I have been closely following the sad saga of Daniel Hauser, the Minnesota teen who ran away with his mother rather than continue treatment for Hodgkin’s lymphoma. Fortunately, he and his mother have returned to Minnesota, hopefully to continue his treatment. There has been a lot of debate about the ethics of a court forcing his parents to allow him to undergo treatment, and unfortunately a lot of misinformation has been spread about the value of chemotherapy versus “alternative” treatments. I haven’t written anything about it since I have no expertise in chemotherapy, and Orac has done such an excellent job. However, one article from Bill Sardi at lewrockwell.com has dragged radiation therapy into the mix.
The case for not treating Daniel with chemotherapy is incredibly weak. The science is settled: with chemo he has a chance of cure that could be as high as 95%. Without treatment, he will, with all likelihood, die from cancer. So proponents of alternative therapies have had to resort to misleading statements about the efficacy of conventional therapy. For example, this ABC News article is headlined “Man Who Survived Without Chemo: ‘I’d Still Fight’.” It is a story about Billy Best, who ran away from home at the age of 16 to avoid receiving chemotherapy for his Hodgkin’s lymphoma. He is still alive today, and he attributes his survival to alternative treatments such as “roots, Indian rhubarb and slippery elm”. However, Best underwent at least two rounds of chemotherapy before running away. While not a full course, it still appears to have cured his lymphoma.
The article at lewrockwell.com engages in similar arguments; downplaying the efficacy of chemotherapy and radiation therapy. It also mentions a paper that appeared in the International Journal of Radiation Oncology, Biology, and Physics in February of this year. Mr. Sardi states in his article in regards to radiation therapy for Hodgkin’s lymphoma that the paper “shows major deficiencies in reports which substantiate this type of treatment.” In fact, the article does not show major deficiencies, but only inconsistencies in the way that these reports are published.
The paper by Drs. Bekelman and Yahalom from Sloan-Kettering is titled “Quality of Radiotherapy Reporting in Randomized Controlled Trials of Hodgkin’s Lymphoma and Non-Hodgkin’s Lymphoma: A Systematic Review.” They looked at 61 clinical trials on the effectiveness of radiation therapy in the treatment of lymphoma. What they found was that some of the published reports lacked data needed to accurately replicate the treatment in the clinic or in future research. They looked at six pieces of information needed to ensure consistency in patient treatment. These six measures were listed by the Radiation Therapy Oncology Group, a group that coordinates clinical trials across multiple institutions, to “ensure consistency and accuracy of treatment specifications and to minimize potential variations in the conduct of trials.” The six measures were target volume definition, radiation dose specification, fractionation specification, radiation prescription point specification, QA process, and QA process adherence.
A target volume is the anatomical site that needs to be treated. This can include the tumor, adjacent lymph nodes or other nearby tissue. For example, in treating prostate cancer sometimes we will include the seminal vesicles in the target volume since the cancer often will spread to them. We then design the treatment so that the target volume is irradiated to the prescribed dose. Obviously, the definition of the target volume can have large effects on the patient’s outcome. Too small a volume could lead to local failure, where the tumor is not completely killed and begins to regrow. Too large a volume will increase the amount of normal tissue that is irradiated and can cause unnecessary side effects.
In my first two posts explaining radiation therapy I talked about the issues surrounding how much dose to give and in how many fractions. I showed how changing the fractionation scheme can have dramatic effects on patient outcome. Therefore, the total dose and fractionation scheme used is critical information needed to reproduce the treatments from a clinical trial. The radiation point prescription indicates where in the body that the doctor prescribes the dose. Without getting too much into the details of treatment planning, the location of the point (or volume) of prescribed dose can raise or lower the total dose given to the target volume, and is therefore critical to applying results from clinical trials.
The final two measures refer to the quality assurance process needed to ensure that the dose is delivered as prescribed. Without testing, it is impossible to know whether the dose as specified by the trial protocol was actually delivered. This can include tests such as special measurements made by the medical physicist on test equipment to simulate an actual patient, measurements made on the treatment device to check output and performance, measurements of dose outside the patient to attempt to infer dose to the tumor and review of treated cases by a third party to check for errors. Without specification and proof of adherence to protocols, there is no way of knowing if the results are a valid test of those protocols.
The authors found that most of the reports studied had deficiencies in one or more areas. In particular, only seven of the reports (11%) documented adherence to a quality assurance process. However, the authors state that they did not have access to the original protocols and studied only the final report. Therefore, quality assurance was likely performed but not put into the final report. For clinical trials coordinated by the RTOG, for example, detailed quality assurance must be performed and audited by a third party in order to be accepted to the trial. Regardless, the point of the study was to evaluate the published reports, as these are all a clinical oncologist may have access to. It seems clear that groups which perform clinical trials need to improve reporting in order to assure the usefulness of their data.
Now that we know what the paper actually says, we can see that Mr. Sardi’s summary is misleading. Here is the entire paragraph from his article.
Ironically, the Hauser case comes just when radiation oncologists are questioning reports on the effectiveness of radiation treatment for Hodgkin’s lymphoma. A review of 61 trial reports that were published between 1998 and 2007, published in the February 1, 2009 issue of the Journal of Radiation Oncology Biology Physics, the official journal of the American Society for Radiation Oncology, shows major deficiencies in reports which substantiate this type of treatment. The question is, can cancer doctors assure with certainty that the treatment is science-based, something the new administration in Washington DC is pushing.
This is just incorrect. Nothing in this article says anything about the quality of the clinical data, only about the reporting of the protocols used. Without the including the recommended information, it is difficult to compare studies or apply them in the clinic. However, the results of the studies would still be valid if the studies are performed properly. The deficiencies are only in the protocol information included in the final published report, not in the trials themselves. If Mr. Sardi wants to attack the usefulness of radiation therapy for Hodgkin’s lymphoma, he will have to attack each of the many studies that have demonstrated a survival benefit. This paper does not make his argument for him.
I am sure that the debate over Daniel Hauser will continue, even if he gets the treatment he needs. There is a debate to be had over how much control the government should have over our health care. Personally, I think that if an adult wants to refuse treatment that is his or her right, but a child is not mature enough to make that decision. There is a gray area, though, if the treatment has only a small chance of success. How much painful treatment should a child have to go through if it is unlikely to improve the situation? This is an important question that I hope will be explored. However, that is not the question in this case. Daniel Hauser had a extremely good chance at survival before he ran off, and he hopefully still has a good chance. No matter what proponents of alternative medicine say, chemotherapy is the best treatment for Daniel and refusing it is child neglect.
BEKELMAN, J., & YAHALOM, J. (2009). Quality of Radiotherapy Reporting in Randomized Controlled Trials of Hodgkin’s Lymphoma and Non-Hodgkin’s Lymphoma: A Systematic Review International Journal of Radiation OncologyBiologyPhysics, 73 (2), 492-498 DOI: 10.1016/j.ijrobp.2008.04.058
