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Letter to the Editor

Regarding "Recommendations for Zoledronic Acid Treatment of Patients with Bone Metastases"

The Lung Cancer Online Foundation, East Setauket, New York, USA

Correspondence: Karen Parles, MLS, Lungcanceronline.org, The Lung Cancer Online Foundation, East Setauket, New York, 11733; e-mail: kparles{at}lungcanceronline.org

As a cancer patient and advocate who has been receiving zoledronic acid for bone metastases since August 2002, I read Dr. James R. Berenson’s recent article, "Recommendations for Zoledronic Acid Treatment of Patients with Bone Metastases," in The Oncologist [1] with concern regarding its failure to mention the association of osteonecrosis of the jaw (ONJ) with intravenous bisphosphonates. Since September 2003 when Marx first reported a 36-case series in the Journal of Oral and Maxillofacial Surgery [2], there has been an increasing number of published articles and research investigations into this serious condition found in some patients receiving intravenous bisphosphonates engendering awareness, debate, and study of the ONJ issue in the multiple myeloma medical and advocacy communities. Patient safety concerns prompted a post-marketing addition to the FDA-approved label for Zometa (zoledronic acid) Injection in August 2004 [3], and a related "Dear Doctor" letter from Novartis in September 2004 [4], that specifically warned of cases of osteonecrosis of the jaw in patients receiving bisphosphonates, most commonly in association with a dental procedure. Given the immediate implications for patient care and the stated CME objective of educating readers regarding "the types of adverse events associated with intravenous bisphosphonate therapy," it is difficult to imagine how this potentially devastating complication was left out of Dr. Berenson’s article. Unfortunately, given Dr. Berenson’s financial relationships with Novartis (per disclosure, Dr. Berenson is a member of Novartis advisory board and a recipient of grants and honoraria from Novartis), the appearance of conflict of interest raises itself.

The challenging issue of commercial bias in CME content is a timely one with a recent "perspective" piece by Robert Steinbrook, M.D., in the February 10, 2005, issue of the New England Journal of Medicine that discusses the updated ACCME standards for CME commercial conflicts-of-interest [5, 6]. In seeking to provide unbiased CME content, I question the choice of a sole author, such as Dr. Berenson, who has financial ties to the manufacturer of the commercial product he is reviewing. Furthermore, the financial relationships of the members of the Monterey Zoledronic Acid Advisory Board (whom Dr. Berenson thanks for their "insight and input") but who are not co-authors, and the Institute for Myeloma and Bone Cancer Research, of which Dr. Berenson is CEO and President, are not disclosed. Thus, a reader is left without information to mitigate conflict of interest as a possible explanation for Dr. Berenson’s omission of critical information from his CME review.

Interestingly enough, the ONJ-bisphosphonate association was discussed in an article on the safety of intravenous and oral bisphosphonates published in the September 2004 supplement to The Oncologist. In my opinion, the absence of any information on the ONJ issue in Dr. Berenson’s review of zoledronic acid published in January 2005 points out a serious editorial inadequacy.

I hope Dr. Berenson and the editors of The Oncologist will update The Oncologst’s CME exercise to include pertinent information that allows patients to take steps to reduce their risk of a potentially horrific complication of bisphosphonate therapy. It is heartening to see that The Oncologist has suspended CME activity and provided links to relevant information for its online readers. However, it is important that the author and editors take time to consider why a patient advocate, and someone potentially at-risk for bisphosphonate-related ONJ, finds the occurrence of this error of omission distressing and unacceptable—and why they should, too.

	DISCLOSURE OF POTENTIAL CONFLICTS OF INTEREST

Top Disclosure of Potential... References

 
The author indicated no potential conflicts of interest.

Editor’s Note: Dr. Berenson’s article was not solicited, but rather was a proffered paper. Please see Dr. Chabner’s editorial response on page 301.

	REFERENCES

Top Disclosure of Potential... References

 

1. Berenson J. Recommendations for zoledronic acid treatment of patients with bone metastases. The Oncologist 2005;10:52–62.[Abstract/Free Full Text]
2. Marx RE. Pamidronate (Aredia) and zoledronate (Zometa) induced avascular necrosis of the jaws: a growing epidemic. J Oral Maxillofac Surg 2003;61:1115–1117.[CrossRef][Medline]
3. Zometa (zoledronic acid) Injection: Prescribing Information (Rev: August 2004):20. Available at: http://www.pharma.us.novartis.com/product/pi/pdf/Zometa.pdf
4. Novartis "Dear Doctor" letter: September 24, 2004. Available at: http://www.fda.gov/medwatch/SAFETY/2004/ZometaHCP.pdf
5. Steinbrook R. Commercial Support and Continuing Medical Education. N Engl J Med 2005; 352:534–535.[Free Full Text]
6. ACCME Standards for Commercial Support (September 2004). Available at: http://www.accme.org/dir_docs/doc_upload/68b2902a-fb73-44d1-8725-80a1504e520c_uploaddocument.pdf

Related articles in The Oncologist:

Late Toxicities of Drugs: Bisphosphonates

Bruce A. Chabner
The Oncologist 2005 10: 301-303. [Full Text]  

This article has been cited by other articles:

				B. A. Chabner Late Toxicities of Drugs: Bisphosphonates Oncologist, May 1, 2005; 10(5): 301 - 303. [Full Text] [PDF]

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