January 24th, 2018
The Lown conference is known for attracting experts who speak out boldly on issues that matter… and this year’s crop of speakers may be one of our best. So we’re conducting interviews with our keynotes as we lead up to the main event April 9-10 in Washington DC.
KEYNOTE INTERVIEW: Dr. Vinay K. Prasad, a hematologist-oncologist and Assistant Professor of Medicine at the Oregon Health and Sciences University. Prasad’s extensive research on medical reversal, industry bias in clinical trials, and drug pricing have shown the deep cracks in our privatized health care system. Prasad is the co-author of Ending Medical Reversal: Improving Outcomes, Saving Lives.
The Lown Institute: Your keynote at the Lown Conference is about what’s we’re doing wrong in biomedical research, how we can start doing it right. From what you’ve seen in your research, what fixes do we need in the clinical trial and drug approval process to improve drug safety and effectiveness?
Dr. Vinay Prasad: Although we are increasingly aware of the importance of reliable evidence, we have a regulatory system that is moving in the opposite direction. The bar for new drugs and devices continues to fall. Most of this is attributed to patient’s desire to have access to promising therapies, but I believe this narrative is incomplete. Patients are very different, and there is no one thing all want. Some are more risk inclined, and seek more options with greater uncertainty– this seems to be the only voice the FDA (Food and Drug Administration) is listening to.
But, from practicing in Oregon, I know there are many other patients who are not risk inclined. Patients who want more information. Who want good options, not just options. The current regulatory system doesn’t do justice to these patients. We have moved too far in one direction on the pendulum. In order to fix this, we have to limit the use of accelerated approval to the most appropriate situations, and strongly enforce post-marketing studies. There is a way to balance the interests of all patients in drug regulation, but the FDA has ignored the interests of patients who want more information.
Lown: Does it matter who conducts the clinical trials, as well as how they are conducted?
Prasad: We need to shift the clinical trial agenda from for-profit entities to non-conflicted parties. The NIH already funds research and manufactures some drugs – which they then sell to private drug companies who mark up the price. We could just take it another step forward and have a non-conflicted body design and conduct pivotal trials. Instead of going to the FDA with their study summary and $2 million user fee, companies would to the FDA with a $20 million trial fee, the compound, and the early trial data, and the FDA would design the pivotal trial.
Lown: You’ve written about the misinterpretation of research results in journals and the media. What changes can we make to reduce inaccurate information or “hype”?
Prasad: The media coverage of medical findings is often distorted. Not only is there bias in the choice of stories covered, but the coverage is relentlessly one-sided, focusing just on potential benefits and not real harms. There are a number of fixes to this problem, including better science education broadly, but one short-term solution for journalists would be always getting independent quotes from a skeptical scientist for each story covered.
Lown: What research projects are you currently working on or especially excited about?
Prasad: My clinical focus is cancer medicine. I’m involved in a number of projects, including taking a closer look at cancer screening, and examining how cancer drugs are used in practice. I am interested in whether the real-world benefits of cancer drugs are the same as in clinical trials, given the ocean of difference between carefully selected trial participants and actual Americans. We are doing a project on low-value practices, thanks to a grant from the Laura and John Arnold Foundation.