Buying Public Opinion: Conflict of Interest and Discussions about Drugs

Peer-reviewed publication of clinical trial results, expert opinions and patient advocacy groups are frequently used to support market approval of drugs and public policy discussions. A series of articles published last week raise serious questions about the conflict of interest issues in such information. Major aspects of public discussions involving new drugs may be tainted by funding by the manufacturers who tend to benefit the most from such dialogues. Publications about clinical trials have a higher likelihood to present positive outcomes of a given study if the study was funded by the industry. Investigators in industry-funded studies are frequently paid as consultants, paid speakers, honoraria and multiple other ways. According to the independent analysis, it seems that these investigators in turn help paint a positive light on the clinical trials in question by suggesting changes in study design, data analysis, and choosing data to be included in the publications. While it may appear concerning it hides the practical value of involving subject matter experts such as investigators in the design of clinical studies, and analysis of data. Such experts should help increasing the likelihood of trial success, which the report seems to confirm. Peer reviewed publications are good for scientific discussions but for regulatory approval, sponsors need to submit full reports of the study including all data and amendments to protocols. More importantly, all changes made to the study are submitted for regulatory review and IRB approval prior to implementation. These regulations assure that the regulators stay informed completely of the trial conduct and results to make accurate decisions. Additionally clinical trial financial disclosure requirements along with Sunshine act reporting of any payments made to the investigators assures that all relevant parties are made aware of the financial ties so they can check for any bias in the data. Conflict of interest in clinical trials is controlled in multiple ways but that does not stop companies from trying to influence public opinion about their products in other ways. A review of the public comments to CDC Opioid Prescription Guidance showed that most of the organizations opposing the guidance were funded by opioid manufactures and related companies.  Another survey of tweets by hematologists-oncologists found that doctors tweeted about drug products without disclosing their financial relationship with the companies whose products they were promoting. Another analysis found that more than two-thirds of patient advocacy groups are funded by companies. This raises serious concerns since in the recent years patient advocacy groups have played an increasingly influential role in regulatory decisions by FDA and new laws require FDA to put higher weight on patient opinion. However, companies have the right to involve future consumers of their products. All these reports raise important questions about the reliability of public data. As FDA develops guidance for using “Real World Evidence” in support of regulatory decisions, these concerns are sure to play a big role in the suggestions from the Agency.