Negligent Drug Trial Reporting and Living with Cancer
By: Cohen, Placitella & Roth @ May 18, 2016
While we do not like to think about it, many patients who are currently living with cancer may have been harmed as a result of improper reporting of drug trial results. Indeed, according to a recent article in The New York Times, respected medical research institutions have routinely disobeyed the law when it comes to reporting the results of drug trials, and such practices put patients at risk. The article specifically discusses a recent essay published in STAT News “on lapses in reporting the results of [drug] trials.”
What do you need to know about this problem if you are currently living with cancer? And if someone you love underwent a drug trial for cancer treatment and suffered additional harms, how can you begin the process of seeking compensation?
Federal Law and Pharmaceutical Companies
As the article explains, a federal law that took effect in 2007 requires certain facilities to make known the outcomes of drug trials. Specifically, the law “mandated that all pharmaceutical companies, universities, and hospitals conducting clinical trials must disclose study results and adverse events on ClinicalTrials.gov.”
That website is one used by doctors and patients alike. However, despite the fact that a federal law requires certain disclosures about drug trials, the article emphasizes that even “prestigious medical research institutions have routinely flouted it.” To be sure, the article intimates that “malfeasance appears to be the rule, not the exception.”
Research Study Results and Adverse Events
While it is a serious problem that the results of drug trials are not being reported regardless of their outcome—whether the clinical trials simply have no effect or result in an adverse event—it is particularly troubling that the results of drug trials that end up harming patients are not being made public. In other words, when adverse events occur during clinical trials and cancer patients sustain injuries as a result of the drugs being tested, we need to know. But, according to the article, this kind of disclosure simply is not happening in every case.
For example, one clinical trial on Avastin, a cancer drug, conducted by the Hoosier Cancer Research Network stopped in 2009. Why did the researchers terminate the study of Avastin? The article contends that it harmed patients currently suffering from metastatic breast cancer instead of helping them. In short, adverse events occurred during the drug trial. Yet despite the fact that adverse events took place, “the trial’s investigators neither published their results in a journal nor posted them on ClinicalTrials.gov.” Two years later in 2011, the FDA “revoked its approval of Avastin for metastatic breast cancer because of its life-threatening risks.”
While the drug is no longer on the market, hundreds of women (and perhaps even more) could have sustained preventable injuries from using Avastin before the FDA recognized its harms. But if the researchers had properly published results of the clinical trial, those women may have been able to avoid life-threatening injuries associated with use of Avastin.
Contact a Medical Malpractice Lawyer in Philadelphia
The legality of drug trials and patients’ informed consent are complicated matters. If you or someone you love experienced an adverse event after participating in a clinical trial, you may be able to file a claim for compensation. You should contact an experienced Philadelphia medical malpractice lawyer as soon as possible. Contact Cohen, Placitella, & Roth, PC to learn more about how we can help.