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Study: UC San Diego Routinely Fails To Report Clinical Trial Results

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Study: UC San Diego Routinely Fails To Report Clinical Trial Results
Report: UC San Diego Routinely Fails To Report Clinical Trial Results GUEST: Charles Piller, West Coast editor, STAT

This is KPBS Midday Edition. On Maureen Cavanaugh. Was supposed to be a resource for -- the investigative report has found the cause of the noncompliance of the institutions like UC San Diego, the government website clinical trials.gov is not nearly as useful as it could be. Joining me to discuss why and what's at stake for patients is Charles Pillar, west coast editor, STAT . Does an online news publication that focuses on health and medicine including the science politics and business of life science. Charles, welcome to the program. Biggie so much for having me. Give written investigation into how well research institutions and drug company are comply with the law to disclose their clinical trial results. Why do we have such a long in the first place? It was long known that particularly drug companies were withholding important clinical trial information associated with their drugs for commercial reasons. In other words, maybe withholding some negative results. Or even postponing to release a positive result for competitive reasons. Before 2000 there was a Ms. underfoot to try to get some of that data more into the public domain. Some terrible experiences with drugs really harming a lot of patience when the results of clinical trials were not -- led lawmakers to try to get a more forceful law on the books. They did succeed in doing that. Starting in 2008 drug companies as well as anyone who conducts clinical trials, that means leading universities and nonprofits as well, have to provide results for many of their trials onto a government database that is called clinical trials.gov. And it's accessible to the playback -- public. Ballots doctors, patients and any interested parties including researchers understand more about research, what the results work and use that information to approve treatments and also to be able to map out new kinds of research that will be more effective in helping patients. Your article in STAT found that UC San Diego is among the biggest noncompliance. What were their numbers? UC San Diego is one of the most important clinical research organizations in the country. Its a university that is one of the top recipients of NIH funding. As a result we are naturally interested to see what UC San Diego's numbers would be. Out of the studies that we looked at, in 98% of cases, that is in 98% of the clinical trials for which UC San Diego was obligated by law to provide results to the clinical trial.gov database, they did not provide those results on time or at all. In other words, they slighted the law to this extreme degree more so than most other clinical research organizations in the entire country. We would say they are one of the worst offenders because in only 2% of their trials, did they follow the law and comply with it as written. Give us an idea of the kinds of drugs or treatments that UC San Diego is conducting these clinical trials on? They are doing a wide range of clinical studies. As one might expect with the gigantic medical Center. Everything from lung disease to diabetes research, hypertension research, many different types of cancer studies, anxiety disorders, spinal injuries. These are studies that go to the heart of what many of the most important health concerns are in our country. UC San Diego sent us a statement about their compliance with the clinical trials.gov. That statement reads in part, UC San Diego takes its reporting their responsibilities seriously. Its research results are published in journals, disseminated at national conferences, government website and through other means. We continue to strive to improve our processes and clinical trials.gov reporting is now exception. Their full statement will be on our website. So Charles, UC San Diego says it's recent -- and I know other institutions that you spoke with basically said our research results are published in journals. Isn't that good enough? That is a pretty common response. I am sort of in a way flabbergasted at the naïveté that that implied in that response. First of all, I think these folks know quite well that not all research is published. -- In medical journals. And not all research is announced at medical conferences. Many studies including smaller studies, studies with negative results that might be just as important to medical knowledge as the positive results, don't find their way into medical journals. Those journals also take off -- often years to adjust peer review and ultimately publish the findings that they do publish. Because of that combination of factors, the medical research within journals and within conferences is very much a partial record. What clinical trial.gov was trying to do and is still trying to do, is create a more comprehensive record. There is also to other really important advantages of having a public accessible and hopefully interactive and large database -- of these trials. What if because the data is required to be entered in a standardized way, it's must -- much easier to cross compare studies of the same drug or medical device. Than it is to sort through many different journal articles and different formats and different ways of parsing information. The second thing and I think this is quite important. Is that even though it's regarded as scientifically suspect, it is extremely common in academia and industry for researchers to ignore negative outcomes of their primary objective research and instead write up something they notice in the data that is regarded as secondary outcome. Why that is a problem is that the study is not designed to check out that secondary outcome exclusively. It can be scientifically misleading to rely on that as important finding in the study. So what you have a situation where a lot of published studies are focusing on what was really a secondary outcome. Let me give you an example that maybe some patients can identify with. Perhaps the drug is being studied for something like beneficial effect on depression. It's found that it has no beneficial effect. Perhaps no different effect than a placebo sugar pill might have on depression. But perhaps the researcher notices that in the patients who were in the clinical study that it had an effect on lowering blood pressure. They might say this is something we really want to publish and show that this is an effective drug for reducing blood pressure. That would be an example of a secondary effect. What I'm saying is that it's not something that was set out in the beginning of the study and can be scientifically proper or misleading to as the primary outcome. Where clinical trial.gov has a great advantage of that is it has an audit trail. What that means is that if a secondary outcome is being used as put forward as the primary issue in a study, it can be known by looking into the clinical trial.gov database. You can't get away with switching and cherry picking your results for commercial benefit. Arthur supposed to be consequences for not complying with the clinical trial law? Good point. There are -- the law in the books allows the national institutes of health to withhold funding from institutions such as UC San Diego for failing to comply with the law. That is for failing to provide results for the studies that are legally required to produce results. The FDA can fine drug companies up to $10,000 a day also for failing to provide those results. It turns out that neither of those government agencies have ever enforced a single pen penalty on a single entity. Is puzzling because some of the examples of flouting the law are so flagrant that it's just defies that they would not have been able to find -- and find a strong example of violating the law. They say the -- the agencies say that they are waiting for further rulemaking which they hope will be completed next year before they start to enforce penalties. But when they do, if they do I think you might see some better behavior on the part of these research institutions. Let me let everyone know that the article is called law ignored, patients at risk. It's on STAT news.com. I've been speaking with reporter Charles Piller. Thank you so much. Thank you.

A new investigation finds many research organizations, including UC San Diego, are violating a federal law that requires them to report clinical trial results.

The online news organization STAT published the report Sunday.

It shows that UC San Diego is among the "worst offenders" posting results late or not at all 98 percent of the time. The university is considered one of the top recipients of federal research dollars.

Under the law, the federal government can fine research institutions up to $10,000 per day for late reporting.

Charles Piller, West Coast editor for STAT, told KPBS Midday Edition on Thursday that UC San Diego “flouted the law to a really extreme degree.”

Piller said the purpose of sharing results of clinical trials is to improve research and treatment.

“Drug companies, as well as anyone conducting clinical trials, have to provide results for many of their trials into a government database,” Piller said. “That lets doctors, patients and researchers understand more about the research and use that information to improve treatments.”

UC San Diego School of Medicine issued the below statement in response to the STAT investigation. The university declined to have a representative on the Midday Edition show.

"Doctors and scientists at UC San Diego - and at institutions across the country - labor tirelessly to develop, conduct and publish research studies, all with the intent of delivering new and better drugs and treatments for patients. This work is complex, and is conducted in a complex regulatory environment with decreasing funding. UC San Diego takes its reporting responsibilities seriously. Its research results are published in journals, disseminated at national conferences, government websites and through other means. We continue to strive to improve our processes and clinicaltrials.gov reporting is no exception."