Introduction

The public seems to have developed an ever-increasing appetite for medical knowledge. Both print and social media, filled with stories about medical breakthroughs, reflects this demand. Some stories, such as those that could contain or cure a common yet devastating disease, get national exposure on network news. Last year, for example, an inhaled insulin treatment was touted as possibly being a cure for Alzheimer’s, although it had only been tested for four months on around 100 people.

One must wonder whether snippets of news like this give false hope to consumers or the research community without real knowledge about the trial. There have been concerns voiced in the scientific environment that when early results are shared, more background data should be shared, too.

Background

Great efforts have been made by regulators to assure that results from clinical trials are made public. The FDA requires that pharmaceutical companies report the findings of clinical trials within 12 months of their drugs being introduced into the market.

The global pharmaceutical industry has officially supported the need to publicize clinical trial results following the introduction of a drug into the market. Most companies have their own policies also available for public viewing.

The U.S. federal government established the public website, clinicaltrials.gov, to supply specific, factual information to the public regarding more than 100,000 clinical trials around the world. But even with this information readily available, is there enough transparency in drug development?

Issue

Should the FDA strengthen regulations to require that all results of early clinical trials be made available to the public?

Rule

More regulatory focus should be put on the reporting of early results in clinical trials if:

  • More extensive information would be beneficial to scientific research
  • More information could bring better understanding into the public arena regarding drug development

Analysis

Medical researchers have complained that not enough information is available from clinical trials. For example, a UC Davis School of Medicine researcher last year voiced concern regarding the lack of reporting on clinical trials for drugs that never make it to the marketplace. His concern was that important research findings, even though those findings do not lead to the development of a drug, should be available for overall scientific research. The results reveal efficacy and risk data. By not sharing the information, possible future breakthroughs would not be made, or the same mistakes or failures would occur. Other researchers echoed his concerns.

Also, earlier this year, a cross-referencing study published in BMJ revealed that only about 22% of clinical trials found listed in the Clinical Trials websites were compliant in publishing results within the required 12-month time frame. It also showed that the results of early trials (Phase II) were less likely to be reported at all. These findings show that important information is not being shared, and have led to a bill recently introduced in Congress calling for increased regulations. The bill asks for clinical trial results to be published in clinicaltrials.gov, even if the trial is discontinued, and that enforcement is enhanced.

Leaders in medical research and journalism agree that more information needs to be available to develop a better understanding of drug development. Unfortunately, juicy tidbits of possible breakthroughs are gobbled up by the media and often disseminated with drama and opinion. If more supporting research is shared in the public domain, health journalists and health education writers would have a better opportunity to write more balanced, and in-depth stories. And, if researchers are open with the media and take more time to explain results and what they mean, there is a better chance for consumers to read fair and accurate stories, which in turn would help them make better decisions about their own healthcare.

Conclusion

Medical research within the pharmaceutical industry continues to search for blockbuster drugs that will create huge profits as they meet medical needs. Over the years, regulators have strengthened regulations so that the pharmaceutical industry will make the results of its research available to the public. Still, too much research is going unreported, and too much hype and inadequate information remains available. The FDA needs to do its part to encourage the pharmaceutical industry to share its findings, no matter how insignificant or negative the results seem.

For more information on this issue, contact the Kulkarni Law Firm.