I am not convinced

There are a few vaccine trials that have started in the United States in the Phase 3 stage. I tried to find out more about one of them that was covered by NPR about the COVID-19 Prevention Network. To be honest, I hoped to see some reports on the preliminary results of the Phase I and II parts of the trial.

I could not find any such reports on the website, or any indications of possible adverse effects that could occur in the phase III trial. I signed up to be part of the screening for the trial (and did not receive a confirmation email). There is not a research site near me, so that is probably why. I could not find relevant scientific information, even on the Clinical Trials.gov site where such reports are required to be posted.

COVID-19 prevention network

Quite frankly, I am skeptical. I believe that the only way we can get back to a “new normal” and something like a post-COVID-vulnerable era is to be sure that a vaccine is developed. And at the same time, I would not recommend that friends or family members sign up for a trial conducted by Moderna. According to my sources (which include Wikipedia), Moderna has has mostly unsuccessful trials. In addition, it has been criticized for being secretive and not publishing peer-reviewed papers for its trials.

This is a warning flag to me. It seems like a company that is good at raising a lot of funds, without a lot of results. Science takes time to advance, and it also requires collaboration, not secrecy, in order to work well.

What troubles me is that science that is rushed is not subject to peer review. In fact, I learned of a study in the Lancet that was completely suspect due to the methodology was retracted, and that was shocking given their reputation. I remember reading it and wondering how the data were compiled so quickly given the difficulties in aggregating  from different instances of EPIC and other health data systems. As it turns out, Surgisphere, the company that provided the data was not able to “show their work” and methodology to validate their conclusions.

If you plan to sign up for a trial, my advice is this: be wary. Ask a lot of questions. Make sure you have time to think it over before signing up. Do research on the company and their background. If you are not convinced, do not sign up. Have your own “friendly clinical researcher”* reviewer take a look at the materials you are provided. I am very sad to say that in this era of misinformation and disinformation being published, the public needs to be even more careful.

Wear your masks when in public spaces, wash your hands and take good care, friends.

-cristy@meximinnesotana.com

*And if I do have fellow clinical research colleagues reading these studies and coming up with different conclusions, I would love to hear your feedback as well. 

 

Trials and tribulations

Hi Friends,

I have been wondering how best to use my expertise and skills to be of service during the COVID-19 situation, and brainstorming ways to put my experience to good use in a new job.

Offering yoga online has been very fulfilling, and it has allowed me to contribute to keeping a small business running that had to close acupuncture operations for 2.5 months. I love getting to know my students better and the Sunday (Re)treats have been my favorite.

It has also occurred to me that clinical trials are running for treatments and for vaccines to help save lives and stop the spread of this infection. I have 12+ years of experience as a clinical researcher, and I am good at explaining technical concepts to non-scientists in a way that makes sense. Mission taking shape…

Web MD coronavirus picture
Photo credit – WebMD (COVID-19: What You Should Know)

I have noticed that Universities have difficulty explaining clinical trials to potential participants in ways they understand. Many of their resources are text-heavy and use a lot of technical terms. It is a chronic problem for the informed consent process as well, which is required before volunteering to participate in a trial.

In service to helping people understand which trials might be the best fit, I am considering a series on de-mystifying the clinical trial process. It may be a matter of curating the best content that is available and sharing it. I am strongly committed to advocating for participants who may be confused and want clarification of their questions.

The ACRP (Association of Clinical Research Professionals) explains that with the pandemic looming large at hospitals, many trial sites are not recruiting participants and face the danger of not completing their enrollments. This could have devastating effects on the development of other life-saving therapies outside of this virus.

My questions are these:

  • Have you ever thought about volunteering for a clinical trial?
  • What are your reservations about participating in a trial?

For now, since the biggest question people seem to have for the news media on vaccines and trials is: why will this take so long? I am posting an info-graphic from St. Luke’s which nicely summarizes the process. I’ll be back later this week or next to follow further in bite-sized stories if there is interest in this topic.

phases of a clinical trial
Credit to St. Luke’s Cancer Clinical Trials Center for this graphic

Stay well and safe. Wash your hands. Wear your mask. Be kind.

cristy@meximinnesotana.com

Unwritten protocols

Hello Friends,

Happy Thursday!

I’ve been deeply immersed in a personal writing project so I am likely to post a little less frequently in the few months. I have come to enjoy my Sunday haiku, so I’m not giving that up. We all have much going on in our lives, and YOU are no exception. But I do want to keep in touch so if you do want to connect and I’m taking an offline hiatus, you can reach me via email.

Do you know the unwritten protocols of your organization?

In the meantime, I wanted to reflect on something I posted about last week, an incident in which I was blind-sided at work by something I never saw coming.

Now that I’ve had the chance to think it through I realized I had not respected the unwritten protocols that exist in this organization. As a clinical researcher by training, I have a love/hate relationship with protocols.

Protocols are awesome because they give you a clear definition of what needs to be done. They are written in language that is specific and precise. Since scientific experiments need to be reproducible and consistent in their execution, protocols are a necessity. When you work with human subjects research, regulations require protocols that are well-vetted, statistically validated and approved by an institutional review board or medical ethics committee.

Organizations often have “power protocols” also. These are the unwritten protocols that take typically 6-18 months at any organization or department (sometimes more) to learn. They are things like:

  • Having a PhD or M.D. counts (especially true in academic organizations).
  • If you have a choice to talk with the PI for a grant, or the chief of staff, pick the latter. She’s the one who actually gets the job done; he’s the name on the letterhead. In a university system, it’s fascinating to me how this mirrors a very patriarchal structure.

I had opened the communication channels during a project in which I was gathering feedback. But I did not bank on the fact that, while I was trying to be system-agnostic in my analysis, the department wanted me to fix the tool they already have rather than to select the best tool.

Now that I understand what they want, I can execute on that. I may not agree with the decision, but others with higher grade levels are determining the parameters. And that’s where I encountered one of the unwritten protocols at this institution: if grant money has been used to build a tool, it would take a LOT for us to abandon the tool.

Lesson learned. Onward.

cristy@meximinnesota.com

Workplace Wellness – You have time

I am just coming out of my first two days at my new job, meeting people and learning more about what I have signed up to accomplish. It is exciting and exhilarating.

UofM cube.jpg
My new work space at the University

It is also like one of my colleagues described it, “like drinking water from a fire hose.” There are a lot of new concepts to absorb, and research units to understand, training to complete, and meetings to schedule.

Over the lunch hour, I attended a session from the Office of the VP for Research on Vulnerable Populations. It was a fascinating look at the fact that researchers sometimes take a paternalistic perspective to protect research participants. But we do not always consider the injustice of excluding certain types of candidates for research, and how this may actually deny treatment alternatives.

Fascinating stuff. I can tell this job is going to challenge my thinking and open me up to new perspectives. I love that.

I also know that by the end of the day, around 4:45 p.m. after two full days of meetings, and a mini-celebration dinner with friends for my birthday on Monday, I was wiped. My brain felt worked and tired.

I considered pushing through and working longer. Then I opened my journal and opted for a short reflection on the day, old-fashioned pen and paper style. It helped clarify my thoughts and questions.

On the 12 minute walk to my car to begin the commute home, I considered what might be a helpful mantra, given a slight feeling of being overwhelmed by expectations. Ultimately I decided on “you have time.”

WORKPLace wellness on wednesdays

You have time to learn the new job (and it is okay that you don’t know everything you need to know/do in the first couple days)

You have time to get to know the department.

You have time to map out a strategy and plan.

You have time to absorb the information you need. You were hired because of your expertise, experience and capabilities, not because you know everything.

You have time to enlist the support you need to be successful.

After a few minutes of deep breathing and chanting this simple mantra to myself, it started to resonate in my body. I felt that familiar relaxation response, when my mind starts to believe what I am “feeding” it via conscious thoughts, and my body lets go of anxiety.

The next time you find yourself flipping into a mental script has you feeling overwhelmed, you might tell yourself that “you have time.” See what effect it has on your body, and your feelings. You have time.

cristy@meximinnesotana.com

 

Junk science and nutraceuticals

Lately I have received two completely separate solicitations from a friend and a family member for “nutra-ceutical” products that make claims that are fairly dubious. I am curious about why the information was sent to me, and I am following up to understand this. However, I feel the need to debunk bad science before it harms or scams people.

Terms like epigenetics, biohacking, and reducing oxidative stress are used to draw people into the pseudo-scientific claims they are making. It really upsets me, because the research that they link to their articles does not back up the claims they make. They also prey upon the lack of clinical research knowledge of ordinary people in order to try to sell them supplemental nutrition that we should be getting from real food.

LittleYellowPill.JPG
Promotional blurb from the Facebook ad, trying to capitalize on trusted brands in order to market a product with dubious claims.

It makes me so angry that I am going to go on a bit of a rant here. Pardon me for that, but I do not like to see my friends and family duped into buying or selling expensive products that are totally unnecessary. Because this industry is NOT regulated and does not have to go through FDA or other approvals to be released, I have serious safety and efficacy concerns about these products.

I support medicines or supplements that have been shown to have clinical benefits, as long as the side effects are non-existent or minor. Obviously, as a clinical researcher in the medical device industry for over a decade, I have seen the difference that proper therapy and intervention can make for patients.

But I see also the shady under-belly of an industry that is preying upon the worries and fears of people. There is probably a strong placebo effect in terms of people’s belief that these products may work for them. However, I think consumers waste money unnecessarily on non-proven and potentially dangerous supplements that have not been adequately evaluated.

I have healthy skepticism for the medical establishment. I realize that recommendations are not always in the long-term best interest of the patient. Incentives can be contradictory. I realize that presents a problem. But approval for medicines, devices or supplements should be made based on rigorous study design and tested via randomized controlled trials.

Please be careful when you see claims made that seem too good to be true. When a pill claims to reduce symptoms for Fibromyalgia, Parkinson’s, and dementia, and MS and a host of other conditions, be suspicious. Typically these claims are overblown and would never pass muster in terms of their scientific validity.

End of rant. This has been your weekly PSA from a concerned clinical researcher.

cristy@meximinnesotana.com