In my 2016 book about drug development, Nesiritide,1 I used the admonishment, “Never fall in love with a molecule,” as a chapter heading. A few weeks ago, the editors of Clinical Leader asked me to expand a bit on that aphorism. That explains why I’m sitting at my desk channeling my inner Ann Landers and writing an advice column for the pharmaceutical industry. To be entirely fair, the phrase is not originally from me. In 2005, I heard it from Randall Kaye, M.D., my first boss in the industry. But it made a real impact.
A busy practicing physician who might be asked by a friend or a patient for a first-impression opinion of the currently pending federal Right to Try legislation will find him/herself in a position roughly analogous to the hungry child being offered candy by a stranger: viscerally tempted, but intellectually very, very wary.
Boston Scientific deserves recognition for sponsoring the post-marketing PLATINUM Diversity study, a multicenter, open-label, single-arm, post-approval observational study focused on understudied populations: women, African-Americans, Latinos/Hispanics, American Indians, and Alaska Natives. PLATINUM Diversity enrolled 1,501 patients at 52 sites in the U.S.
The recent announcement that the watchdog group Center for Responsible Science (CRS) has filed a lawsuit against the FDA has raised some concerns in the clinical research community. The lawsuit is regarding the denial of the group’s citizen petition, which was originally submitted in June 2014.
Recently, a pharmaceutical executive raised an interesting question in the media. To paraphrase, he asked, “What should a corporate entity do when it has new information that is material to its financial situation and that new information is ‘under embargo’ until it is either published in a journal or presented at a scientific meeting?”