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How U student with MS came to doubt her neurologist’s motives

Maran Wolston, a 30-year-old graduate student in the University of Minnesota’s department of philosophy, has published a powerful first-person account about how a patient’s trust in a physician can be seriously eroded by the physician’s financial relationships with drug companies.

Maran Wolston
umn.edu
Maran Wolston

The paper, which appears in the December issue of the journal Health Affairs, describes the series of treatment recommendations she received from a Minnesota neurologist, the physician who initially diagnosed and treated her multiple sclerosis (MS) four years ago.

What Wolston didn’t know until late last year was that the neurologist had received hundreds of thousands of dollars in speaking and consulting fees from pharmaceutical companies that make drugs to treat MS.

Wolston and her editors do not name the neurologist in the paper. But her story offers more than a comment on the questionable actions of a single physician. Hers is a cautionary tale for all patients.

The first red flag
In a phone interview Thursday, Wolston, a gregarious young woman who grew up in the Twin Cities, told me that she first became concerned about the neurologist’s ties to industry — and how those ties might be influencing her care — when he recommended she enter a clinical trial he was overseeing.

“It was a bit of a red flag to me because here was a doctor who was recruiting his own patients to a clinical trial,” she said. On her next visit, after telling the neurologist that she didn’t want to enter the trial because of the experimental drug’s possible side effects, she asked him if he was being compensated for his work on the study. He said yes.

“I was kind of ambivalent about it at that time,” she said. She didn’t like the fact that the neurologist hadn’t volunteered his financial connection to the study when he had asked her to enroll in it. On the other hand, Wolston believed that having a physician involved with the development of new drugs for her disease might help her gain early access to breakthrough treatments.

A confusing source of support
But Wolston’s concerns about her neurologist’s financial relationships with the drug industry deepened a few months later, soon after he persuaded her to start giving herself daily injections of the MS drug Copaxone to slow down the progression of her illness. (She wasn’t experiencing any outward signs of her disease at that time, but new brain lesions — evidence that suggested the disease was progressing — had shown up on her latest MRI, her neurologist told her.) About a week into her use of Copaxone, Wolston received a phone call from a nurse who said she was with Shared Solutions and wanted to know how the injections were going.

“My neurologist had asked if he could give my patient information to Shared Solutions, and I’d agree, assuming it had something to do with my health insurance,” she writes in Health Affairs. “Soon I began to receive letters and packages from Shared Solutions, including directions for self-injecting, refrigerator magnets, a box for carrying Copaxone syringes on a plane, and invitations to MS education dinners.”

More phone calls followed — about one every three weeks. The nurses were always pleasant and helpful, but Wolston soon began to wonder who Shared Solutions was, particularly after a “peer mentor” from the organization, an MS patient who was also taking Copaxone, phoned her.

“It kind of weirded me out,” Wolston recalled. “She was even more enthusiastic than the nurses were. She told me to stay on the medication, to be strong.”

Wolston found the woman’s enthusiasm peculiar because she knew that the Copaxone injections were anything but pleasant. In Wolston’s case, large, painful welts were forming on her legs after each injection — welts that often forced her to use a cane.

Wolston decided to look up Shared Solutions on the Internet, and quickly learned that it was a subsidiary of the drug company that makes Copaxone. The discovery troubled her.

“It worried me that none of them had ever suggested that I discontinue treatment — or switch to another treatment — even after I reported that my injection site reactions were affecting my quality of life,” she writes. “Despite the fact that my neurologist insisted that I begin disease-modifying therapy, I was never contacted by him, his nurse, or anyone else in the neurology clinic with questions about how my Copaxone injections were going. The entire time I took it, the only people who checked in on me, troubleshot my initially imperfect injection techniques, and answered my questions were the nurses from Shared Solutions.

“Maybe I’m old-fashioned,” she adds, “but as a patient I felt that the party who should have been helping was my neurology clinic, not a division of a pharmaceutical company.”

Wolsted took herself off the drug — a decision her neurologist concurred with when she told him of it.

A question of allegiance
At the next — and last — appointment Wolston had with the neurologist, he strongly urged her to try Tysabri (natalizumab), a drug that is administered once a month through an IV. Tysabri has been shown to be effective in slowing MS progression in some patients, but it also (as Wolston learned when she researched the drug) has serious side effects, including the development of a potentially fatal brain condition called progressive multifocal leukoencephalopathy (PML) in patients with weakened immune systems.

This recommendation raised a final red flag for Wolston. “Although the previous drug regimen hadn’t worked for me, I didn’t appear to fit the protocol for the new one,” she writes. “And then there was the earlier suggestion about participating in a clinical trial at a time when treatment wasn’t necessarily warranted and the subsequent hand-off to Shared Solutions when I was taking Copaxone. Now, learning the dangers of Tysabri — including what I felt was a nontrivial number of deaths linked to it — I had serious questions about where my neurologist’s loyalties lay. Did his allegiance lie with the drug companies or with me?”

She turned once again to the Internet, this time to a Minnesota database that was set up by state law two decades ago to make drug company payments to physicians transparent to the public. (A similarly designed national “sunshine” law is supposed to be fully up and running in 2013 as part of the Affordable Care Act passed by Congress in 2010.)

What Wolston found in the database was “damning,” she writes. Her neurologist had earned more than $300,000 from drug companies between 2006 and 2008, which at the time were the latest years listed.

Among those companies was the sponsor of the drug that the neurologist was testing in his clinical trial, as well as the manufacturers of Copaxone and Tysabri.

Wolston never returned to that physician. “Having MS is difficult enough,” she writes. “The last thing I needed was to worry about whether my neurologist was acting in the best interest of the drug companies or in the best interest of me, his patient.”

“You expect a CEO or a public relations person from a Fortune 500 company to spin things a bit,” she told me. “But you don’t think that about doctors — that they’re spinning things or having conflicts of interest that could be impacting your care.”

And the conflicts of interest did impact her care. “It put my decision-making at a standstill,” she said. “I felt like I couldn’t make a decision about whether to go on a treatment or not. I didn’t know how much of the information I was getting was biased.”

Popping the question
Several months later, Wolston sat in the office of another Twin Cities’ neurologist. She had carefully researched his qualifications and background — research that had included checking the Minnesota database for any possible financial conflicts of interest. She hadn’t found any for this new neurologist, but she wanted to make sure.

So she asked him point blank if he had ever earned any money from a pharmaceutical company. “It wasn’t difficult, but after I asked it, I felt a little weird,” she said. “It was the look on his face when I asked him. He was really surprised.”

No, he told her. He had no conflicts of interest.

Wolston then asked if any other patient had ever posed that question to him.

No, he said. She was the only one.

You can read Wolston’s compelling story in full on the Health Reviews website.

Comments (7)

  1. Submitted by Dimitri Drekonja on 12/09/2011 - 09:23 am.

    Fascinating story- I look forward to reading the full article. I’m a bit surprised her new neurologist has never had a patient bring up the conflict of interest question- with the degree of mistrust much of the public currently has towards big institutions and science in general, this is something I actively talk about with my patients. I let them know that I have no stake in whether or not they take a certain medication/vaccine, and that I get no sort of kickback/bonus/reward for any prescribing habits. Perhaps I’m being overly cautious, but it seems to reassure people.

  2. Submitted by Thomas Swift on 12/09/2011 - 10:18 am.

    Another science-denier! Quick, someone call Don!

  3. Submitted by Norman Larson on 12/09/2011 - 11:23 am.

    Something else that I think should be investigated are the stand-alone surgery centers owned by the doctors who send their patients there.

  4. Submitted by Richard Leaf on 12/09/2011 - 02:58 pm.

    Multiple sclerosis is a complex and frustrating disease for everyone involved in the care and treatment. The patient’s affectation can range from minimal to acute impairment with most falling in a huge middle range of discomforting symptoms that limit daily activities to significant extent. The symptoms of MS are controlled with medications. Each patient has their own unique profile in that regard. There are numerous medications that vary in effectiveness depending on the patient. If one does not work another is tried. In the article preceding the patient Maran is talking about her experience with Disease Modifying Therapies which are expensive and uncomfortable treatments designed to slow disease progression. Here too some experimentation is required to find an effective product for the patient if possible. The odds for the patient to be a recipient of such an outcome is lower than 50%. None of the DMT are a cure and there is none at this time.

    The neurologists being compensated by the drug companies with DMTs have practices with great numbers of MS patients they track. The doctor gauges the effectiveness of treatment for an individual just as they would for symptom management. It is possible a neurologist could develop a bias towards a certain product based on financial remuneration, but somewhat unlikely on the basis of state of the art treatment procedures.

    I am an MS patient diagnosed over 23 years ago and witness to many stories from others with MS that I have encountered as a volunteer peer counselor, support group leader, information referral specialist and observer of MS treatment evolution. None of the evidence suggests to me an improper treatment course. There is no cure, seldom is there even improvement and very often success of therapy is considered a stable or slow decline. Having MS is no picnic and treating one is not either. Treating MS is like leading the bull through the china shop, you can only try to get through it without causing too much damage.

  5. Submitted by Nancy Hokkanen on 12/09/2011 - 03:44 pm.

    FDA testimony on multiple sclerosis from mercury tooth fillings
    http://www.youtube.com/watch?v=9-qhxa-3Wbw

  6. Submitted by Rachel Kahler on 12/09/2011 - 04:23 pm.

    @#2
    *eyeroll* What a ridiculous charge. Profiteering off the illness of another through kickbacks from drug companies isn’t a progression of science. Thus, avoiding being an unconsenting guinea pig is not being a science denier.

  7. Submitted by Kate Kate on 01/17/2012 - 08:34 pm.

    Perhaps I can shed light on what is really going on.

    In regards to the clinical trials – Maran Watson, that’s how medical research works. A drug is created. It gets tested on animals. If it looks good enough for human trials, a small Phase 1 trial is done on a limited amount of patients. If all looks well and objectives are met, then it’s on to Phase 2 and 3. Phase 2 and Phase 3 studies are nation-wide, sometimes world-wide. If you want to test a new drug, you need a large population of subjects to prove its worth. The FDA needs this kind of evidence to show that it is effective and should be on the market.

    Pharmaceutical companies join up with a middle-man-esque corporation like PPD or PRA to ensure integrity and quality assurance all around is kept in place. PPD and PRA locate thousands of sites where the type of medical condition might be best found (a MS clinic if they’re looking at a new drug for MS, for instance). They approach that clinic’s research department and ask if they’d be interested in being a site for the clinical trial. The clinic may agree and after examining the study protocol (to determine if the rational of the study is reasonable – I know many doctors who refuse to do research trials they don’t think is fit enough for their patients), if the site thinks the study may benefit their patients in finding better medication for their patient’s needs, the clinic figures out how much it would cost them to carry out the study (like blood tests, MRIs, what their going rate is for physical examinations, etc). All study procedures would be reimbursed by the pharmaceutical company, because the site is not going to just do all these procedures that cost money for free. So yes, of COURSE any doctor participating in research would be reimbursed for costs accrued for study procedures.

    The doctor then identifies patients they believe may fit well for the study (a patient experiencing extreme fatigue may benefit from participating in a research study looking at a promising new drug for fatigue – especially if the patient has no insurance and couldn’t afford medication otherwise [any study patient gets treatment for free]) and approaches them to see if they’d like to be in the study.

    THIS IS HOW CLINICAL TRIALS GET PATIENTS. THIS IS HOW MEDICAL RESEARCH IS DONE. Nothing shady going on by your doctor. Clinical trials are also constantly monitored to make sure every detail is covered and the patient is getting the medical care that they should. Every doctor I’ve ever known that have been involved with clinical trials say the same thing to their patients – “I may be aligned with this research study, but my duty is to you the patient, first and foremost. The minute you or I feel like this study is not appropriate for you or puts you at health risk, I will pull you out of it.”

    In regards to the payments pharm companies give to doctors elsewhere, that is also a different picture in reality than what this article paints. Most docs are like lawyers in the way that they are convinced an hour of their time = $500-$1000. They will refuse to attend or listen to anything unless they are compensated for an hour of their precious time. They never agree to anything more than just showing up, but they do show up because it’s always more money than what they’d get for seeing patients for that same amount of time (a doctor may charge $800 per hour and only end up with $40 for it at the end). If by showing up they find that there’s actually basis for this drug being useful and they leave thinking that they may want to implement it, well, that happens. That’s how a lot of doctors find the best new drugs out there and get the best deals so they can provide it to their patients with low co-pay and free samples. But those samples? Gets worked into the amount “paid” by pharmaceutical companies to doctors. And those drugs can be expensive. Like $26,000-76,000 expensive.

    But most of the time doctors go to pharm events just to listen politely and leave with more dollars in their pocket than what insurance would pay them to see patients for that same amount of time. Pharm companies still pay doctors because it gets them in the door, but what they don’t seem to really realize is that most time the doctor isn’t there to be won over. They’re just there to show up and get paid. Maybe to help relations if the drug is actually very beneficial and they want to get it cheaper for their patients. But Docs are the biggest skeptics of them all when it comes to being showered with gifts and freebies by pharm companies. I typically hear doctors saying, “well, if they want to, they can, but it’s not going to buy my opinion. What will buy my opinion is whether or not the drug that they’re selling actually works well.”

    Doctors aren’t being bought with kickbacks like many people think. Don’t let the paranoia of this article get to you.

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