The disease’s name refers to scars, or scleroses, that form in the brain and spinal cord over time.
On the day that he told me I had MS, my neurologist said I didn’t need to begin treatment immediately. But at my next appointment, he asked if I was interested in participating in a clinical drug trial he was conducting. I said I’d like to know more about it, and the study nurse showed me the trial’s consent form. The possible side effects were frightening, and I opted not to participate.
I have a background in medical ethics, so I was familiar with the potential conflicts of interest that exist for physicians participating in clinical pharmaceutical trials. I asked my neurologist if he was being compensated for running the trial, and he confirmed that he was. It was the kind of situation I would have advised students in my ethics courses to think deeply about.
But with my own health in question, my naturally skeptical faculties were silenced. I’d recently received a diagnosis of a serious chronic disease, and I wanted to be privy to any new studies or information that came my doctor’s way. At that moment, any worries about potential conflict of interest were trumped by a sense that I was lucky to have a neurologist on the front lines of MS research.
About six months later, during a routine appointment, my neurologist told me that new lesions had shown up on my most recent MRI. He thought it was time to go on disease-modifying treatment. (There is no cure for MS, so doctors usually describe medications as “modifying” the disease’s effects.)
Among the few options we discussed was Copaxone, the MS medication that’s supposed to have the fewest systemic side effects. This is a drug that MS patients self-inject either daily or every other day into the fatty layer just below the skin in the arms, thighs, hips or lower stomach. I agreed to start using it.
Life on Copaxone
But life on Copaxone wasn’t easy. Typically the medication doesn’t cause fatigue, nausea or depression, as some other MS drugs do. But no matter where I injected the drug each day, the injection site swelled up into a huge welt and felt like a gigantic bee sting.
About a week after starting Copaxone, I got a call from a nurse at an organization called Shared Solutions, wanting to know how my injections were going. My neurologist had asked if he could give my patient information to Shared Solutions, and I had agreed, assuming it had something to do with my health insurance. The nurse was extremely helpful, and I spent nearly an hour talking with her. Soon I began to receive letters and packages from Shared Solutions, including refrigerator magnets, a box for carrying Copaxone syringes on a plane and invitations to MS education dinners.
But the local side effects from the medication continued to worsen. Every time I injected Copaxone in my legs, I needed a cane just to move around my house. Why, I began to ask myself, was I taking a drug that was making me feel worse? It occurred to me there was no way to really know if the medication was helping. My next MRI might reveal fewer lesions, but this could happen even without medication.
Within a few weeks of interacting with Shared Solutions, I realized that the organization had nothing to do with my insurance. Some Internet research and a closer reading of the documentation I’d received revealed that Shared Solutions was a subsidiary of the pharmaceutical company that makes Copaxone.
It is common for patients like me, who are on costly specialty drugs, to be assisted by such companies. Some of these are subsidiaries of drug companies; others are divisions of health insurers or pharmacy benefit management firms.
One of their roles is to help patients stay on medication, even when they’re inclined to stop taking it because of side effects. There is evidence that staying on medication produces better outcomes for patients and yields cost savings compared, say, with the higher costs of being hospitalized for a severe flare-up of disease — even when drugs cost $25,000 to $45,000 a year, like those for MS. So I was thankful for the assistance of the Shared Solutions nurses, but I was also uneasy. It worried me that none of them 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.
I was never contacted by my neurologist, his nurse or anyone else in the neurology clinic with questions about how my Copaxone injections were going.
Maybe I’m old-fashioned, but I felt that the party who should have been helping was my neurology clinic, not a division of a pharmaceutical company. After about five months of taking Copaxone, and increasing numbers of welts on my body and increased difficulty walking after injections, I unilaterally decided to stop taking it.
At my next neurology appointment, one month after I stopped taking Copaxone, I told my doctor I’d stopped because of its side effects. He agreed that this made sense.
Less than a year later, my neurologist informed me that I’d begun to develop lesions inside my brain stem. This time he suggested a drug called Tysabri, which he said had worked wonders for some of his patients but also carried some risk.
I told him I’d think about it. As I researched Tysabri (having a background in chemistry was a help), I found that it originally was approved by the Food and Drug Administration in 2004. But the FDA had quickly put the drug on clinical hold after three patients taking it developed a condition called PML — progressive multifocal leukoencephalopathy — a debilitating brain disease that is often fatal. In 2006 the FDA allowed Tysabri to be reintroduced for use by some MS and Crohn’s disease patients under the condition that each patient taking it be enrolled in a strict monitoring program.
Even so, MS patients taking Tysabri are still dying from PML. According to an FDA safety update issued in April, for every 1,000 patients treated with Tysabri for 24 to 36 months, 1.5 are likely to develop PML. Since 2006, 102 people worldwide taking Tysabri have developed PML.
To me, this was a red flag. Now I had serious questions about where my neurologist’s loyalties lay — with the drug companies or with me? I needed more information.
Where I live, a state law mandates that payments any doctor receives from a drug company be reported to the Minnesota Board of Pharmacy, which enters it into a public database.
When I looked up my neurologist, what I found was damning. He had received more than $300,000 from drug companies between 2006 and 2008. (The 2009 data weren’t yet available.) Major contributors to this sum were Biogen, the manufacturer of Tysabri and the sponsor of the clinical trial my neurologist suggested to me early on, and Teva Pharmaceuticals, the manufacturer of Copaxone. In addition to many payments for acting as a speaker from these companies, my neurologist also had been compensated for “promotional/marketing consulting services.”
I knew that I had felt pressured by him to take medications. When I found that he had been paid six times my yearly salary to work for the manufacturers of those same drugs, my loss of faith was complete. I never returned to his clinic.
In fact, I have no idea whether my neurologist’s advice and judgment were affected by his relationships with the drug industry. But having MS is difficult enough. The last thing I needed was to worry about whether my neurologist was acting in my best interest.
Make it transparent
It’s understandably difficult for patients to trust physicians who have drug company relationships. Income that doctors derive from drug companies for “marketing consulting services” and “speaker fees” creates an unconscious social expectation of reciprocity, which, just as with any gift, has the potential to corrupt and distort any person’s advice.
Clinical trials serve an important goal of exploring new treatment options. These trials can’t take place without subjects, so I understand why there is a need to recruit patients. In an ideal world, however, clinical drug trials would be funded and administered by neutral, independent parties, eliminating ethical conflicts for physicians.
As a patient, I find it inexcusable that doctors aren’t routinely required to disclose their conflicts of interest to their patients.
I also believe that it should be made transparent to every patient — by his or her doctor — why any third party such as Shared Solutions is involved in his or her treatment. That should be especially true when the third party has a financial interest in the arrangement.
After months of searching for a new neurologist, one who didn’t accept drug industry money and whose services would be covered by my insurance plan, I finally found one I like. I trust his interpretation of my recent MRIs, and I took his advice when he said I should go back on an approved MS treatment. I’ve been able to fully commit to getting the care I need precisely because I have no reason to question my doctor’s loyalties.
During my first appointment with him, I asked him directly if he had any industry relationships; he told me he didn’t. At the end of our conversation, I asked if any other patients inquired about possible conflicts of interest. He shook his head no.
I was the only one.
Wolston is a doctoral candidate in philosophy at the University of Minnesota. This article is excerpted from the December issue of Health Affairs magazine and can be read in full at www.healthaffairs.org.