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Chief Medical Editor Message

Evidence-Based Medicine vs. the Art of Dermatology

June 2008


Ihad the good fortune to attend a meeting at which pharmacy benefit managers were discussing dermatologic issues. While many of us dermatologists may swear epithets against those we consider managed care functionaries, their discussions of dermatologic issues were quite rational and patient-oriented. Some expressed pride in how high their plans were ranked and in how open their formularies were. They even described the mechanisms utilized in evaluating new drugs, uniformly including at least one dermatologist in any decision involving a dermatologic drug.

Derm’s Dearth of Evidence-Based Medications
One attendee, framing his comments with an apology to me, said that some of the medication prior-authorization requests they get from dermatologists lack any apparent evidenced-based foundation. Others echoed the comment, saying that, unlike cardiologists and other medical specialties, dermatologists’ coverage requests were “all over the map.” They often couldn’t make sense of why we dermatologists were requesting the medications we wanted for the patient.

Understanding the Complex “Art” of Dermatology
I wasn’t in the least offended by these comments. I take it as a badge of honor that we dermatologists do the best we can for patients despite not having randomized controlled clinical trials to guide every decision we have to make.
What we do is an art, a complex art. Psoriasis management provides us a great example of this. The extent and distribution of lesions vary; the characteristics of individual lesions vary; and the affected areas of the body differ in critical ways. Adding to the complexity of treatment decision-making is the availability of a host of different topical, phototherapy, and systemic treatment options from which to choose.

Understanding Derm Patients

As one of the pharmacy benefit managers noted, matching the appropriate treatment with the specific presentation of a skin disease probably involves considerably greater complexity than what beta blocker to use in the post-MI period. Adding to the complexity of our art is the fact that we are treating patients, not just lesions. Patients’ impressions of any given level of skin involvement are hard to predict. Patients also differ in their concern about side effects and in their acceptance of different topical preparations. These variations can be dramatic, if not maddening. Throw in patients’ various treatment compliance proclivities, some of which are quite bizarre, and pretty much all bets are off as to how any given patient will respond to any given treatment.

Evaluating the Evidence from Trials
And as bad as that is, at least for psoriasis we do have high-quality clinical trials for many treatments, albeit rarely any head-to-head trials of two active drugs. Even so, those studies involve the most bland and uniform patient populations; actual patients have various co-morbid conditions and medication histories that make the available evidence much less helpful. But that’s just the tip of the dermatologic iceberg. We care for patients with numerous other inflammatory diseases for which there may be no controlled clinical trials whatsoever.

Helping Decision-Makers Understand The Realities of our Specialty
So I understand when well-meaning pharmacists in managed-care organizations say that dermatologists’ requests often aren’t supported by “evidence.” I certainly understand when they say they don’t understand why we made certain decisions. What we do is often complex and artistic, not rote application of a defined protocol. It will continue to be that way for the foreseeable future. And that’s o.k. I enjoy the challenge of having to depend on one’s good judgment rather than simply following a protocol.

Steven R. Feldman, M.D., Ph.D.
Chief Medical Editor

 


Ihad the good fortune to attend a meeting at which pharmacy benefit managers were discussing dermatologic issues. While many of us dermatologists may swear epithets against those we consider managed care functionaries, their discussions of dermatologic issues were quite rational and patient-oriented. Some expressed pride in how high their plans were ranked and in how open their formularies were. They even described the mechanisms utilized in evaluating new drugs, uniformly including at least one dermatologist in any decision involving a dermatologic drug.

Derm’s Dearth of Evidence-Based Medications
One attendee, framing his comments with an apology to me, said that some of the medication prior-authorization requests they get from dermatologists lack any apparent evidenced-based foundation. Others echoed the comment, saying that, unlike cardiologists and other medical specialties, dermatologists’ coverage requests were “all over the map.” They often couldn’t make sense of why we dermatologists were requesting the medications we wanted for the patient.

Understanding the Complex “Art” of Dermatology
I wasn’t in the least offended by these comments. I take it as a badge of honor that we dermatologists do the best we can for patients despite not having randomized controlled clinical trials to guide every decision we have to make.
What we do is an art, a complex art. Psoriasis management provides us a great example of this. The extent and distribution of lesions vary; the characteristics of individual lesions vary; and the affected areas of the body differ in critical ways. Adding to the complexity of treatment decision-making is the availability of a host of different topical, phototherapy, and systemic treatment options from which to choose.

Understanding Derm Patients

As one of the pharmacy benefit managers noted, matching the appropriate treatment with the specific presentation of a skin disease probably involves considerably greater complexity than what beta blocker to use in the post-MI period. Adding to the complexity of our art is the fact that we are treating patients, not just lesions. Patients’ impressions of any given level of skin involvement are hard to predict. Patients also differ in their concern about side effects and in their acceptance of different topical preparations. These variations can be dramatic, if not maddening. Throw in patients’ various treatment compliance proclivities, some of which are quite bizarre, and pretty much all bets are off as to how any given patient will respond to any given treatment.

Evaluating the Evidence from Trials
And as bad as that is, at least for psoriasis we do have high-quality clinical trials for many treatments, albeit rarely any head-to-head trials of two active drugs. Even so, those studies involve the most bland and uniform patient populations; actual patients have various co-morbid conditions and medication histories that make the available evidence much less helpful. But that’s just the tip of the dermatologic iceberg. We care for patients with numerous other inflammatory diseases for which there may be no controlled clinical trials whatsoever.

Helping Decision-Makers Understand The Realities of our Specialty
So I understand when well-meaning pharmacists in managed-care organizations say that dermatologists’ requests often aren’t supported by “evidence.” I certainly understand when they say they don’t understand why we made certain decisions. What we do is often complex and artistic, not rote application of a defined protocol. It will continue to be that way for the foreseeable future. And that’s o.k. I enjoy the challenge of having to depend on one’s good judgment rather than simply following a protocol.

Steven R. Feldman, M.D., Ph.D.
Chief Medical Editor

 


Ihad the good fortune to attend a meeting at which pharmacy benefit managers were discussing dermatologic issues. While many of us dermatologists may swear epithets against those we consider managed care functionaries, their discussions of dermatologic issues were quite rational and patient-oriented. Some expressed pride in how high their plans were ranked and in how open their formularies were. They even described the mechanisms utilized in evaluating new drugs, uniformly including at least one dermatologist in any decision involving a dermatologic drug.

Derm’s Dearth of Evidence-Based Medications
One attendee, framing his comments with an apology to me, said that some of the medication prior-authorization requests they get from dermatologists lack any apparent evidenced-based foundation. Others echoed the comment, saying that, unlike cardiologists and other medical specialties, dermatologists’ coverage requests were “all over the map.” They often couldn’t make sense of why we dermatologists were requesting the medications we wanted for the patient.

Understanding the Complex “Art” of Dermatology
I wasn’t in the least offended by these comments. I take it as a badge of honor that we dermatologists do the best we can for patients despite not having randomized controlled clinical trials to guide every decision we have to make.
What we do is an art, a complex art. Psoriasis management provides us a great example of this. The extent and distribution of lesions vary; the characteristics of individual lesions vary; and the affected areas of the body differ in critical ways. Adding to the complexity of treatment decision-making is the availability of a host of different topical, phototherapy, and systemic treatment options from which to choose.

Understanding Derm Patients

As one of the pharmacy benefit managers noted, matching the appropriate treatment with the specific presentation of a skin disease probably involves considerably greater complexity than what beta blocker to use in the post-MI period. Adding to the complexity of our art is the fact that we are treating patients, not just lesions. Patients’ impressions of any given level of skin involvement are hard to predict. Patients also differ in their concern about side effects and in their acceptance of different topical preparations. These variations can be dramatic, if not maddening. Throw in patients’ various treatment compliance proclivities, some of which are quite bizarre, and pretty much all bets are off as to how any given patient will respond to any given treatment.

Evaluating the Evidence from Trials
And as bad as that is, at least for psoriasis we do have high-quality clinical trials for many treatments, albeit rarely any head-to-head trials of two active drugs. Even so, those studies involve the most bland and uniform patient populations; actual patients have various co-morbid conditions and medication histories that make the available evidence much less helpful. But that’s just the tip of the dermatologic iceberg. We care for patients with numerous other inflammatory diseases for which there may be no controlled clinical trials whatsoever.

Helping Decision-Makers Understand The Realities of our Specialty
So I understand when well-meaning pharmacists in managed-care organizations say that dermatologists’ requests often aren’t supported by “evidence.” I certainly understand when they say they don’t understand why we made certain decisions. What we do is often complex and artistic, not rote application of a defined protocol. It will continue to be that way for the foreseeable future. And that’s o.k. I enjoy the challenge of having to depend on one’s good judgment rather than simply following a protocol.

Steven R. Feldman, M.D., Ph.D.
Chief Medical Editor