Tag Archives: medical research

That dog, those boots, these lungs

Kumo and I just returned from our second walk today, during which I was taking my customary long strides and deep, deep breaths.

Two weeks ago this was not possible. My fitness had declined to the point that it was, frankly, becoming more difficult to move around.

My lungs have been through a hell of a lot. Not once, not twice—again and again over a period of sixteen plus years. And yet, given the opportunity, they are still capable of a good deal of bounce back. This is something I do not take for granted.

Three weeks ago I would have said that it was unlikely I’d be here for next Christmas. Now I am back to measuring time in years versus months.

Isn’t medical research a remarkable thing.


Henrietta Lacks and her legacy

The Senate has passed a Henrietta Lacks Bill.

Henrietta Lack’s story is a cautionary tale and this bill is an attempt to right an eternal wrong (the cell line derived from Henrietta’s tumor is immortal).

However, I can’t help but feel that this is not only too little too late, it is disingenuous as well. Take line seven and eight from the bill:

(8) For more than 20 years, the advances made possible by Henrietta Lacks’ cells were without her or her family’s consent, and the revenues they generated were not known to or shared with her family.

(9) Henrietta Lacks and her family’s experience is fundamental to modern and future bioethics policies and informed consent laws that benefit patients nationwide by building patient trust; promoting ethical research that benefits all individuals, including traditionally underrepresented populations; and protecting research participants.

So what has changed in the 70 years since tissue was taken from the tumor of Henrietta Lack’s without her knowledge? This. Now we must give informed consent. However, how informed is that consent? As I quoted an article from ASCO in a previous post:  ‘Informed consent forms may not adequately describe the risks and the nonbeneficial nature of research biopsies in language that facilitates comprehension.

There have been efforts to make reparations to the Lacks family–in October a six figure donation was made to The Henrietta Lacks Foundation by the Howard Hughes Medical Institute. But I can assure you that those of us participating in medical research now do not share in any of the profit and to suggest otherwise is erroneous. Should we be injured as a result of a clinical trial, there are no reparations–our insurance will be billed. If we are lucky, then some of our additional expenses are repaid. In my own case, I have yet to be compensated for anything. Certainly not co-pays. Not even my parking.

I am not in the position, as a white woman, to even begin to address the part of Henrietta’s story that has to do with race. All I can do is to acknowledge it. Henrietta’s story, like the Tuskegee Syphilis Study, took place such a very short time ago. And faith takes a very long time to rebuild. The Henrietta Lacks Bill will oversee a study into barriers to participation in medical research. Some of those barriers–mistrust and misunderstanding, are both understandable and difficult to address. However, transparency is an excellent place to start.

This is where I am qualified to comment. As someone who has now spent more than a decade in clinical trials, I have had to learn as I have gone along. The difference between a research biopsy and a clinical biopsy? I figured that out a very short time ago, and only because I asked a specific question regarding return of results.

So. It’s good that medical research is having such a moment. But let’s not pretend that something like informed consent is all about the patient. No, it is essentially legal jargon, designed to protect the physician from litigation. The tip off? That word consent, which connotes permission. Because how can you say yes with certainty when you don’t truly understand what it is that you are agreeing to?

And here I go, reacting

Can’t help it, y’all. As I scramble to come up with the money to pay last years taxes, it hurts, actually hurts, to know that those who participate in clinical trials for a COVID-19 vaccine are being compensated.

Read this article from the NCBI and weep. Tell me, again, why it is that those of us who are both unfortunate enough to have contracted terminal cancer and also desperate enough to stay alive that we will do almost anything, are somehow a different story. Are we too not deserving of assistance and recognition “for the fair value of…time and effort expended in research participation?

And how about this paragraph rationalizing compensation for vaccine ‘volunteers’: “Compensation also should be viewed as the ethical default because it helps to minimize the chance participants will be exploited by receiving benefits that are disproportionately low compared to the burdens they undertake and the value they contribute to research. While the prospect of direct benefit is relevant to avoiding exploitation, research benefits are not always present and are never certain. Thus, it often makes sense to compensate participants for their work via a wage-payment model, using a fair local wage for similarly burdensome nonresearch endeavors as a benchmark. This is not intended to make participants better off as compared to their financial baseline or even to fully compensate for participants’ opportunity costs but rather to acknowledge the value of their time and effort. Compensation can also help distinguish research activities, with their distinct goals and risks, from clinical care, signaling that participants are contributing to science and that individual benefit may not result from their research participation.

Um, yeah. I can hope like hell that when I participate in a clinical trial I shall attain some personal benefit, but–particularly in phase I where safety versus efficacy is being assessed–it’s a crapshoot.

So why why why why why why why are cancer patients treated differently? This is a human rights issue. I am/we are more than our tissue. Those of us dealing with advanced cancer are desperately ill individuals who are taking on tremendous risk and burden in order to A. hopefully live longer and B. advance medical research—A being the far dicier of the two propositions.

And then there is this curious sentence: “We argue that reimbursement and compensation should be offered in COVID-19 trials as a matter of fairness, as is true for other types of clinical research.” I’m all for the fairness part but clearly they are talking about medical research with ‘healthy volunteers’, not those of us with cancer.

Thanks to COVID-19, clinical trials are having a big ass moment right now. Let’s not waste this opportunity to have some constructive dialogue per ongoing issues related to medical research such as disparity, accrual and compensation. And while we’re at it, let’s stop hiding the dirty little secret that exploiting cancer patients didn’t stop with Henrietta Lacks.

We can, and should, do better.

Getting it right about research

Medical Research (capital M, capital R) is often the star when cancer patients talk about their continuing survival.

I’ve sung the praises of research again and again. Without it, I’d be dead.

However, the part of the story that often gets glossed over is that medical research requires human subjects. And that particularly in phase I trials (designed to assess safety not efficacy), these human subjects are taking on quite a lot.

MTD, or maximum tolerable dose, is determined in phase I trials. You know how? Someone experiences side effects that are not tolerable. Tolerable is a word with a lot of latitude. As I begin my fourth phase I clinical trial, I can tell you that it takes both courage and an ability to navigate uncertainty and discomfort that frankly, many don’t possess.

Clinical trial participants are the unpaid labor force that moves experimental therapeutics to market. We take on enormous risk as well as additional expense. Our skin in the game is the real deal, from blood draws (thirty teaspoons at cycle one this time) and biopsies, we provide the necessary specimens. We agree to take drugs that no humans have taken before. In exchange, if we are lucky, our lives might be extended—maybe even long enough to enter yet another trial.

Because frankly, if trials are not a one and done, then they become a literal way of life. I have now spent a decade, or one sixth of my life, as a clinical trial participant. That’s a lot of heavy duty community service.

However, it wasn’t altruism but rather a desire to stay alive that led me to my participation. That in no way lessens the contribution though. Veterans of combat are honored for their service, not their motivations.

If we want to have clinical trial participants recognized as partners rather than merely participants, we need to change the way we talk about trials. Don’t just thank medical research, acknowledge as well the contribution of those individuals who ‘volunteer’ their time, tissue and finances. Recognize that medical research simply could not happen without these sacrifices.

Next time you express your gratitude to medical research, try saying this instead: “I would like to thank medical research and all those brave individuals who participated in the clinical trials that brought this drug to market.” It’s a mouthful. But frankly, it’s the least we can all do. Remind the world that without trial participants, research isn’t going any further than the lab. And I’m not just talking tissue, this is all about teamwork.

Honor that.