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Reporting Back to Patients

Posted 2/15/2016

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  If you have been part of a clinical trial, you will find this upsetting. In spite of the 2007 federal law that mandated that all pharmaceutical companies, universities, and hospitals that conduct clinical trials must report all adverse effects and results on ClinicalTrials.gov, it turns out that this has not happened. Most companies and institutions seemingly have just plain ignored the rule.

  There are a number of possible reactions to this. One of the first, surely, is anger that these powerful players in Cancer World just ignore the law and seem to make their own rules. Another is worry, especially about the reporting of adverse events, for patients who have participated in trials. Wouldn't you want to know, if you were considering enrolling in a trial or if you have been part of one, that other people experienced cardiac events or liver damage or even just extreme nausea? Finally, I think that most of us are just plan curious about the findings of a trial that we participated in. As I have written about before, in 1993, when I was treated for my first breast cancer, I enrolled in a trial that scheduled concurrent radiation with the start of chemotherapy (after the planned six weeks of radiation, the chemo just continued); the question was whether chemotherapy would enhance the effect of radiation. I never saw or heard of any results, but I am guessing that it was not a positive answer, because the standard of care never changed to this schedule. 

  As I write this, I feel some mild (it has been a long time!) anger about never being informed about the results. After all, I, and many other women, allowed ourselves to be treated this way, and it was tough. I surely recall the physical impact (fatigue and burning) of this schedule.

  All of this is an introduction to an excellent essay by Susan Gubar about this situation. Here is the start and a link to read more:

Living With Cancer: A Broken Covenant With Patients
By Susan Gubar

As a cancer patient whose life has been miraculously extended by a clinical trial, I was shocked by
Charles Piller’s Dec. 13 essay “Law Ignored, Patients at Risk” in STAT News on lapses in reporting the
results of such trials. My first response was to ask: Is he a reputable journalist? Is the online venue in which
the article appears legit? When the answer to each of these questions came back a resounding yes, I began
worrying that cancer doctors and patients have been imperiled by irresponsible researchers.
In 2007, federal law mandated that all pharmaceutical companies, universities and hospitals
conducting clinical trials must disclose study results and adverse events on ClinicalTrials.gov, a website
used by a large percentage of doctors and patients. Mr. Piller’s evidence proves that pharmaceutical
companies have often failed to follow the law while prestigious medical research institutions have routinely
flouted it. Malfeasance appears to be the rule, not the exception.
An example from the pharmaceutical industry: According to Mr. Piller, in my home state, Indiana, the
nonprofit Hoosier Cancer Research Network, which runs trials for drug companies, terminated a study of
Avastin in 2009 because it did not help but harmed patients with metastatic breast cancer. During the next
two years, the trial’s investigators neither published their results in a journal nor posted them on
ClinicalTrials.gov. It was not until 2011 that the F.D.A. revoked approval of Avastin for metastatic breast
cancer because of its life-threatening risks. How many sick women were unnecessarily endangered between
2009 and 2011?

Read more: http://well.blogs.nytimes.com/2016/01/15/living-with-cancer-a-broken-covenant-with-patients/

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