Living With Cancer: A Broken Covenant With Patients
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?
An example from the prestigious medical research institutions: According to Mr. Piller, Memorial Sloan Kettering Cancer Center broke the law on 100 percent of its studies—“reporting results late or not at all.” In two trials of the experimental drug ganetespib, it failed to report adverse consequences — heart and liver disorders, bowel and colon obstructions, death — affecting “volunteers” with breast and colorectal cancers.
The word “volunteers” reminds us that the often debilitated participants in clinical cancer trials decide on their own accord to put their lives on the line, usually with no resulting personal health benefit. It also brings to my mind the first anxious days of my participation in the Phase I trial that I began in August 2012.
My husband and I undertook the one-hour drive from Bloomington to the Indianapolis cancer center at the crack of dawn. Inside a hospital room from 8 a.m. until 11 p.m., I spent a long period of that time fasting. Because the experimental drug had never been used on human beings before, I was monitored every hour with all sorts of tests that were followed by various infusions to offset potential side effects. Totally exhausted upon release, my husband and I got lost finding our way to a bleak motel, paid for by the trial because we had to return to the hospital the next morning for more testing.
The stressful and demanding start of the trial forecast its evolution. To date, I have had approximately 20 CT scans for the trial—not one of which was good for me physically or psychologically, but all of which help researchers ascertain how the drug I take works. Yet the knowledge they gain from this study remains barren, if it does not circulate among other researchers, cancer doctors, and patients. I benefit from the study drug, but no one else will be aided unless at its conclusion the results of the trial are promptly reported not just in a medical journal but on the site provided for the dissemination of information required by law.
Because of my own prejudices, I was dismayed but not surprised to read about the noncompliance of big pharma in Mr. Piller’s article. What I found appalling were the widespread legal and, to my mind, ethical violations of academics like me. Clearly university hospitals need to help faculty members disclose their trial results in a timely manner. Busy schedules, technical difficulties, or staff shortages should not be used to justify an egregious failure to report findings since widely circulated trial results — especially adverse or failed findings — insure the progress of research as well as the quality of treatment.
The scandal proliferates. Apparently the F.D.A. can levy fines up to $10,000 a day per trial for late reporting; however, it has never penalized any institution or company for failing to post on ClinicalTrials.gov. Why would such a revenue opportunity — that could be used to fund cancer research — be lost? And why has the N.I.H., which supplies so much federal funding for clinical studies but which has a spotty history of disclosure itself, not enforced the obligation to report?
Like quite a few patients, I live and breathe today because of cutting-edge research. With conventional medicine, I would have died back in 2013. So I remain fervent in my support of clinical trials. I am not alone among such supporters in believing that research investigators need to improve their accountability and transparency. Alltrials.net campaigns for all clinical trials to be registered and their result reported.
When before the start of my trial I read the 20 or 30 pages of boilerplate, I signed on the dotted line, even though the document informed me that the drug might kill me and that its administrators would not be held accountable. I signed because I wanted to see if a new approach might save me from the miseries of standard treatments that had proven inefficacious. I also signed because I wanted to help other people with cancer.
It was a legal and moral contract. Thousands of patients have kept our side of the covenant. The researchers and the institutions for which they work should keep theirs.
Susan Gubar is a distinguished emerita professor of English at Indiana University and the author of “Memoir of a Debulked Woman,” which explores her experience with ovarian cancer.
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