Common melanoma procedure may not be effective or safe, medical journal warns

Friday, January 25, 2013 by: David Gutierrez, staff writer
Tags: melanoma, treatment, dangerous

(NaturalNews) A common, expensive and invasive melanoma procedure has never had its effectiveness or safety adequately proven, warns a special report published in the British Medical Journal (BMJ).

The procedure, known as sentinel node biopsy, is meant to detect the early spread of melanoma beyond the skin and into the rest of the body. It consists of taking a biopsy of the nearest lymph node to the melanoma. If cancer is found in the lymph node, doctors usually advise that nearby lymph nodes be surgically removed.

Sentinel node biopsy is now standard procedure following melanoma diagnosis in the United States and several other countries. It costs each patient between about $10,000 and $15,000. The total cost of all sentinel node biopsies in the United States in 2012 was more than $680 million.

Not for routine use

In 2006, a major trial on the safety and effectiveness of sentinel node biopsy known as MSLT-I was published in the New England Journal of Medicine. The researchers claimed that that patients who underwent sentinel node biopsy were significantly more likely to be free of the disease five years later than the patients who had not undergone the procedure, but did not find any evidence that the procedure was associated with an overall improved survival rate in that time.

The study's conclusions were controversial and in 2007, the National Cancer Institute, which funded the study, publicly said that the debate over the procedure remained unsettled. The researchers and journals have never published any correction or clarification of their findings. Although further analyses of the data were expected in 2008 and 2011, none have yet been published and there have been no explanations as to the reason for the delay. As part of the report, the BMJ contacted the lead researcher, but he would not give an estimated date for publication of these further results.

Critics have raised concerns that in the absence of evidence as to the procedure's effectiveness, patients are being needlessly exposed to lymph node surgeries with potentially severe complications such as severe limb swelling (lymphoedema), deep skin infection (cellulitis) and scarring. According to the BMJ report, as many of the 96 percent of all patients who undergo sentinel node biopsy will have such surgery.

In part due to such doubts, sentinel node biopsy has never been accepted for routine use in the United Kingdom. In fact, the National Institute for Health and Clinical Excellence (NICE) says that the procedure should only be performed as part of clinical trials carried out by centers with expertise. The report found; however, that at least 19 separate health facilities have performed the procedure since 2006, and that more than 1,100 sentinel node biopsies might have been performed in 2010-2011 alone. This is in spite of the fact that only two clinical trials of the procedure are ongoing in the United Kingdom.

According to BMJ Editor, Dr. Fiona Godlee, the report illuminates a larger problem within the healthcare system: relevant research goes unpublished, wasting money and placing patients' health at risk.

Sources:

http://www.sciencedaily.com/releases/2013/01/130108201647.htm
http://www.empr.com