Clinical Briefs: Big PharmaSounding the Alarm(a)
With Comments from Russell H. Greenfield, MD. Dr. Greenfield is Medical Director, Carolinas Integrative Health, Carolinas HealthCare System, Charlotte, NC, and Clinical Assistant Professor, School of Medicine, University of North Carolina, Chapel Hill, NC.
Source: Topol EJ. Nesiritidenot verified. N Engl J Med 2005;353:113-116.
Goal: A call to action.
Study Design: Editorial.
Methods: The author reviews the data surrounding the approval process for and the use of the agent nesiritide, or recombinant human brain natriuretic peptide, for the treatment of congestive heart failure (CHF), as well as the aggressive marketing campaign launched by its manufacturer (the latter of which includes information provided to physicians to develop their own infusion centers, through which Medicare can be billed similar to provision of chemotherapy, as well as a toll-free telephone hotline for "Natrecor Reimbursement Support").
Conclusion: "We need to tune-up our procedures to eliminate indiscriminate use of drugs, such as nesiritide, when there is not proper evidence of safety."
Quotations of note: "How can a drug that is associated with higher rates of both renal dysfunction and death than placeboand that costs 50 times as much as standard therapies and for which there are no meaningful data on relevant clinical endpointsbe given to more than 600,000 patients and be promoted throughout the United States for serial outpatient use, an indication not listed on the label?"
"We practice medicine in an era in which there is one pharmaceutical-company representative for every five physicians and in which companies will stretch the limits in their marketing of drugs."
Who knew?: A single small, open-label feasibility study in support of the use of nesiritide has been published, yet outpatient use of the agent for people with CHF is becoming commonplace; nesiritide has no proven clinical advantage over less expensive therapy for CHF (such as nitroglycerin) with respect to hospitalization or survival rates; data exist showing that nesiritide has an adverse effect on 30-day mortality rates, as well as an association with longer hospital stays.
Comments: Never before has Alternative Medicine Alert chosen to focus attention on an editorial, but this piece stands out for its candor, the credibility of the author and his credentials, and the journal in which it was published. In this age of The Constant Gardener and industry scandal, this call to action emanates not from a fringe radical periodical, but from a respected contributor to conventional practice in the pages of one of the most prestigious of conventional medical journals. Yet, the article was not chosen for review solely to point out problems with Big Pharma, lest we turn a blind eye to major problems in the vitamin and supplement industry. No, the article was chosen in support of the plea that the same microscope be applied to all potentially therapeutic interventions, be they deemed conventional in nature, alternative, or complementary. The oft-stated goal of "open-minded skepticism" applies equally well to all realms: Demand evidence of safety proportionate to the degree of risk involved to the patient, in addition to evidence for or theoretical construct supporting clinical efficacy, prior to employing any intervention. When data exist pointing to significant consequences associated with an intervention, that intervention should be withheld, regardless of which "camp" we sit in.
What to do with this article: Make copies to hand out to your peers. [Thanks to Randy Horwitz, MD, PhD, for bringing this article to our attention.]
Greenfield RH. Big Pharma--Sounding the alarm(a). Altern Med Alert 2005;8(10):119.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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