Many adverse side effects and even deaths are occurring due to medical negligence. Specifically, this is due to the irresponsibility of scientists who are not reporting the results of their clinical trials to the public, as required by a 2007 law.
According to a study published in the New England Journal of Medicine, the public access website clinicaltrials.gov draws 57,000 visitors a day, including people who are confronting serious diseases and seeking help to treat them with experimental drugs.
The study from Duke University found that five years after the reporting law took effect, only 13% of scientists running clinical trials are divulging their results.
Dr. Monique Anderson, a cardiologist and the study’s first author, thinks it is quite surprising that very few people are following the law.
Though there are exceptions to the law that would allow some results to temporarily pass on publishing results, Dr. Anderson feels that scientists should feel ethical tug to publish what they find. She believes it is their obligation to provide the public data, which is most often generated by human volunteers. She explains:
“Any patient who participates in clinical research should expect to see that their participation is going to be used effectively.”
Without publishing the data, people who are seeking treatments and solutions are being shortchanged. This also means that adverse effects from hopeful treatments are not disclosed, which can put the public in danger.
In one specific case, Larry Lightner began searching clinicaltrials.gov when his 9-year-old son, Glenn, developed a rare brain cancer.
In early treatment, Lightner’s son underwent radiation treatments that at first seemed to be effective, but soon thereafter, Glenn developed some serious side effects from his cancer treatment. He developed a second cancer which was much worse than the first. It was such an aggressive form that oncologists at NYU suggested Lightner look into clinical trials because they had no other treatment options available.
A Brick Wall: ‘No Results Posted’
Lightner isn’t a scientist, but he scoured clinicaltrials.gov every night for four years looking for a cure for his son’s cancer. He wanted to stumble on anything that could hel. He explains:
“Every time I clicked on the results tab, it always said ‘no results posted,’ night after night, year after year.”
Sadly, Lightner was looking through less than 13% of actual results, since many, according to the Duke study, weren’t included due to lawful exemptions. It was also impossible to determine if scientists simply neglected to report their results or simply didn’t have to.
What’s more, it was impossible to determine if experiments sponsored by the pharmaceutical industry had a much better track record than university experiments funded by the National Institutes of Health or other agencies.
Furthermore, about half of the missing reports from industry-sponsored research were temporarily exempt. Companies were allowed to sit on their data (and still are) to keep a competitive advantage if they’re trying to develop a new drug.
In Cases of the NIH, Many Reports are Just Lagging.
Even including the late entries and allowable exceptions, only about 50% of taxpayer-funded research has been reported back to the taxpayers on clincicaltrials.gov.
Duke University is considered one of the few good examples of what a university needs to do to comply with the law.
“It was extremely difficult,” says Dr. Mike Stacy, a neurologist and vice dean for clinical research at Duke. Stacy explains that the university had a team working for months to develop a compliance system, including keeping two full-time staffers to unravel the complicated rules and to remind Duke scientists to fill out the required forms. Stacy added that it can be difficult to get scientists to comply when they are already very busy people caught up in their workflow.
This is arguably (maybe) forgivable, but what about the scientists that simply don’t want to publish negative outcomes on clinical trials?
Some Researchers Avoid Publishing Bad News
The concern is that the scientists who aren’t complying with the publishing laws aren’t simply busy. Scientists are much more likely to publish good news and push bad news to the back burner, which then skews the scientific record.
What’s more, it was revealed that what’s published in medical journals doesn’t necessarily match what was reported on clinicaltrials.gov.
In many cases, results were reported in more detail on clinicaltrials.gov than in their corresponding journals. Even some serious side-effects are often left out of the public record. This can make it difficult for citizens to discern the true efficacy of a pharmaceutical drug or trial treatment.
Even though universities who don’t report their studies on time can face fines of $10,000 a day, or even lose their research grants, nobody is really being held accountable right now.
Lightner, in memory of his son who passed from his aggressive brain cancer at age 14, is rallying patient-advocates to support disclosure rules with no exceptions. He has a well-visited Facebook page and a website, FixCancerNow.
“There are a lot of parents who have asked for the results of a clinical trial that their child was in, and they will not get an answer,” The scientists “refuse to give them the results.”