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 In fact, I learned of a study in the Lancet that was completely suspect due to the methodology was retracted, and that was shocking given their reputation.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. 

 

Half a century

What does it take for a marriage to last 50 years?

I have asked a few people that, and what I usually hear is this:

Patience. Lots and lots of patience. Also, the ability to let go of the need to be right about everything.

I think it was Frida Kahlo’s father who told her that the secret to a good marriage is a short memory.

50 year cakes and flowers

Ten years ago (in 2010) I met the man who would become my husband in 2017. He proposed in 2015. It took me many years of therapy, personal coaching, spiritual growth and a leap of faith for me to enter back into such a contract for a second time.

I read books like “All the Single Ladies: Unmarried Women and the Rise of an Independent Nation” by Rebecca Traister and “Committed: A Love Story” by Elizabeth Gilbert. The first time around, I had known I could get out of it. That marriage was borne of familial rebellion and personal stubbornness.

The second time around, I waited to be sure I could outlast my tendency to get bored and move on every 4-8 years. I already knew living with other people (anyone really) can be difficult for me. Solitude is precious. Personal space is one of my highest values. It’s why the era of COVID-19 has held blessings in disguise for me. I realized this reflects a lot of privilege. It also reflects the personal choice I made not to become a parent.

My parents love my sister and me fiercely and protectively. Their division of labor is not what I would choose, but it seems to work for them. They taught my sister and me that all people are worthy of respect. They contributed to their community in so many ways, especially to their students and neighbors. They focused their attention on us, our educations and our futures. We have never doubted their commitment to us. I am forever grateful for those gifts.

Half a century. I am in awe. Grateful.

cristy@meximinnesotana.com

 

 

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

No time like the present

There is no time like the present.

Actually that’s the only time there is, this present moment. The past exists in your mind as memory. The future only exists in your imagination.

Times like these make that all the more clear to me. The only actions we can take are in the present.

No Time Like the Present

True, we can plan for the future. But our ideas about the future are only a guess. In February, did anyone plan for not being able to get to the gym for a month starting March 17th?

I had to laugh at the U.S. President’s remarks on Wednesday. (Otherwise I would cry. Really.) He’s acting like we can and should “start-up” the economy again just like re-booting a computer. He actually thinks he is in control of the virus and the economy! Wow.

You and I know that is absurd and dangerous.  It becomes all the more clear that when the ego (i.e. left-brained “me-oriented” mental chatter) drives the world, disaster is the result.

Surrender to this moment. Do only the next relevant thing.

The next moment will take care of itself. And you will calm yourself by breathing, not trying to imagine EVERY possible scenario at once.

Think of Dorothy, who said “there’s no place like home.” And close your eyes, feel your feet on the floor, or your butt in a chair and say:

“There’s no time like the present.” Then live your life, one moment, and one breath at a time. Humanity is resilient. You are no exception.

Love you all,

cristy@meximinnesota.com

 

Sunday haiku – detritus (2 versus)

Accumulation:

Detritus that needs taming

Gathered in corners.

***

KonMari says: Once.

But I know myself better.

Collections spread here.

I’ve managed to collect some clutter piles over the holiday season, and I intend to tackle them this weekend, since I find they are interfering with my energy flow. Maybe I didn’t successfully finish the “Kon Mari” work a couple of years ago, or maybe she doesn’t really address the habitual collecting that can be hard to defeat.

***

cristy@meximinnesotana.com