Crisis in Antibiotic Resistant Bacteria: Are you Chicken? A Community Conversation Reflection

During the autumn round of Community Conversations in Portland, OR and Seattle and Spokane, WA, we discussed the concern that ongoing antibiotic use in large-scale commercial chicken farms is producing antibiotic resistant (ABR) bacteria that contribute to more difficult-to-treat human diseases. In a 2014 report on antibiotic (ABX) resistance, the World Health Organization warns of humanity heading for a “post-antibiotic” era in which antibiotics can’t keep up with ABR and the diseases they cause.

Who are the stakeholders in this situation? Large- and small-scale farmers, consumers, researchers looking for new drugs that kill bacteria and medical professionals who want healthy patients. With all these stakeholders, how are we to address this potential public health crisis?

The One Health Initiative holds that human, animal and environmental health are all connected. ABX use practices in food animal agriculture are of particular interest, but not everyone agrees that there is sufficient evidence that the use of ABX in chickens (or other food animals) directly results in ABR infections in people.

Despite expected regional differences, participants in the Conversations were united in several areas. One, we simply need more data. The Food and Drug Administration only recently (2009) began collecting sales data for antimicrobials in food-producing animals. No one is sure what is actually being used. Legislation attempts to limit ABX use and require record-keeping both federally and in some states, including Oregon, have not garnered enough support. Two, consumer education needs are high. We are inundated with messaging and food labeling that is sometimes great marketing (rBST-free!—but there isn’t a significant difference in the milk from cows treated or not with rBST) but low on information (how are egg-laying hens treated if they are cage free?). Many of us still believe that if we have a cold for more than 3 days we are good candidates for antibiotics. Three, the conversation tends to use rhetoric that is sensationalized and prevents authentic discussion. For example, “factory farms are overusing antibiotics and are mostly responsible for this crisis.” Toxic rhetoric.

Participants rallied around some practical action items. People committed to investigating the meaning of food labels. People committed to better hand washing and to touching their faces less often (did you know 30% of people carry MRSA in their nose?). Many also committed to sharing their new knowledge both professionally and personally.

All in all, this round of Community Conversations was high in energy and commitment to better living through smarter consumption of food, data and antibiotics.

Many thanks to our facilitators Kathy Hessler, JD, LL.M and Emma Newton, MS (Portland); Heather Fowler, VMD, MPH and Paul Pottinger, MD (Seattle); and Doug Call, PhD (Spokane). Thank you to our Spokane Series Sponsor, Whitworth University.

 

People Not Paperwork: Perspectives from the 2015 Institutional Review Board Conference

On July 23^rd in Seattle, WA co-presented by NWABR and Quorum Review IRB, the Revolutionizing Informed Consent Conference brought together scientists, researchers, ethicists and community members to discuss a way to create a better experience for participants in human clinical trials. The “consent document” is a confirmation of the consent process that explains the nature of the research and any risks and benefits to a participant to communication required throughout, but informed consent is an ongoing process. It starts before any forms are signed, and it continues through the completion of the subject’s involvement in the study. A copy of the consent document is reviewed by the IRB before it is presented to prospective participants.

With her daughter, Marie-Térèse Little, PhD, WIRB scholarship recipient.

Guest blogger and biomed community member Marie-Térèse highlights some of the presentations that were fascinating and thought provoking. We appreciate her contribution, each of the participants attending, our speakers, planning committee, our sponsor partners WIRB, CITI and Fred Hutch, and Boston University for supporting the important work of creating dialog among experts to discuss practical advocacy and compassion for human subjects.

People Not Paperwork

It is clear from the thought-provoking presentations from speakers across North America offered at this year’s conference of Revolutionizing Informed Consent that innovation and technology are indeed starting to revolutionize the informed consent process. These seminars challenged the status quo and how we contemplate this important process in the context of clinical research. Mr. Zachary Hallinan, Director of Patient Communication and Engagement Programs at the Center for Information and Study on Clinical Research Participation, presented Barriers to Change in the Informed Consent Process – a Systematic Review, addressing the barriers to improving consent, general environmental factors affecting patient satisfaction in the informed consent process, instruments for measuring consent and how the current informed consent model impact enrollment in clinical trials.

Mr. Hallinan’s findings concerning the many environmental factors within the consent process affecting patient satisfaction include: limited time to deliberate, feeling overwhelmed by the initial diagnosis, being asked to produce a written consent (for patients with life-threating diagnoses), feeling responsible for their own treatment decision, the physician’s medical language and the structure of the consultation, not enough detail and conversely, and too much detail. It is interesting that some patients simply do not want to be responsible for their decision to enroll in a trial.

Satisfaction appears to result from the actual discussion rather than the document itself. Surprisingly, there is no real evidence to suggest that the informed consent document increases or decreases enrollment; however, there was a positive correlation between the informed consent discussion and enrollment rates. This research is valuable and practical because it reminds us in the research ethics community the value of the entire consent process complete with an open, dynamic discussion, not just a document or a signature. Hallinan’s important presentation was both in-depth and stimulating and culminated with a plea to re-focus on the primary goal of educating and informing participants about the trials so that the decisions they make are truly informed. From his comprehensive research, Hallinan recommends that IRB (and REB) policies and procedures be revised to facilitate collaboration between ethics review communities.

Marie-Térèse Little, PhD is a volunteer member of Island Health clinical research ethics board on Vancouver Island, B.C. She worked at the Fred Hutch developing novel strategies for reduced intensity bone marrow transplants and she now lives in Victoria, BC with her family. Marie-Térèse is the founder and chief consultant at 4th Dimension Biomedical Research Communications (www.4Dbrc.com) where complex bio-medical and scientific information is distilled into clear, meaningful and comprehensible communications. Stay tuned for additional speaker sessions featured this month.

What can your genes tell you? Ask the Portland Community Conversation

October 21, 2014

For the crowd that gathered at the Lucky Lab Pub, the Conversation came down to two things: 1) what is the balance between individual rights to information and Food and Drug Administration (FDA) device regulation with direct-to-consumer genetic testing like that provided by 23andMe? and 2) how will individuals interpret and act upon information they receive from direct-to-consumer genetic tests?

Summer Cox, from the Oregon Health Authority Genetics Program and Shaban Demirel, from Legacy Research Institute, facilitated this Conversation. Summer provided expert information and Shaban reflected on his personal experience using the 23andMe service before its range of health-related services were disallowed.

Some people felt an absolute right to be able to purchase a genetic testing service and receive information about their health risk for diseases, the way their body processes drugs like statins and caffeine and whether they have or ‘carry’ any inherited conditions. After all, “it’s not the FDA’s role to censor knowledge.” There was little debate in the room about the accuracy of genetic sequencing itself; rather people were concerned about the validity and reliability of the meaning of the genetic data provided by 23andMe. Some meaning for raw genetic data was based only on studies of 750 people, maybe not a large enough sample for statistical power; some diseases are not well-studied enough to have full knowledge of the genetic input. The more serious a condition, the higher the stakes for accuracy. Among those concerned, one laid bare the issue using a relatable gasoline analogy: “You want the government to protect you against the bad guys. If you pull into the gas station and buy a gallon of gas, you want it to be a gallon, and you want it to be gas!”—this is the same reason the FDA has ordered 23andMe to stop providing health-related genetic information to consumers—they want the genetic tests to do what they promise and do so accurately.

But then again…is genetic sequencing and interpretation really a device? Maybe the ‘book of regulations’ isn’t broad enough in scope to cover this kind of test.

Attendees were also mindful that once these test results land in your lap, how will you take the information? How will you respond? The company 23andMe is very aware of this concern and when they previously offered the health-related tests, they directed the consumer through a series of deeper and deeper consent to learn their genetic information on more and more serious conditions. As Shaban pointed out, “you cannot unlearn this information.” At one time, 23andMe offered predicted health risk for 122 diseases and 53 inherited conditions. That’s a lot of data to take in for oneself and/or ones children. “What if one of your results is really important? 122 traits? It’s overwhelming emotionally. It’s expensive to follow up on.” Attendees agreed that most people react emotionally first, before their rational brain kicks in to consider the information.

Along the same lines, attendees raised the concern that the meaning of predicted risk for a condition or disease will be read differently person to person. Most people lack a strong understanding of ‘risk.’ Some may be truly scared when they read of their three-fold increased risk for atrial fibrillation over the general population; some will read further and see this only elevates their risk from 1.7% to 5%, which is a small number—but others will be hung up on the three-fold higher risk and panic.

And yet, with all this, attendees acknowledged that there is uncertainty in all things like this—in the meaning of our genetic information and the meaning of health-related tests we take at the doctor’s office. “The public has an inflated sense that the answers our doctors give us are black and white. Maybe bringing to light the uncertainty is a good thing.”

We also shared some laughs. An attendee shared with the whole group that when he was diagnosed with glaucoma, he was in disbelief. He couldn’t process the reality of that diagnosis-given in his doctor’s office– and imagined that many people sitting with 23andMe data might feel the same way. He went so far as to say that he was proposing alternative diagnoses, “Maybe I just have a really big optic nerve!” And that is when another attendee urged from the other side of the room, “Own your phenotype!” The room erupted in laughter.

In the end, we weighed and applied the ethics principles of autonomy and beneficence, enjoyed our pints and chips, joked about hairy big toes—and Hobbits– and dry earwax, and got one another thinking. Some people sent away for 23andMe testing kits. Some wished they could still receive health-related genetic information from 23andMe. And the rest of us went away wondering if we really receive a gallon of gasoline when we pay for one.

Thanks Everyone! See you soon again in Portland…

Jen Wroblewski