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Orange Alert for Oncologists

Received July 13, 2007; accepted for publication July 13, 2007.

Coping with terrorism and its consequences has become a part of our daily life, particularly for those of us with family or friends affected by 9/11, for those in the military, and for those of us who travel a lot, but it has only rarely affected our work as physicians and clinical researchers. The assassination of physicians in abortion clinics was perhaps our first close encounter with fundamentalist ideologues. Recently, the same misguided violence has been directed at members of our subspecialty who have chosen the threat of violence as their means of protest over the professional negative opinions about a vaccine for prostate cancer.

As recounted in recent stories in the lay press [1], the Provenge® (Dendreon Corporation, Seattle, WA) vaccine for treatment of prostate cancer was recommended for marketing approval by a vaccine advisory group, a nononcologic committee, at the U.S. Food and Drug Administration (FDA), despite the vaccine's failure to achieve a positive response endpoint in its pivotal phase III trial. The FDA has not accepted that recommendation, and for good reason.

Howard Scher, a well-known and highly respected prostate cancer specialist from Memorial Sloan-Kettering Cancer Center and many others in the prostate cancer field publicly expressed their opinion that the data did not justify marketing approval. For that, Scher and others were subjected to blistering attacks on the web and in public statements from so-called "advocates," who want early access to whatever they think "might work." Their argument is that, for patients who face the threat of death due to cancer, restrictions on their options are unreasonable. Their reaction degenerated into threats of personal violence and death against Scher and his colleagues [2]. This episode has provoked an outcry from prominent members of the cancer field, including many who have been thoughtful advocates for a speedier process of drug approval, but see these new tactics as abhorrent.

This sort of oncoterrorism, if successful in intimidating opposition within the ranks of government and research, would spell the end of science as the basis for FDA decision making. As a prostate cancer survivor and physician, I can state without reservation that these "advocate terrorists" do not speak for me or my patients. I do not take this as a joke or hyperbole. I take it as a fundamentally flawed notion that scientific data are no longer the basis upon which the FDA should make its decisions. I trust the FDA. It may be conservative at times, but the Agency's decisions in the oncology field are consistent with scientific thinking and respectful of evidence-based data [3]. Ideology and wishful thinking have no place in the approval process. Advocacy should focus on supporting science and scientific progress, not on steamrolling those who do not share an opinion or ideology. Protest and disagreement are acceptable, but terrorism is not.

I am personally in total support of making available promising new therapies prior to approval, if that decision is based on supportive evidence from clinical trials. There exists a process for obtaining drugs for compassionate use, but it is underused by industry for a variety of reasons, and is certainly no substitute for approval and marketing. Making experimental treatments available in the absence of significant evidence of efficacy, makes little sense to most oncologists, and has the potential to do great damage to the clinical trials process. We all will suffer the consequences.

The world was shocked to discover that physicians were embedded in the attempted bombings in Britain this summer [4]. The threats by patient advocates to medical researchers in the U.S. are no less alarming. Both should be condemned.

Terrorism has no place in a society committed to the rule of law and reason.
We all, physicians and laypersons alike, should forswear: Primum non nocere, "Above all, do no harm!" [5].

Bruce A. Chabner, M.D., Editor-in-Chief

	REFERENCES

Top References

 

1. Pollack A. Panel Endorses New Anti-Tumor Treatment. The New York Times. 2007, 3, 30, Available at http://www.nytimes.com/2007/03/30/health/30vaccine.html?ex=1184472000&en=23433f5ef1edd819&ei=5070.
2. Stein R. FDA Delay In Cancer Therapy Is Attacked. The Washington Post. 2007, 7, 6, Available at http://www.washingtonpost.com/wp-dyn/content/article/2007/07/05/AR2007070502149.html. Accessed July 24, 2007.
3. Chabner BA, Roberts TG. The FDA in 2006: Reasons for optimism. The Oncologist 2007;12:247–249; doi:10.1634/theoncologist.12-3-247.[Free Full Text]
4. ‘Terror Ringleader’ Is Brilliant NHS Doctor. Daily Mail. 2007, 7, 2, Available at http://www.dailymail.co.uk/pages/live/articles/news/news.html?in_article_id=465481&in_page_id=1770&ct=5. Accessed July 24, 2007.
5. Smith CM. Origin and Uses of Primum Non Nocere — Above All, Do No Harm! J Clin Pharmacol. 2005, 45, 371, 377, Available at http://jcp.sagepub.com/cgi/content/abstract/45/4/371. Accessed July 24, 2007.[Abstract/Free Full Text]

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