Is Pharma Truly Equipped For Transparency?
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
News from the past few months has clearly portrayed the ongoing struggle to establish and maintain transparency of how drugs perform in clinical trials. One of the most recent examples is a new lawsuit filed against Gilead by the Treatment Action Group and the Global Health Justice Partnership because of Gilead’s failure to grant access to the clinical trial data for the drugs Sovaldi and Harvoni. The two groups argue that should this data be revealed, physicians could gain greater insights into response rates to each treatment — especially the response rates in certain populations that experienced relapses or were not cured by the drugs. In being able to analyze this data, the two groups expect to determine the treatment gaps that exist for breakthrough hep C treatments as they become more widely prescribed, not only helping physicians make better decisions but also curbing rising healthcare costs in the long run.
As doctors continue prescribing these expensive hep C treatments to a wide variety of populations, the advocacy groups’ calls for data from the different population groups hint at a much broader definition of transparency. As is no surprise to anyone, those paying the high prices for the finished product are demanding to know just what resources went into a drug and whether that is being accurately represented by the price tag. But, as healthcare costs go sky-high, drugmakers are now also increasingly being called upon to provide more information about the value their drugs can bring to the market, including more evidence of a drug’s cost-effectiveness, comparative benefit, and real-world outcomes. However, as the call for transparency grows louder in the pharma industry, the question arises: are drugmakers equipped with all they need to be transparent — especially when it comes to demonstrating their drugs’ economic value?
Stats from a recent Avalere survey suggest the industry is still a long way off. A majority of respondents from pharma companies remain unclear about what kind of data they are able to share to truly demonstrate their treatments’ healthcare economic information (e.g. how the benefit and risk profiles of their drug compare to cheaper alternatives). As it stands, Forbes says, meta-analyses and uncontrolled observational studies, which can provide this necessary economic information, are not considered sufficient by the FDA to be included in a drug’s label. In turn, drugmakers are less likely to pursue these kinds of studies, choosing instead to focus resources on trials that only demonstrate a drug’s benefit in comparison to a placebo. As such, the industry is faced with a less competitive market and a shortage of information to help physicians and consumers make key decisions that could control healthcare costs.
There could be some answers for drugmakers on the horizon. Both The Affordable Care Act and the Patient Centered Outcomes Research Institute are looking to create new agendas, trial designs, and strategies to help encourage pharma companies to pursue and obtain the data necessary to compare treatment options and establish economic value. The pending 21st Century Cures Initiative is expected to address the lack of clarity over which types of evidence drugmakers are permitted to share. In particular, the industry is seeking more clarity on patient satisfaction and quality of life endpoints in economic studies — information that could be particularly valuable as drugs, like Gilead’s hep C treatments, continue to be widely prescribed in various population groups.
Perhaps as a step in the right direction, the FDA announced this week that it was teaming up with patient advocacy group PatientsLikeMe to get insights into patient data and to determine a drug’s risks and benefits over time. As PatientsLikeMe co-founder Ben Heywood said, this move was an “unprecedented step toward enhancing post-market surveillance and informing regulatory science.” This data, provided in real-time by patients themselves, will help give insights into tolerance, adherence, and quality of life and could perhaps one day be helpful in the establishment of drugs’ economic profiles.
However, until there is guidance published to help clarify current regulations, Forbes columnist Scott Gottlieb argues that current rules and regulations are “chilling” the free exchange of health economic information. Gottlieb even skates around the question of whether the current regulatory framework, which makes drugmakers cautious about sharing certain information, is actually hindering company free speech. I wouldn’t go so far as to make the claim that current regulations are completely freezing free speech, especially considering a study I found recently showing that some drugmakers have a few tricks up their sleeves when it comes to demonstrating their candidate’s value against a competitor.
The study, published in PLOS Medicine, revealed that roughly 75 percent of what’s being published in medical journals is industry-sponsored. Though the results in these articles are not the products of fraud, it seems some companies have a gift for asking the “right” questions to garner better results. For instance, a company might pit their drug up against too high or too low a dose of a competitor to establish a better safety and efficacy profile. A study such as this, as well as the recent Gilead lawsuit, serves to show that there are still many ways pharma needs to improve the methods with which it presents research- and clinical trial-related information. In fact, after reviewing the study, the question arises: if peer-reviewed medical journals can contain manipulated portrayals of a drug’s health value, is this the free-speech we should be aiming to protect?
However, it’s also becoming necessary to acknowledge that as the industry continues to evolve and healthcare costs stimulate concerns, transparency becomes an even broader term. Being transparent can no longer just be — and is not expected to be — releasing standard clinical trial information; the evolution of the market, industry competition, and the public’s/payers’ needs are requiring a shift as well in the information that pharma seeks out to measure the value of its meds. And, as the Avalere study suggests, pharma won’t be able to fully master transparency without a little bit of help along the way.