The War on Drug Prices

Cost of Drugs_cartoon
Most Americans ask the question, is the price I pay for prescription medications FAIR? In other words, what is the true cost of developing, making and selling a medicine, AND how much profit seems reasonable? This is what we tackled last week during our Community Conversation with experts from the U of Washington’s International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

KEY FACTS THAT INFORMED OUR DISCUSSION
Tufts estimates that it costs $2.6 billion to develop an FDA approved drug, a number that increases 9% per year.  People in the US pay more for drugs than people in other countries for a few reasons: 1) we use more medications because we have better access to new ones, 2) we have a higher burden of chronic disease like diabetes and obesity, and 3)  in the US, the government protects drug manufacturing monopolies and limits price negotiations while other countries have more price regulation.

Another reason people in the US (and in Canada and Europe) pay more for medications is simply because, on the whole, we can afford to. Picture a world map, and picture all the people who live on Earth.  At 326 million, the US population is 4.4% of the world’s 7.5 billion people, but the US accounts for 50% of all medication sales in the world. Mind blown.

We are looking for VALUE in our medications.  We want medications that are novel and offer leaps of improved quality of life.  We are willing to pay more for medications that achieve this high bar, but there is a point for every person where price will exceed our ability to purchase a medication.

Finally, we learned about the trade-off between innovation and access.  Monopoly protection funds innovation. In turn, industry creates more new drugs in the long run that cost more money in the short run and poorer access. “But if new medicines aren’t invented, then no one can access them in the long term.” (ISPOR)  How can the market incentivize innovation if not through the almighty dollar?

DISCUSSION THEMES
Many in the room were for the first time faced with the reality that the US foots HALF the bill of medications in the world.  I don’t think anyone, besides the facilitators, was prepared for this data.  As the discussion dug deeper, we realized that our drug costs fund innovation of new medications and devices.  Despite the relationship between US drug prices and world drug innovation, many participants still did not think it FAIR that people in the US pay more than those in other countries.

Some held high the banner of altruism and seemed happy having the US play this role.  Others felt perhaps that even within the US that medication prices should be on a sliding scale based on what a household could afford.  Some shared personal stories about themselves or people they know who have had to choose between paying for their medications and paying other bills.

Yet others remained firm that prices could drop while maintaining innovation if pharmaceutical companies could lower their profits to reasonable margins.  Some attendees implied that companies could reduce their expenses by accelerating the clinical research process, a point that was strongly opposed by a former industry employee.  Pharmaceutical companies have no interest in accelerating clinical research in this manner because it would cause less confidence in drug safety.

As we were wrapping up our Conversation, we faced the question of whether or not the way we finance medications is sustainable.  Our vocal attendees had faith in the free market to correct anything that was broken.  Others remarked that the balance of medications on and off patent would also help with price competition once medications go off patent.

Our ISPOR facilitators emphasized that drug pricing is a complex ecosystem.  They recommended that consumers, scientists, policy-makers and health care providers and administrators continue to learn and share their perspectives, in venues such as Community Conversations, as much as possible in order to find a stable and sustainable relationship between medication access and innovation.

To read some excellent resources on the topic, visit the Community Conversation archive and scroll until you find the “war on drug prices” topic.

~JenWroblewski

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NWABR conference sits at the intersection of technology, ethics, and policy

The “Ethics and Regulation in the Digital Age” conference, co-presented by NWABR and Quorum Review, brought together researchers, regulators, and IRB professionals to discuss the challenges and potential benefits of emerging digital and mobile health (“mHealth”) technologies for biomedical research. Conference presenters represented a range of topics and perspectives, including on-the-ground researchers, federal regulators, and institutional officials. Max Little (MIT) and Joaquin Anguera (UCSF) presented primary research using mobile health technologies as recruitment tools, data collectors, and interventions. Cheryl Grandinetti (FDA) and Misti Anderson (OHRP) gave overviews of what federal agencies are doing to stay up to speed with digital and health technologies, including human subjects protection. Malia Fullerton (UW) provided insight into the ethical dimensions of the Precision Medicine Initiative, including participant consent and return of results. Eric Mah (UCSD) and Jeremy Block (Sloane-Kettering) discussed ways for IRBs and researchers to communicate risks and benefits of research with mHealth technology. Finally, Catherine Hammack and Kathleen Brelsford (Duke) presented ongoing research aimed at better describing risks and protections to participants involved in genomic research.

 

A few weeks has passed since this stimulating day of talks and networking. Many themes have stuck with me. First, we should all keep our sights on ensuring that emerging technologies don’t widen or exacerbate existing inequalities (e.g., health disparities and access to research and care). Dr. Anguera’s targeted expansion of his “Neuroracer” video game intervention to Hispanic/Latino populations is an excellent example. Second, policies need to balance patients’ and participants’ privacy with the collective benefit of leveraging their data for research. Dr. Fullerton’s presentation underscored how challenging this balancing act can be, specifically with the imminent recruitment of a 1M+ US citizens to the Precision Medicine Initiative Cohort. Third, the rapid pace of innovation means we will inevitably put technologies into use — in research, clinical, and everyday contexts — before we fully understand them. Despite the unease of “building the plane as we fly it,” so to speak, the alternative of holding back the technology may be even more problematic. As keynote speaker Dr. Little put it, waiting for the perfect technology may be unethical, akin to “withholding treatment,” and instead we should utilize what we have now despite the imperfections.

In light of these concerns, I have been wondering how much of this is new versus existing controversies and tensions wrapped up in shinier, newer technology? A set of comments by Dr. Block sparked this question in my mind, when he articulated different “tiers” of technology use in research. In some instances we are using mobile or digital technology to do the same research activities as before, just on a different platform (e.g., a web survey versus pen and paper). In such cases, the technology may be distracting us into thinking that the ethical or policy dimensions of these activities have shifted. In many cases perhaps they actually haven’t. The first step when considering any technology use in research is to parse what is new versus old and differentiate between aspects of the platform (e.g., smart phone) versus the research activity (e.g., recording steps taken).

I don’t envy the job of IRBs having to fit cutting-edge research proposals into potentially outdated regulatory frameworks. But at the same time I wonder how much technological novelty may be blinding us to the similarities with what we already know and recognize as ethical and regulatory concerns. Patient privacy, data sharing, informed consent, potential misinformation, etc. Granted the pace and scale of these problems is increasing with our new mobile and digital tech. But as we move forward, let’s make sure we’re taking with us decades of bioethics and policy thought leadership and knowledge.

Sarah Nelson is a PhD candidate in Public Health Genetics at the University of Washington. Follow her blog at myopenreadingframe.com or on Twitter at @blueyedgenes.

Conflict of interest: Ms. Nelson received discounted access to the conference in return for writing a blog post.

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, How Bacteria Become Resistant to ABXWA, 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.

 

Agreement Doesn’t Mean Consent at NWABR and Quorum Review IRB Conference

by Marie-Térèse Little, PhD

The ultimate purpose of the informed consent process in research involving human participants (subjects), is to provide information to the participants about the purpose of the research, its procedures, and the risks, potential benefits, and alternatives so that the individual understands this information and can make voluntary decisions whether to enroll and continue to participate in a given clinical trial. This informed consent process should allow for rational decision making and foster self-determination and an expression of autonomy. It should include information that is reasonably expected; not only a document of consent but an opportunity for a meaningful and intuitive discussion between the researcher and the potential participants with sufficient time allowed for questions and concerns. Participants should ultimately be given the opportunity to obtain, understand, and to act on the information.

At the Revolutionizing Informed Consent conference, there was a general consensus from all the speakers that our current approach to the informed consent process is troubling at best and it is clearly not serving our participants well.

Poignantly acknowledged by every speaker, the audience was reminded that the current models employed to “obtain consent” involve static, long (often over 20 pages), complex documents that are filled with dense, scientific and medical language and confusing regulatory and legalistic jargon. The informed consent document (ICD) is often a defensive deed designed to protect the institutions and the sponsors rather than protecting the participants in a proactive manner. Emphasis is on disclosure rather than learning. The complexity and length of the ICD results in poor readability. Furthermore, the needs of the participants vary greatly and the inflexible templates of the ICD often involve over explanations of the worst-case scenario. This is compounded by the short windows of time allotted to convey the overall message and the difficulty in quantifying what the participant really understands about the study and what they have consented to. Agreement without understanding is not consent. – JLWilbanks.

These difficulties encountered by participants, researchers and the ethics review community in the informed consent process were unambiguously acknowledged and openly demonstrated in the Keynote address titled “Informing the Research Participant: Emerging Models, Trends, and Regulatory Requirements” delivered by Mr. Kevin Hudziak, Emergent Strategy Consultant and leader of the Informed Consent Transformation project at Eli Lily and Company. Mr. Hudziak also questioned the current approaches and suggested that we, as Institutional Review Board (IRB) or Research Ethics Board (REB) members and staff, researchers and investigators, regulatory personnel and sponsors, need to uncouple Informed/Consent and treat it not as a single incident but an ongoing process that informs first and consents second. The Keynote address also served to introduce the trends in informed consent including e-consent and tiered, progressive, remote, and dynamic consent and the concept that innovation and technology can be leveraged to revolutionize the informed consent process.

 

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. This is her last entry for this conference. We thank her for her time and talent in serving her regional biomedical community, and the Western IRB for providing supplementary funding for her and other participants in 2015.

User Centric Makes All the Difference at NWABR and Quorum Review IRB Conference

by Marie-Térèse Little, PhD

The 2015 Revolutionizing Informed Consent Conference session topic Emerging Trends in Research given by Mr. John Wilbanks was especially riveting. Mr. Wilbanks is Chief Commons Officer at Sage Bionetworks and he has focused his career on advancing open content, open data and open innovation systems. With a bridge grant from the Robert Wood Johnson Foundation, Sage Bionetworks developed and maintains the Participant-Centered Consent (PCC) toolkit . The toolkit was built for architects of clinical studies who are interested in leveraging technology and employing electronic consents in a mobile context with the goal to make their informed consent user-centered, rather than document-centered. Wilbanks demonstrated that the publicly available PCC toolkit contains the building blocks of a visual, interactive approach to informed consent that creates visual summaries of consent forms mapped to key underlying text, for use in software or print. Visual summaries can assist with clarifying key research concepts so the participant is engaged, well-versed and cognizant of the risks, benefits and alternatives of a clinical study. A mixture of icons and text labels are designed to convey the essential concepts of a study in a more intuitive manner facilitating a meaningful and fulsome conversation about informed choices. The toolkit is used to develop mobile-centric informed consent processes for the collaborative clinical studies involving Sage Bionetworks. The tools are used to assist the learning in the consent process and include: tiered information accessed by the participant, pictorial dominant first tier information (with icons, text slugs and labels), a text dominant second information tier and a short learning assessment. The PCC toolkit was developed with the Electronic Data Methods (EDM) Forum, a project funded by the US Agency for Healthcare Research and Quality as a part of the Collaborative Methods Project. With this framework, one can only imagine our participants eagerly participating with fascination and engrossed in this engaging e-consent informed consent process.

 

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 featured speaker sessions.

Simple Words Make a Difference at NWABR and Quorum Review’s IRB Conference

by Marie-Térèse Little, PhD

Dr. Charlotte Shupert, Product Manager for Compliance Solutions, Evisions Inc. effectively outlined some real-world best practices necessary for a true informed consent process in her session titled How IRBs, Institutions, Sponsors and Subjects Impact What is Required in Consent Forms at this year’s NWABR IRB Conference. Among other practical recommendations, she was emphatic that we need to write good consent forms, conduct a good consent process and find out what the participants understand. Furthermore, she expressed that the e-consent form absolutely needs to be in an active voice, readable, with lay language at a level of literacy that reflects a 5th to 8th school grade level (with brief sentences and words with few syllables), in standard font sizes, headers and margins. Whenever possible, the electronic document should use supplements to the text such as videos, tables, graphs, pictures, drawings and schematics. An absolute necessity is a tool to evaluate the understanding of the participant and the “teach back” method was recommended. Her presentation was both witty and serious, factual and candid, and it was a pleasure to hear her recommendations.

 

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 featured speaker sessions.

Speak Up For Research Education Fund

How did science hook you?

Strawberry DNA extraction

Strawberry DNA extraction

Did you have a teacher whose lab was your favorite place to hang out in high school? Were you a biology graduate student who fought for better treatment of animals and found a calling in animal care or health ethics? Did you travel and see suffering that would be diminished with the right vaccination?

I got hooked as a member of the St John Ambulance Brigade in New Zealand where as a teenager I was able to volunteer in ambulances, hospitals and rest homes and saw evolving treatments driven by research.

I’m both excited about science and concerned about its future. I see a growing distrust in biomedical research, waning science literacy and an almost perverse celebration of anti-science sentiments; this all of course at a time when new biomedical research breakthroughs are occurring on a daily basis. Here at NWABR, we see the possibilities of science and are excited by the opportunities for young people to get hooked into fascinating and important science fields—but we also see a gap in the science education for the general public that results in twisted logic, misinformation, hijacked conversations and bad policy decisions.

NWABR bridges that gap, combats that misinformation, and leads spirited and informative conversations about complex issues related to biomedical research.  And we need your help.

Today, I’m asking readers you to join our newest fundraising initiative: the Speak Up For Research Education Fund.  Over the last two years more that 1,400 people have joined NWABR at a series of events:

  • Perhaps they volunteered for our popular Bio Expo that engaged close to 700 high school students;
  • Or they attended a Community Conversation on the ethics of end of life care, or vaccinations, or direct to consumer genetic testing.
  • Perhaps they are a professional dedicated to ethical protections for humans and animals in research and you attended one of our research conferences;
  • Or they attended our Security Conference and joined colleagues from across the country who are committed to keeping scientists, their facilities and their work safe.

This campaign to create a Speak Up For Research Education Fund is about protecting the belief and trust in biomedical research and ensuring that this work can continue robustly into the future.

Join the Speak Up For Research Education Fund and make a donation today by visiting:  https://donatenow.networkforgood.org/nwabr?code=Speak%20Up%20For%20Research

Alternatively you can send a contribution to the Northwest Association for Biomedical Research, 2633 Eastlake Ave E., Suite 302, Seattle WA 98102.

All supporters will be thanked by name in our public materials, unless of course they request to make an anonymous contribution.  All contributions will also be acknowledged with a tax deduction receipt.

This is a vital time for science – with the support of the Speak Up For Research Education Fund we can continue and expand the work of engaging students, families and communities with science.  With the support of this fund then one student at a time, one family at a time, one community at a time we will build support for, and trust in, biomedical research.

Thank you for Speaking Up For Research.

Kind Regards

 

Ken Gordon – Executive Director

Northwest Association for Biomedical Research

(P) 206-957-3337 (C) 206-595-2450