Health
4:24 pm
Thu January 31, 2013

Fungal meningitis outbreak: a doctor responds to our series

We're getting a lot of feedback about last week’s series on the fungal meningitis outbreak in Michigan. Some of you loved the series. Some of you, not so much.

But there is one response that we want to share with you. It’s from Dr. Stephen Andriese, whom our reporter Kate Wells interviewed and quoted in the piece.

Dr. Andriese works at Neuromuscular & Rehabilitation Associates of Northern Michigan, which received and administered some of the contaminated drugs that led to this outbreak.

Below, we’ve included his email, and we’re posting it here (with his permission, of course) because we think it brings additional depth and insight to this complex and tragic epidemic.

Just as we value Dr. Andriese’s input, we also want share the email Kate Wells wrote back to Dr. Andriese (again, with permission from Kate and Dr. Andriese). They’re both long, and they delve into areas we didn’t have time to cover in the original stories, but we hope you’ll take a few moments to read through them.

And as always, we want to know what you think. Leave a comment below, or shoot us an email.

- Michigan Radio 

Monday, January 28, 2013

From: Stephen Andriese

To: Kate Wells

This letter is intended to provide you with information which corrects some key facts that were in the story, 'These people are murderers': The drug network behind a deadly outbreak (part 2). The first correction is the term "pain treatment network." My practice is not part of a pain treatment network. We are a private practice of physiatrists treating patients with a range of problems including pain. We are also not a pain clinic.

The second, and much more significant correction to what you reported is that there is no or very little profit from medication that we order for our facility to administer to our patients. Vials of steroid, for instance, cost approximately $7-15. Average reimbursement is approximately $10 from Blue cross and medicare. When we bill for a procedure, such as doing an injection, the reimbursement is based on the procedure performed. So if you inject a knee with steroid or Synvisc, we are paid the same (procedure fee). The reimbursement for the medication itself just covers our cost to stock that medication.

And to, perhaps, the heart of your story, I offer this. Due diligence or as you say "kicking the tires a bit more on this one" is toward the goal of trying to provide the best possible treatment to patients. As I explained in our interview, we bought from NECC because we wanted to provide a preservative-free steroid for epidural injections. We looked at the studies of arachnoiditis and the possible links to preservative. We've also looked at the studies which refute the original studies. We concluded that a preservative-free product was the safest possible medication. The only way to get preservative-free product is from a compounding pharmacy. Buying from NECC was precisely the conclusion we came to from due diligence. Many such pharmacies exist and provide much-needed product to doctors and hospitals.

Like you said in your article, no such customer of bulk compounded product was trying to buy such product on the sly. If the product is being legally sold, the onus is on those that regulate the industry to oversee such product and how it is sold. There's nothing about a compounding pharmacy, selling in bulk, which implicates that they would sell contaminated product. We have to trust those that manufacture medications, whether Pfizer or the local pharmacist who does compounding or the big compounding pharmacy will all providing a sterile product. We also have to trust that they are regulated properly. No amount of due diligence could have led to the conclusion that they were providing a tainted product. If it is legal to purchase it, and it is better for my patients, it is the optimal choice. I'd argue that the clinics that ordered from NECC were reflecting greater due diligence because they read the literature and sought out a preservative-free steroid product.

And finally, there is a big difference between me saying to an interviewer that, "yes, I am partly responsibile for this crisis, I'm sorry" and saying "I'm sorry" to my patients which I do everyday. I am so sorry. I have never felt more responsible to people, other than my family, than I do my patients that I infected. I see them unable to walk because of pain from the infection. I see terrible side effects of the medication, legitimate worry about whether there may be long-term sequela, co-morbities of neurologic impairment, semi-emergent orthopedic surgeries performed that require 3 months of not being able to put weight through their leg. I have been involved in an unprecedented epidemic of man-made disease.

I have devoted my career to promoting wellness and quality of life to the point where I go home with headaches from the strain of lengthy conversations over and over again about all the things people can do to optimize their health. To have administered disease-causing medication to the very people I'm working so hard to make healthy is absolutely devastating. I write this to you because it adds to how awful the situation is if people misunderstand that doctors used this product to profit themselves, could have looked into it better and avoided it, and knowing all that, still don't say their sorry.

Steve Andriese

Now for Kate's response. Her comments are italicized and Andriese's are bold for easier reading.

Tuesday, January 29, 2013.

From: Kate Wells

To: Stephen Andriese

This letter is intended to provide you with information which corrects some key facts that were in the story, 'These people are murderers': The drug network behind a deadly outbreak (part 2). The first correction is the term "pain treatment network." My practice is not part of a pain treatment network. We are a private practice of physiatrists treating patients with a range of problems including pain. We are also not a pain clinic.

Dr. Andriese, you’re absolutely right that your practice is privately owned, and treats a wider range of physical problems beyond just pain.

 When searching for a way to describe the growth of the pain-treating, often private practices around the country, I used the term “network” – but maybe “industry” would have been more accurate. Part of that decision was a desire to illustrate, even to those unfamiliar with the industry, how the actions of one compounding center in Framingham, Massachusetts could ripple across the country so dramatically. And I wanted a catch-all term for these separate practices when talking about the regulations, trends, and research behind the increasing use of this treatment (the back pain injections).

Also, I used the description “pain treatment” because one frequent commonality across all these separate practices is that it’s their pain treatment procedures that get front-page billing. For instance, your practice, the Neuromuscular & Rehabilitation Associates of Northern Michigan, is described on its website as “Specialists in Pain Management and Mobility.” And under the section “Services,” at least three of the five conditions listed are pain-related: “Neck or low back pain…Carpal tunnel syndrome…Pain, numbness, or limited mobility.”

I’m sorry if I used the word “clinic” incorrectly – maybe it has a more specific, limited meaning in the medical community than I’m aware of? I was using it as just a general term, meaning “A facility (such as a hospital) for diagnosis and treatment of outpatients; A group practice in which several physicians work together,” which is how “clinic” is defined on Merriam-webster.com. Since one of our goals at Michigan Radio is to talk to our audience in a conversational way, I’m sure I probably used terms and descriptions that would drive doctors nuts, but the goal is to be understood by the listeners.  For my own knowledge, is there a more accurate description – maybe just “practice?” If I misused the term, it was certainly unintentional.     

The second, and much more significant correction to what you reported is that there is no or very little profit from medication that we order for our facility to administer to our patients. Vials of steroid, for instance, cost approximately $7-15. Average reimbursement is approximately $10 from Blue cross and medicare. When we bill for a procedure, such as doing an injection, the reimbursement is based on the procedure performed. So if you inject a knee with steroid or Synvisc, we are paid the same (procedure fee). The reimbursement for the medication itself just covers our cost to stock that medication.

Again, you’re absolutely correct here: Medicare and private insurance will cover roughly $10 or so of just the vial of drug, such as prednisone, by itself.

But the reimbursement for the actual procedure (injecting the drug as a treatment for back pain) is what I was reporting on and published in this story. When I spoke with Blue Cross Blue Shield of Michigan, they informed me that they cover back pain epidural injections in full, depending on what level of insurance a patient carries. At the lowest levels, however, and if you go out of network, the deductible can be up to $2,000 for this procedure.

What the procedure costs ranges wildly, depending on what source you’re using. Dr. Steven Cohen, of Johns Hopkins University School of Medicine says the procedure ranges from $500-$700. Healthcare Bluebook estimates the cost for the same procedure in Michigan is about $436. For what it’s worth, The New York Times has reported that it can range from $600 to $2,500 for the procedure, though I didn’t find any facilities that were charging as much as that.

Actually, the numbers I ended up using in this story were on the lower side of this range, and came from Laura Alexander in your office. She’s the one who clarified for me that the $10 reimbursement is just for buying the drug – but insurance will reimburse the facility between $200 (for the average Medicaid patient) to $400 (for a privately insured patient) for the actual procedure. I called her again this morning just to make sure we were on the same page.

I do think, though, that I could have made this distinction clearer in the story. I guess I’m still unsure if this distinction is critical for our general audience, especially with the time constraints and the complexity of the story as it is.

 However, I do think there’s room to clarify that the physicians and staff at these facilities, including Laura, assert that the reason these procedures can cost more is because the equipment, physician’s time, reserving lab space, hiring qualified and specially trained doctors, as well as general overhead are all factors. I think delving deeper into those details would give our audience a more nuanced understanding of this process, and for that I was in the wrong.

Of course, the other side to that argument was presented in The New York Times article published on November 17, 2012: “How Back Pain Turned Deadly.” Among other things, reporter Elisabeth Rosenthal writes,

“Spinal injections…have been fostered and promoted by the rising number of pain clinics and pain specialists…who invest in extra training to learn procedures like spinal injections.”

Rosenthal goes on to quote Dr. Scott Forseen of Georgia Health Sciences University:

“‘There used to be only a small number of people who did this, but that’s gone way up, and reimbursement has gone up too.’…The number of spinal injections given in any geographical area correlates better with the number of local specialists trained in the procedure rather than the amount of back pain [according to Dr. Janna Friedly at the University of Washington].”

“The shots…are often dispensed at for-profit pain clinics owned by the physician holding the needle. ‘There’s a lot of concern about perverse financial incentive,’ Dr. Friedly added.”

Again, Dr. Andriese, I am in no way whatsoever trying to suggest that your facility is anything other than an upstanding, conscientious, painstakingly careful practice. From what I’ve learned through you, Laura, and your website, I genuinely believe it is all those good things.

 I’m just trying to illustrate that as my editors and I debate about what we should include in a piece, and what has to end up on the cutting room floor, a break-down of this procedure’s cost was left out. Not because it’s not important – and I’m freely willing to admit it is, and even that it should have been included – but that getting into who says what about the reasons behind these costs is a longer and more complicated debate. 

And to, perhaps, the heart of your story, I offer this. Due diligence or as you say "kicking the tires a bit more on this one" is toward the goal of trying to provide the best possible treatment to patients. As I explained in our interview, we bought from NECC because we wanted to provide a preservative-free steroid for epidural injections. We looked at the studies of arachnoiditis and the possible links to preservative. We've also looked at the studies which refute the original studies. We concluded that a preservative-free product was the safest possible medication. The only way to get preservative-free product is from a compounding pharmacy. Buying from NECC was precisely the conclusion we came to from due diligence. Many such pharmacies exist and provide much needed product to doctors and hospitals.

Like you said in your article, no such customer of bulk compounded product was trying to buy such product on the sly. If the product is being legally sold, the onus is on those that regulate the industry to oversee such product and how it is sold. There's nothing about a compounding pharmacy, selling in bulk, which implicates that they would sell contaminated product.

 We have to trust those that manufacture medications, whether Pfizer or the local pharmacist who does compounding or the big compounding pharmacy will all providing a sterile product. We also have to trust that they are regulated properly. No amount of due diligence could have led to the conclusion that they were providing a tainted product. If it is legal to purchase it, and it is better for my patients, it is the optimal choice. I'd argue that the clinics that ordered from NECC were reflecting greater due diligence because they read the literature and sought out a preservative-free steroid product.

I have absolutely no doubts about the care you and the other doctors at your practice took in researching possible risks of preservatives. It’s impressive and commendable. In fact, I recall from our interview that you decided to go with preservative-free steroids out of an abundance of caution, even though the studies about preservatives are often contradictory.

And my research thus far backs up what you’re saying about compounding centers being the only way to buy preservative-free steroids. That’s why I called up an Ypsilanti compounding center (who didn’t want their name used in the piece, at the risk that they would lose business from local pain clinics). They told me they are definitely capable of making these steroids without preservatives, although they said they could only sell them on an individual prescription basis, and that their cost would be up to twice what the NECC was charging.

I also agree with you that these compounding centers often fill a critical, overlooked need – which is why I said so in the online story.

But where it gets complicated is what, exactly, was generally known about the regulations regarding compounding centers, and when. That’s not just my question: it’s also being raised by regulators, lawyers, a grand jury in Boston, and hearings in both the U.S. House and Senate.

That being said, I think that as those questions are asked – not just of doctors, but of federal and state regulators, the Massachusetts Board of Pharmacy, and major hospitals around the country – it’s important to convey that with so many doctors buying these meds in bulk, it would be tough to conclude that they were knowingly breaking regulations. I strove to convey that in both the on-air and web piece.

I also think that more could be said about how the NECC bears significant responsibility in terms of 1) conveying consistently to their clients what their regulations were, and 2) making sure that they were staying within those regulations. I also think the Massachusetts Board of Pharmacy was too willing to make light of complaints about the NECC violating exactly those regulations.

 Again, it’s always a questions of how much can we throw at our audience before we’ve overwhelmed them? That’s not an excuse for simplistic reporting – in fact, it’s why my editors gave me the ok to do a two-part series, with a full seven minutes on air for each part (usually, even our longer stories are capped at four minutes). And because our story is focused on the debate here in Michigan, I stuck to arguments surrounding Michigan doctors and patients. 

One such argument is that those regulations about compounding centers weren’t secret – they were on the books, and the reason that these centers were not overseen by the FDA. I’m not saying that means doctors should have said “hey, let’s comb through every piece of regulatory information about compounding centers as a general industry before we make this purchase,” but because lawyers, as well as an investigator with the Michigan Board of Pharmacy, are criticizing these doctors for exactly this reason, that made it important to include in the story. Just as your response (that doctors really had no idea, and these regulations weren’t general knowledge) were equally important to present.

And finally, there is a big difference between me saying to an interviewer that, "yes, I am partly responsibile for this crisis, I'm sorry" and saying "I'm sorry" to my patients which I do everyday. I am so sorry. I have never felt more responsible to people, other than my family, than I do my patients that I infected. I see them unable to walk because of pain from the infection. I see terrible side effects of the medication, legitimate worry about whether there may be long-term sequela, co-morbities of neurologic impairment, semi-emergent orthopedic surgeries performed that require three months of not being able to put weight through their leg. I have been involved in an unprecedented epidemic of man-made disease.

I have devoted my career to promoting wellness and quality of life to the point where I go home with headaches from the strain of lengthy conversations over and over again about all the things people can do to optimize their health. To have administered disease-causing medication to the very people I'm working so hard to make healthy is absolutely devastating. I write this to you because it adds to how awful the situation is if people misunderstand that doctors used this product to profit themselves, could have looked into it better and avoided it, and knowing all that, still don't say they're sorry.

Dr. Andriese, this portion of your letter touches me deeply. I lay awake for a long time last night after your letter was forwarded to me around 11 pm.  I should have been more careful in the conclusion of Part II, and further clarified the emotional responsibility that this epidemic has meant for you. About this, let me say just two things:

1)            At the end of writing this piece, I kept coming back to our interview, and how I kept pushing you about responsibility even after you had clearly answered that question, just as you did above (i.e., as much as your whole heart goes out to these patients, you don’t feel practices like yours could have prevented this outbreak, much less bear responsibility for it).

 I’d like to think I don’t usually push an interview subject after they’ve fully answered a question. I wanted our audience to understand that aspect of this story – the frustration, anger, and emotional pain that you, patients, and their survivors feel about this completely preventable tragedy. The frustration that anybody who’s even learned the details of this story comes away with. And the best way I could think of expressing that was to just admit it: that I was frustrated, and emotional, and that it wasn’t because of your answers – it was because of the complete lack of responsibility being taken, whether by regulators, or the NECC, or the Massachusetts Board of Pharmacy when so many people had lost their lives.  

In writing the story, I thought that distinction came across to listeners: that I didn’t push you because I thought you were wrong, or that I didn’t think this tragedy was heavy on your heart. Rather, that I pushed you because this tragedy is infuriating, and that it’s part of the pain patients, survivors, etc. are experiencing.

2)            Lastly, because I was so struck by your own perspective regarding your patients, and how patient you’ve been in sharing your experiences and insights, and how difficult this whole mess has been for you, I wanted to set aside some space to describe it in the web version. That’s why I included this paragraph:

“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.” 

I still could (and should) have been clearer that you have, and still do, say “I’m sorry.” I see now that my writing may have allowed a reader or listener to mistakenly conflate “I’m sorry” with “I’m responsible.”

I want to tell you again how grateful I am to you for your letter. I have come away from this story deeply moved by the dedication, care, and outright love between doctors and patients involved in this epidemic here in Michigan. And I have the greatest respect for your expertise and insights, as well as your tremendous commitment to your patients. 

Thank you, Dr. Andriese.  

Sincerely,

Kate Wells