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.

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.