The Hoag Study was given the green light by the FDA in the summer of 2009, and the results are in, this study did not work…rather, let me clarify, this round of clinical studies did not work.
A company called Xoft (now owned by ICad), came up with a great idea, that once refined, could save women with breast cancer time and numerous trips to receive time-consuming and often painful radiation therapy. The device is the Axxent FlexiShield Mini and allows for a quick, high dose of radiation to be delivered to breast tissue that once surrounded the tumor. Immediately after removal of the tumor, the FlexiShied which is a kind of inflatable balloon is placed inside the cavity and a highly targeted dose of radiation is applied to the tissue. The heart, lungs and other vital organs are shielded from the harmful radiation. An entire course of radiation therapy can be administered in just one dose. The balloon shield however left behind hundreds of tiny particles of Tungsten (a heavy metal) in about 30 women who took part in the study.
Pure Tungsten has not been shown to be highly toxic if embedded inside the body. I found this page to be extremely informative about Tungsten and Tungsten compound poisoning.
In today’s NYTimes article about this, author Denise Grady quoted how ICad has offered to help the women affected by this study:
ICad has offered to pay for toxicology consultations for the exposed women, along with blood and urine tests to measure tungsten. The company has also said it will consider paying for mastectomies, and it commissioned a report to examine the scientific data on tungsten. The report said its toxicity appeared low, but that long-term studies were lacking.
The rest of the NY Times article focused on the fear and betrayal the study participants experienced which is totally understandable. It highlighted a few lawsuits that are now underway. I know the media loves to publish stories like this because they are awful to read. Like a pack of hungry dogs, our faith in clinical research and humanity is gnawed at when we read stories like this. But I’d like to offer a different perspective and one that supports and stands by clinical research regardless of the perils and tragedies that sometimes happen:
My heart goes out to the women who participated in this study. They are true cure heroes and have sacrificed their safety, well being and potentially the future of their own health for the advancement of science. Clinical research is a messy business, it is not guaranteed, the risks are many, and more harm can befall the clinical trial subjects than any good. However, clinical trials are the only way we have come up with to legally and as safely as possible move the edge of medicine forward. Clinical Research much like life is not a guaranteed affair but is certainly worth pursuing to our fullest abilities.
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