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DEBATE BETWEEN 2 NEUROLOGISTS: Do Physicians Rate the Risk of Disabling MS Less Than the Risk of Effective Treatment?

FOR NEUROLOGISTS: MS prescribing depends on balancing benefit against hard-to-assess risk. At the recent World Congress of Neurology in Vienna, two experts in MS debated whether physicians rate the risk of disabling MS less than the risk of effective treatment. The debate centered on how clinicians and patients perceive risk and how decision-making must be done collaboratively.

How much risk is appropriate in the treatment of multiple sclerosis? For that matter, which risks should we focus on: the risks of disabling disease or the risks associated with effective treatment? Balancing these risks falls on physicians and patients together, but do they see eye to eye?

At the World Congress of Neurology (WCN) last month in Vienna, Austria, two experts debated the question of “whether clinicians rate the risk of disabling MS less than the risk of effective treatment.” During the discussion, it also emerged that patients' concerns about the disease may differ somewhat from what clinicians see as most important.

The Pro argument: A firm “Maybe”

Christoph Heesen. Photo credit: Daniel M. Keller
Dr Christoph Heesen

While debates are usually “Pro/Con” or “Yes/No” affairs, Christoph Heesen, M.D., of the Institute of Neuroimmunology and Clinical MS Research at the University Medical Center Hamburg in Germany led off the discussion with a big “Maybe.” His opening slide showed a cartoon of a gaggle of smiling white-coated people standing by the bedside of a frowning man. The lead doctor was telling the patient, “When we want your opinion, we'll give it to you.”

Dr. Heesen said predicting disability is the “major hurdle we have in MS.” If that could be known, it would be so much easier to set a level of acceptable risk of treatment. As it is, he said, patients need to take a major role in deciding whether to take high-risk treatments.

Unfortunately, balanced evidence-based information to guide decision-making is often lacking. As an
example, searching PubMed for the phrase “natalizumab and risk perception” just a week before his talk yielded only three articles, one of which was his own (Heesen et al., 2010). One of the others was a position statement (Rudick, 2011) to facilitate patient decision making from the Mellon Center for Multiple Sclerosis at the Cleveland Clinic in Cleveland, Ohio. PubMed had nothing at all on alemtuzumab and risk perception.

Dr. Heesen asked what is an acceptable level of risk of progressive multifocal leukoencephalopathy (PML) with use of natalizumab, and who should decide? A 2009 survey showed that more than 80% of patients would accept a risk above 2 in 10,000. Fifty percent of physicians would have stopped natalizumab at that level. The real risk of PML was 4 in 10,000 then and is 33 in 10,000 now.

In a German study presented at WCN (PERCEPT, poster P247), both patients and physicians viewed MS as a fairly serious disease, but viewed the risk of PML as moderately low (about 8 to 11 points on a 25-point scale of “seriousness”). About one-third each of 681 patients and 90 neurologists said the patient should decide on the treatment after discussing it with the physician. About 58% of each group said they would like to decide together. A small percentage of patients and neurologists thought patients should decide themselves, the physician should make the decision after talking with the patient, or the doctor should decide alone.

The study also found that physicians' acceptance of risk has changed, with many willing to consider using natalizumab up to a 100/10,000 risk of PML. Dr. Heesen wondered whether physicians had gotten used to the risk or maybe were just following patients' desires.

Patients and physicians may also differ about what bodily functions are most relevant to the patient. Patients ranked walking, vision, and thinking and memory as high on their list of functions to preserve.

Table. Proportion of patients (N = 160) ranking each bodily function as first priority
Bodily function
MS <5 data-blogger-escaped-strong="" data-blogger-escaped-years="">
MS >15 years
Visual function
Thinking and memory

They ranked other bodily functions, such as hand power and coordination, skin sensations, lack of pain, bladder or bowel control, wakefulness and alertness, speech, swallowing, mood, and sexuality at about 10% or less.

In updated and revised results from the same study, “On the physician side it's walking, thinking, and hand functioning, and for the patient's side it's visual functioning, … thinking, and talking,” Dr. Heesen reported. “So there are differences, and these are the areas with the largest differences emerging.”

He concluded his presentation by saying that there are really two areas of diagnosis, one of the medical condition, and the other of patient treatment preference (Mulley et al., 2012). One scheme involves first “team talk,” then “option talk,” and finally “decision talk.”

In the team talk, the physician informs the patient of multiple treatment options and conveys that while the doctor is the medical expert, only the patient knows his or her own fears and desires. In the option talk, the physician lays out treatment options (including watchful waiting if appropriate) with their risks, benefits, and adverse effects. The physician observes the patient's reaction and continues the talk as long as the patient wants to learn more or the physician wants to learn more about what is important to the patient.

Finally, in the decision talk, the patient states a treatment preference when ready, consistent with his or her priorities, or asks the physician to make a recommendation. If the latter, the physician confirms what he/she believes to be the patient's priorities, offers a recommendation, and asks if it feels right for the patient.

The Con argument: “Not necessarily”

Daniel Ontaneda. Photo credit: Daniel M. Keller
Dr. Daniel Ontaneda 

Arguing that clinicians do not necessarily rate the risk of disabling MS less than the risk of effective treatment, Daniel Ontaneda, M.D., of the Cleveland Clinic’s Mellen Center for Multiple Sclerosis in Ohio explained that treatment is a delicate balance between benefits (e.g., maintenance of function, control of relapses and disease progression, and a sense of protection) and risks (e.g., adverse events, tolerability, decreased quality of life from medication, and a loss of independence from being on medication for life).

With the proliferation of treatment options over the past decade, medications now vary in their efficacy and especially their risks. At the same time, “our goal of treatment has changed significantly also in the last 5 years” from just suppressing clinical disease activity to controlling lesions evident on magnetic resonance imaging, Dr. Ontaneda said.

He, too, focused on patient priorities, the top one being how long it would take for the disease to progress, followed by the adverse effects of PML risk, liver failure, and leukemia, according to a study. “This attests to the fact that patients mostly are making decisions of treatment based on efficacy,” he pointed out.

Another study found that patient and physician perspectives were quite similar. However, they differed significantly on a few points. Patients valued mental health and limitations in their emotional role higher than did the physicians. Physicians rated physical limitations higher than did the patients.

In a survey of Danish general practitioners, physicians' willingness to recommend a drug depended on how the data were presented. A figure of relapse rate reduction was more persuasive than the number needed to treat or the annualized relapse rate reduction.

One problem is how to measure benefits and risks. Benefits are well established in the short term (e.g., relapses or Expanded Disability Status Scale progression within 3 to 6 months), are easily measured, and are predictable. Thus, they often form the basis for regulatory approval of drugs. Risks, on the other hand, especially risks of newer therapies, are not well established, are unpredictable, and severity is difficult to measure.

Without good evidence for the long-term benefits of many of the disease-modifying agents, it is difficult to truly assess risk. Still, these agents are often used to treat progressive forms of MS. “It's possible that the long-term effects of these medications aren't as good as we think they are,” Dr. Ontaneda said, so it appears that neurologists may have a “relatively high level of risk tolerance to significant side effects using therapies with marginal efficacy.”

Patient perceptions of acceptable risk appear to depend on their level of disability. As disability accrues over time, patients became more willing to accept more risk of treatment.

In conclusion, Dr. Ontaneda said that as with most diseases and treatments, MS therapy must be individualized. He advised at least four points for clinicians to keep in mind when balancing the risk of disabling MS against the risk of effective treatment:

  • Patient baseline criteria;
  • The patient’s risk-aversion profile;
  • Presenting the various treatment options; and
  • Making the decision with the patient and not for the patient.

“Basically, it's our job as neurologists to present options and to guide,” Dr. Ontaneda said.

After the formal presentations, he asked the audience how many people had actually treated PML associated with natalizumab. Two people raised their hands in an audience of roughly 300. He then asked how many had treated an MS relapse. “Almost all of us,” he observed, and furthermore, “Risk-benefit perception may be slightly different depending on what medication we study.”

Dr. Heesen added that a physician's perceptions of benefits and risks of treatment may also be affected by their clinical experience with patients with more severe disability or with a severe adverse effect such as PML. He agreed that therapy needs to be individualized and chosen in consultation with the patient.

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