Where is the outrage

I did a zoom presentation earlier this week for a big pharma company. Everyone I dealt with was delightful but after all was said and done, I wondered if perhaps they had extended an invitation to the wrong advocate.

That would be because it is no longer possible for me to remove my other hat, that of an activist.

Directly before my presentation a visual was shared that represented the conformed consent process and research biopsies. Subsequently I was asked how I advocate for myself.

I shared the story about my two most recent research biopsies, and how, after more than ten years in clinical trials, I had only just come to understand the difference between a research and a clinical biopsy. And that once I did understand, I was incensed. How at my last biopsy, I sat there in my johhnie on the operating table just prior to the procedure and essentially schooled the surgeon. Explained how I felt about a biopsy that was required of me in order to participate in a trial, but that would in no way benefit me. I used the word bullshit. And then I encouraged the surgeon to try to access some extra tissue, tissue that wouldn’t travel to a lab in Japan but would instead be reviewed at MGH in relation to my case.

For ASCO’s view on biopsies, have a read. But pay particular attention to these two paragraphs:

Another concern about participant risk centers on the informed consent process and whether potential participants are told of both the risks of biopsies and their lack of clinical benefit. Although many patients are willing to undergo research biopsies, they tend to underestimate the risks or express a willingness to assume a higher level of risk than clinicians and IRBs believe permissible. This could be seen as a willingness of competent adults to accept high levels of risk but could also reflect a lack of understanding of the risks in comparison with medical experts. In addition, participants may not understand the nonclinical nature of research biopsies or demonstrate a therapeutic misconception, where they mistakenly believe the biopsy will impart clinical benefit. Informed consent forms may not adequately describe the risks and the nonbeneficial nature of research biopsies in language that facilitates comprehension.

Additional concerns arise when research biopsies are a condition of trial enrollment and may impose a limitation on patient autonomy. This is particularly true for patients with refractory malignancies, who may feel they have no choice other than enrollment in a trial of an investigational agent. Ethical concerns regarding mandatory biopsies are reduced, however, if the trial is testing two standard-of-care treatments (eg, a comparative-effectiveness study with a translational component), because the treatment is available outside of the study. Finally, there are unanswered questions about participant burden related to research biopsies. Participation in trials imposes personal and financial burdens, such as lost time and travel-related expenses; research biopsies could be an added burden for some participants. For research biopsies to be ethically acceptable, these risks and burdens must be balanced by the potential benefits to society.

And yet the demand continues. I had two intrathoracic biopsies in my previous trial; refusing an optional third. Of course another biopsy was required for my current trial, but there was tissue remaining (possibly due to my request to the surgeon) from my previous biospy.

Anyway, let me try to frame this for you in such a way that it is a little bit more personal. What if you are at the drive thru at Starbucks and are charged for not just your coffee, but also for the order of the person in the car behind you. Not because you were feeling generous, ie: this was your own choice, but rather because it was mandated. ‘This overpayment will in no way benefit you, but will help the person in the car behind you” says the Starbucks employee. How does that make you feel?

Or, let’s say you are getting your hair cut and the stylist takes off an extra five inches. “Sorry,” they say. “This won’t benefit you in any way but it will go toward a wig for someone else.” When you ask who will profit from the sale of your hair, you are told it shall be the salon, not you. ‘But,” the stylist says, ‘Your hair shall help someone else.”

Maybe you are starting to get the idea. Only keep in mind that A. cancer patients are, by definition, a vulnerable population B. they enroll in trials not because they want to but rather because it represents an opportunity to stay alive (between a rock and a hard place) C. that most of them are generous people but giving away tissue samples is a bit of a stretch D. This is an invasive procedure, and not without personal risk.

And then there’s that–the risk. I have had numerous partial pneumothoraxes post biopsy, each requiring admission to the hospital. My insurance was billed for those hospital stays. I payed the copay. More generosity.

Plasma is one thing (I have had so much blood drawn over the past sixteen years) but tissue is another. To require me to literally donate a piece of myself simply for the sake of data that will ‘help others’ but not myself–well, it is an outrage. But until more people speak up, this outrage will continue.