Health
2:00 am
Fri January 25, 2013

'These people are murderers': The drug network behind a deadly outbreak (Part 2)

Hear the final installment in Michigan Radio's series on the fungal meningitis outbreak.

This is the second in a two-part series. Click here to hear part one.

More than 240 people in Michigan are sick with fungal meningitis after receiving contaminated back pain injections. 

Now, the victims want justice. They’ve spent weeks in the hospital, racking up massive medical bills.

Those are the lucky ones: 15 Michiganders have died so far in this epidemic.

The obvious culprit here is the Massachusetts drug clinic that allegedly made the mold-infected drugs that were shipped to doctors across the country.

But it took a whole pain-treatment network to make so many people sick.   

"These people are murderers." 

Anita Baxter is pissed. She keeps it under wraps, because she’ has to plan her wedding, finish her master's degree in biology, and keep it together for her two younger brothers. They’re having a rough time after their mom died last September from fungal meningitis.

The only way you can get Baxter to really let it out, to raise her voice or get angry, is by talking about the Massachusetts facility that made the contaminated drugs that killed her mom.

“It’s not fair that people are greedy and it’s killing people! It’s that or incompetence," she says, and from what she’s heard so far, she’s leaning towards greed.

“It’s got to be greed because why else would you ignore everything you’ve been taught, the difference between sterile and not sterile? I don’t even care about the lawsuit. These people are murderers, and they need to go to jail, not lose their money,” Baxter said.

There are plenty of people who agree with Baxter. She’s one of several families and patients suing the New England Compounding Center (NECC), the facility that allegedly made the contaminated injections that were then given to 14,000 people across the country.

“The place was disgusting. They had a rodent problem.”

Health inspector reports about the NECC read like something out of a mad scientist story.

Officials found drug vials with visible black particles floating in the liquid medications. 

Water was leaking from the boiler through the walls, which could explain how a deadly fungus got into those drugs.

Alyson Oliver is a Michigan attorney who flew out east to do her own inspection of the center. She’s representing several clients involved in the lawsuits.

“The place was disgusting," Oliver says. "I mean, they had a rodent problem because they had mice traps around the facility. And we were greeted, when we went and did the inspection, with a little guest in one of the traps.”

Oliver is an easy person to like, with a warm, direct gaze, long blonde hair, and minimal makeup - just a touch of blue eyeliner that seems fun and bright. You can imagine drinking wine with her and talking about trashy reality shows.

But none of that takes away from one simple fact: Oliver is out for blood.

She doesn’t just want to take on the New England Compounding Center.

She’s doing something that no other lawyer is attempting (at least, that no other lawyer is willing to go on the record about yet; I did talk to one lawyer who says they’re biding their time):  she wants to go after the pain clinics in Michigan that injected the moldy drugs into about one thousand patients.

She thinks she’s got a strong case. But to break it down, it needs a bit of explaining.

“[Doctors] have to do due diligence. It's their duty. And they failed.”

Compounding centers, including the New England one, are supposed to be like modern day apothecaries. Don’t worry if you’ve never heard of them before now – no one has, at least outside of the world of pharmaceuticals. Actually, that’s part of the problem.

Basically, the way compounding centers are supposed to work is, a doctor calls up a compounding center and says, “Hey, I've got this six-year-old patient, could you mix a little strawberry flavoring into this cold medicine so I can get him to take it?” Or maybe, “I’d like to have this pill turned into a cream, because old Mrs. Smith’s digestion is a little sensitive these days.”

It's typically small potatoes stuff. In fact, because compounding centers are only allowed to fill individual prescriptions of generally common drugs, their lobbyists have been able to hold off the Food and Drug Administration from regulating them. After all, why should the FDA worry about these little guys?

Now by this point, you’re probably thinking, “Hey, sounds like a fabulous loophole if somebody wanted to say, oh, produce thousands and thousands of shipments of back pain injections and sell them across state lines at cut-rate prices! After all, there’s no FDA to jack up your overheads by making sure that, you know, there’s no deadly fungus in those drugs.”

Actually, that’s probably an unfair characterization. It’s not likely that the New England Compounding Center intentionally set off on a calculated, regulations-breaking, illegal-drug manufacturing spree. That kind of thing would have gotten noticed before now.

What’s more likely is that the NECC’s business started booming – and pretty soon, they didn’t have time to require every single doctor to send in individual prescriptions for each vial of drugs. And then, in all that rush and bustle, it’s a gradual slope to letting a boiler leak just a little, maybe set up a few mice traps rather than call an exterminator … you get the picture.  

This is when lawyer Alyson Oliver comes back into the picture. She argues that Michigan doctors share in the blame for this epidemic, precisely because they were ordering bulk shipments of medication from a compounding center – a definite regulatory no-no.

How much is “bulk?” The Brighton Pain Clinic was able to give out some 830 injections of the contaminated drugs over just two months, according to the company’s Web site.  

“I don’t think it’s ok for a doctor or a hospital or a pain clinic to just get their drugs from anywhere,” Oliver says. “I mean they can’t go down the street to the guy on the corner and say it’s ok. They have to do due diligence, I mean it’s their duty. And they failed.”

“We don't shake hands no more. We hug.”

Oliver says maybe nobody paid too much attention to where the meds were coming from, because they were making a really good profit on a wildly popular drug.

Pain clinics could get the back pain shots from the New England Compounding Clinic for about $5 to $10 a pop, according to an office manager at one of the Michigan clinics. She didn’t want us to use her name, nor the name of her clinic.

Meanwhile, insurance reimburses those doctors between $200 to $400 for each shot, according to multiple reports, as well as that same clinic office manager.

On top of that, several studies say there isn’t enough evidence that these back pain shots actually work.

Add it all up and it doesn’t look very flattering for the doctors at these private pain clinic.

But then, you talk to one of their patients.

I called J.R. Mazure, an inpatient who’s been in the hospital with fungal meningitis unit for 52 days. His whole world, he says, has shrunk down to what he can see out his hospital window – mostly a parking lot, a few trees.

I tell him about the rap against the local pain clinics. I tell him, you've got to be feeling some kind of anger, right? Wanting…  

“Some sort of revenge or something?” he interrupts. “No. There was never even a that of thought.”

Mazure says he got regular back pain injections at the Michigan Pain Specialists in Brighton (which patients and doctors call the Brighton Pain Clinic), the same place that injected more than 800 people in two months.

I called and left voicemails with the Brighton Clinic multiple times. I emailed Mazure’s doctor. I never got a response.

But Mazure says he would never, ever  think to blame his doctor.

“He stops by at least twice a week to see me,” he says.

When I ask him what that’s like, what do you talk about the first time your doctor visits (meaning, what the heck do you say to the guy who injected you with the contaminated drugs that put you into this hospital), Mazure isn’t fazed.

“Well, we don’t shake hands no more. We hug. You know, he’s in it as much as anybody. He’s trying to figure this out, ” Mazure says.

"OK," I ask, "but what did he tell you about how this happened?"

“Mm, not much. We didn’t really get into that,” Mazur said.

But let’s get into that. Three different patients interviewed said basically, "I love my pain doctor, I’ve been seeing them for years, we’re friends. I would never blame them for this."

“I had no idea, and I know my partners had no idea.”

There was one pain clinic doctor who would talk on the record: Dr. Steven Andriese of the Neuromuscular and Rehabilitation Associates of Northern Michigan.

Even though he’s got a patient waiting out front, he gives me a generous thirty-five minutes of questioning, and he patiently walks me through his experience.

Does he hear from patients who want to assure him that they don’t blame him for any of this?

"Yes," he says.

Dr. Andriese seems like a pretty stoic guy, but he takes long pauses here, presumably reining in his emotions. He’s learned “so much about the human spirit,” he says, from the kindness his patients have expressed towards him. They call him up, just to make sure he’s doing okay.  

As for how his clinic could break regulations by buying bulk medications from a compounding center, Dr. Andriese say he never had an inkling such a regulation even existed before, at least before this outbreak made it front-page news.  

“For me, I had no idea, and I know my partners had no idea, that compounding centers couldn’t send out bulk,” Andriese said.

But that ignorance feels like a red flag. Patients assume in terms of ordering this stuff that somebody knows where they’re supposed to get bulk medications, and where they’re not.

Dr. Andriese sighs. “Right. And then the second part of that is, do physicians know where they’re supposed to get bulk, as opposed to individual medications? I didn’t know before this. And I would guess that’s not generally known by physicians, either.”

As hard as it may be to believe, Dr. Andriese’s experience bears this out. He points out, quite accurately, that plenty of big-name hospitals and pain clinics in some 23 states were ordering bulk medication from the New England Compounding Center.

If they were trying to break regulations, they certainly weren’t being very sneaky about it. Everybody was doing it. The New England Compounding Center was openly hawking their wares at every pain conference they could attend.

I asked Dr. Andriese about the studies that question whether back pain injections are truly effective – and that insinuate that, rather, they’re just an easy paycheck for doctors.

Dr. Andriese says the studies that make those claims aren’t looking at clinics like his. He says he’ll always advocate a patient trying physical therapy before getting steroid injections, or even losing weight, getting some exercise – anything before putting an epidural in their spine.   

“Maybe somebody that just knew that study and judged me for using epidurals would say, 'Oh he’s over-treating,'” Dr. Andriese says.  “That’s just not true. Because I know that epidural shots do work, and I know that people in less pain make better overall progress in responsibility.”

No apologies, but maybe some change.

Before we hang up (and at this point, Dr. Andriese’s poor patient must have been waiting for a good half hour), I ask him if he believes pain clinics like his bear any responsibility in this epidemic.

"No," Dr. Andriese says. "I don’t."

I know he’s got to get going, but I can’t help pushing him on this – none? Even after it’s come out about the bulk medications? Couldn’t you guys have kicked the tires on that a little more?

But Dr. Andriese sticks to his guns. How was he supposed to be the one doctor who thought, "hey, maybe the way major hospitals and hundreds of clinic are getting their drugs is actually against regulations?"

And maybe the reasons why his answer feels so hard to hear, is because at this point, you just want someone to say, “I’m sorry.”

It makes you think about how Anita Baxter must feel, to have lost her mom to this disease so suddenly, and no one has told her “I’m sorry.”

But Baxter is also a biologist in graduate school, so she thinks like a scientist. She says, and Dr. Andriese agrees, that they hope one big change comes out of this tragedy: stronger, national regulations for compounding centers.

Lobbyists have been fighting tougher regulations on these centers for years, and so far, they’ve been wildly successful. But this epidemic has fueled stronger political will for new regulations. 

Of course, many compounding centers - including those who spoke with Michigan Radio for this story - say they're just their mom-and-pop operations, filling an important need in the modern medical landscape. 

But if just one compounding center can take advantage of lax oversight to expand their business across state lines, and in total disregard of regulations, it’s hard to be completely certain about where our medicine comes from.