Physicians disclose their industry payments to one another, in meeting slides and at the very ends of papers, and that’s about as much transparency as exists in clinical trial operations. Many patients don’t know their doctor is often paid by the head for enrolling study subjects. While I think that doctors should disclose their financial relationships to patients, I also think the same standard should apply to any entity with patient contact.
Odonate Therapeutics is the latest company with rights to the oral taxane tesetaxel; the Daiichi drug was previously licensed to Genta, which of course went bankrupt in 2012. There are two publications on Pubmed showing the drug’s lack of efficacy in humans, specifically a phase I/II non-small cell study that reported a response rate of 5.6% and an all-solid-tumors study that reported a best overall response of stable disease in 82% of subjects when the drug was combined with capecitabine. Those papers were published in 2008 and 2011, respectively, and, combined with a graveyard of studies of unknown ClinicalTrials.gov status in melanoma, bladder cancer and gastric cancer, you’d think tesetaxel was finished.
Odonate sat on the drug for four years before going public in 2017 and announcing plans to conduct a 600-subject phase III trial in hormone-positive metastatic breast, CONTESSA. For ASCO this year, they helpfully stripped out their target CONTESSA population from data reported at ASCO 2012. That trial, which Genta sponsored, was called TOB203. The latest poster seems to exist entirely to promote CONTESSA, given that the only difference between them is that the 2018 poster is purple and the 2012 poster is blue. (Linked to the full-size posters because the pics are coming out small; and yeah, I’m sure that response rate in their previously-untreated, cherry-picked subgroup is going to hold in a phase III RCT.)
But ASCO isn’t Odonate’s only creative effort at marketing their trial. Because is it really over until you’ve preyed on the patients themselves? The first press release on the new Odonate website is dated October of 2017, where the company announced their financial support for the Susan G. Komen foundation. In case you were wondering, $1.5 million at Komen buys you a purple banner proclaiming you a “partner” at the bottom of the screencap for your emotionally-manipulative video.
This video is featured prominently at www.CONTESSAstudy.com, and given that Komen has previously licensed their pink ribbon to a bucket of fried chicken, this is not the most egregious offense. It gets worse. And no, I don’t think this is all on Odonate.
On June 1, this headline popped up at BreastCancer.org’s metastatic breast cancer forums, which are the most popular breast cancer forums online. There are over 20,000 posts, and this one is right at the top.
Per the site moderators:
Why, yes, that is an exclamation point. There are 650+ trials recruiting or about to open in metastatic breast cancer listed on ClinicalTrials.gov, and funnily enough, this is the only one that gets an exclamation point on the cancer boards. And what exactly are we so excited about?
Oh hell no. I replied to the post stating basically exactly that. I mean, this entire blog pretty much exists because oncologists are corrupt, but let’s just baseline here: if you talked up a trial like this to a patient, you’d lose your license. This is beyond irresponsible. It is effectively an endorsement of a clinical trial. (I found one other trial announcement on the board, for the NCI-funded E2112, and you can compare the treatment when you don’t pay up.) And check out the URL in the post: “Featured” Trial. It’s featured. Because they gave us money, but we’re not going to disclose that anywhere. CONTESSA is, at present, the only trial listed on the page linked in the post. BreastCancer.org are under no professional obligation to accurately represent the drug, and the obvious defense is that they don’t have the expertise to evaluate the available data, but isn’t that the point? You can’t buy that kind of promotion at a doctor’s office. You can only get it here.
And an exclamation point is certainly in order when discussing an investigational drug. That f*cking exclamation point.
Let me emphasize: I can’t fault Odonate for their “partnerships”. I kind of respect the imagination. They have one sad product that has been plagued by failed trials, a past clinical hold and several changes of ownership; since they have made the baffling choice to keep this thing alive (…why?), they’ve got no choice but to enroll a trial. So while tesetaxel may be doomed and reflect an embarrassing misunderstanding of the direction of oncology, the idea to fund patient groups in exchange for trial promotion may be the best idea anyone at Odonate has ever had. Not that it’s a high bar, but patients are scarce, this drug has disappointed, any onc has better business prospects and if a patient’s peers and advocates endorse it, well, that might be the only chance it has to enroll. I believe it’s absolutely morally wrong to waste patients on shit drugs, but the onus is on the entity that accepts the cash to behave ethically. You can always decline the money. Easy e-mail – We act in the best interests of the patients we represent.
But that e-mail didn’t go out, and the check cleared, so there you go. These people are bound to nothing; not honor, not patient outcomes, and they preach to metastatic patients with OS on the line. We demand our beauty bloggers disclose when they receive a free lipstick to review, but the moderators on cancer forums, who have the power to keep a post at the top of the very first page and influence decisions that are literally life and death, are not held to any standard?
This story has been kicking around for a month, because I wanted to give BreastCancer.org a chance to make it right. And to their credit, they made an effort. They changed the title of their trials page from “Featured Clinical Trials” to “Sponsored Clinical Trials.” (That f*cking exclamation point is still in the header of the forum post.) Whether my comment triggered it or not, and I hope I’m not the only person who objected, I’m happy about the change. I commented on the thread again to applaud them for their transparency, making sure to reference the old language, lest anyone who visits the page in the future forget that there was a time when BreastCancer.org thought they would get away with using “featured” as code for “paid advertising”. Give patients some credit. I suspect most of us understand that industry relationships are an essential part of drug development and don’t care – as long as people are honest about it. I don’t believe drug companies are out to get us, and my distrust is generally with the physician-middlemen who pretend (to patients, not their peers) industry doesn’t exist and doesn’t influence care. Of course it does. Let’s admit it and go forward, in service of true openness and collaboration.