member of the Air National Guard, from which he retired as a lieutenant colonel in 2007. He started Conigliaro Industries in 1991.

The company contended that pretty much anything could be recycled, and it did so in creative ways.

Conigliaro and his father, also an engineer, developed Boston's Best Patch, a pothole-filling mix that included the plastic housing from discarded computers. The company's Plas Crete Wall Blocks combine cement, sand, water and recycled plastic. Conigliaro Industries also boasts that it figured out how to recycle up to 90 percent of a discarded mattress.

And when regulators ordered that lobster traps be fitted with ropes that sink to the bottom so that endangered whales would not become entangled, Conigliaro took the discarded plastic lines and resold them to recycling plants, according to the National Oceanic and Atmospheric Administration.

(Cadden's wife is also an entrepreneur, having received a patent in 2002 for a "pillow feeding sleeve" to aid breastfeeding mothers by lifting their babies' heads.)

Conigliaro's success at the recycling company was repeated at the compounding pharmacy, and in 2006, the partners started another pharmacy, Ameridose, which would eventually report annual revenue of $100 million — more than 10 times NECC's. Ameridose products haven't been linked to any problems, but the pharmacy in Westborough has ceased operations while state and federal authorities inspect it.

Cadden has surrendered his pharmacy license and resigned from Ameridose. Neither man responded to requests for comment; a company spokesman said they are focused on helping investigators in the meningitis outbreak.

Some pharmacists who have done business with NECC said they were blindsided by the crisis.

"A great company to work with, very responsive to our needs," said Joe Allessandrini, assistant vice president of clinical services at South Jersey Healthcare. "This is, as I'm sure you're hearing from other people, a shock to us."

State officials have inspected NECC at various times, most recently last March, following a complaint about the potency of a product used in eye surgery. The results of that inspection have not been released, and state officials said the complaint appears unrelated to the meningitis outbreak.

However, NECC was licensed only to fill individual patients' prescriptions, state officials said. Authorities said it may have been operating beyond its legal boundaries by shipping products for broad use around the country. Compounding pharmacies are more lightly regulated than pharmaceutical makers, and their products are not subject to Food and Drug Administration approval.

"The New England Compounding Center was masquerading as a compounding pharmacy so it could escape federal regulation when it was actually operating as a drug manufacturer," said Rep. Edward Markey, D-Mass., who sits on the Energy and Commerce Committee, which has jurisdiction over the FDA.

Ameridose is regulated by the FDA, and in 2008 an FDA investigator found problems with its records, procedures and testing of drug products. Among the issues: Finished drug products were shipped before the company received results of a 14-day sterility test, according to Inspection Monitor, a trade newsletter that covers FDA inspections. Representatives of Ameridose and FDA did not return calls for comment.

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"Ameridose is regulated by the FDA, and in 2008 an FDA investigator found problems with its records, procedures and testing of drug products. Among the issues: Finished drug products were shipped before the company received results of a 14-day sterility test, according to Inspection Monitor, a trade newsletter that covers FDA inspections. Representatives of Ameridose and FDA did not return calls for comment."

It sounds like authorities should pierce the ciorporate veil and charge the parties with murder, or at least, depraved indifference murder/manslaughter.

I am also wondering if the FDA followed up, or followed up properly, after the sterility test failings. Maybe they did then stopped-who knows with them. That agency has no teeth. I assume more details will come out on how this tragedy came about.

In the meantime, the bad news just keeps coming about the poor victims.

  • 4 votes
Reply#1 - Sun Oct 14, 2012 6:11 PM EDT

This is unprecedented - I can't imagine the immune system being able to deal with this injected into CSF. Breathing it's not so bad (unless major concentrated quantities - like shoveling hay with major growth) and you could probably eat/pass it with no problem, but spinal fluid is not supposed to get exposed to fungus so the body isn't set up to deal with it.

  • 4 votes
#1.1 - Sun Oct 14, 2012 7:43 PM EDT
Reply

Hmm... fungus tests are slow. A 48 hour report is usually given and then another after 14 days, and a final after 6 weeks. Someone introduced typically outdoor fungus into what should have been a sterile mixing area - like someone taking a smoke break and picking up mould spores on a picnic bench. SOMEONE knows EXACTLY how this happened. I assume investigators are looking for heavy concentrations of Exserophilum rostratum along with the more typical Aspergillus fumigatus, assuming the ratio of contamination in 50 vials was the same as confirmed identification from patients (10:1). Aspergillus is everywhere - Exserophilum is less common (in grass, ???) . I've studied mould for several years, do mould remediation in houses, and have been infected a few times (lungs - taking stuff to kill that now), but never had anyone inject fungus into my spinal fluid. Jeeminy - this sounds like something out of a Robin Cook novel.

  • 3 votes
Reply#2 - Sun Oct 14, 2012 7:37 PM EDT

Mitt Romney (aka - friend of corporations and deregulations) and NECC are both from MA....hmm....concidence?

Wonder how much they contributed to his campaign....?

yeah, I know, some would call me a troll, but I just found this to be quite interesting....

  • 4 votes
Reply#3 - Mon Oct 15, 2012 10:04 AM EDT

Jet-1092441 I'm sure that Mitt had something to do with the contamination!? How can you possibly think Mitt had anything to do with this????? Goes to show some real anal people always turn these kind of events into something political. Do you think there is no coruption in the Dem party????? The problem is there is coruption both parties but to blame this on politics??? Move to another country if you don't like it here.

    #3.1 - Tue Oct 16, 2012 10:50 PM EDT

    U move to another country. Whats a matter - didn't like Willard's Freudian Slips last night.

    • 1 vote
    #3.2 - Wed Oct 17, 2012 10:04 AM EDT

    I'm all for spirited debate around election time, but this goes beyond the pale.

    As tiredofineffectivegov. succinctly stated, Mitt Romney had nothing to do with this. Democrats--even staunch ones--have to agree with that.

    This was simple negligence done for the sole purpose of increasing profit. Those directly involved may even be Obama supporters for all we know now.

    If we're to fix this, let's kill the problem at its source and not waste time bickering over silly conspiracy theories based on nothing more than where a candidate hails from.

    My thoughts and prayers go out to the victims...and my hope is that this tragedy moves Federal and local governments--Democrat, Republican and Independent alike--to implement the means to ensure this never happens again.

      #3.3 - Wed Oct 24, 2012 10:49 AM EDT
      Reply

      This is the cost of doing business. Get use to it. Bad air, bad water so some lose their lives. Clean coal, global warming who cares. Just so we have cheap things, like our lives.

      • 1 vote
      Reply#4 - Mon Oct 15, 2012 7:07 PM EDT

      I hope this wasnt a government black op intended to shut them down.

        Reply#5 - Tue Oct 16, 2012 11:07 PM EDT

        I would think The last place you would put a medical business is next door to a recycling plant in the same building !!!!!

        I would look there for the contaminate

        • 2 votes
        Reply#6 - Wed Oct 17, 2012 1:06 AM EDT

        Forgot it was nbc

          Reply#7 - Fri Oct 19, 2012 9:46 PM EDT

          I love the comparison about the fungus being in grass that you walk on & SHOT into the SPINE as a simular situation. Very ignorant comparison at the least.

            Reply#8 - Sat Oct 20, 2012 1:19 PM EDT

            The two brothers in law that started the company should be injected with the steroids and locked in cages.

              Reply#9 - Sat Oct 20, 2012 9:40 PM EDT

              How can you not believe that a Romney administration would reduce the amount of oversight and regulation that would prevent more similar incidences to occur? A significant part of his speeches contain complaints about "over-regulation" of industry.

              • 1 vote
              Reply#10 - Sun Oct 21, 2012 12:57 AM EDT

              But remember, we need LESS regulation of industry. At least, that is what Republicans keep telling us, right? I mean, who cares if a bunch of people die because they get fungus injected into their spinal column? No big deal right? You can't have regulation--that might hurt profits!

              • 1 vote
              Reply#11 - Mon Oct 22, 2012 12:12 AM EDT

              They are nurderers and those who voted to deregulated the very strict phamacy laws in the last adminstration should be charbed including the president.

                Reply#12 - Thu Oct 25, 2012 11:07 AM EDT

                The State investigated them several times, including last March. Why did the State inspectors not find the huge fungus/mold infestation throughout the whole building? They're like - "Hey be careful going into the clean room, there's a big slick spot right in front of the door." I guess mold/fungus is not something they check for in a pharmaceutical drug manufacturing lab. The place doesn't sound like a lab, it sounds like a barn.

                  Reply#13 - Fri Oct 26, 2012 11:56 PM EDT
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