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

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.

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.

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.

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

On July 23rd 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.

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.

Looking for Community that Cares, Creates and Connects?

Yes, NWABR’s goal is to promote the public’s trust in biomedical research and its ethical conduct. But what does that really mean?  How can we achieve this goal?  By building a strong community.

I am passionate about community. I believe that while many of us network and relate to one another through a smartphone, we also crave interactions in face to face settings.  NWABR offers many opportunities for face to face community building: professional conferences, our upcoming Speak Up for Research Gala (Are you in? nwabr.org/annualgala) Student BioExpo, Camp BioMed (sign up your student today), Speakers Bureau engagements and our Community Conversations in Portland, OR and Spokane and Seattle, WA.

In Portland, the Community Conversation Series is receiving rave reviews about our facilitators and topics, but also about the sense of community we are creating.  “Great event.  Will be seeing how I can use this to get others invested in the community.”  Another attendee remarked, “I believe that only by sharing our ideas and thoughts can we grow as individuals and communities.”

Join our growing community by coming to a Community Conversation for the first time or reconnect with us.

Seattle: Tuesday June 9th, “Doctor’s Office Research.  What’s it to you?” Facilitated by Dr. Ben Wilfond, Seattle Childrens. Issues of informed consent and perception of risk in research participation.

Portland: Tuesday Aug 25th (to be confirmed), “Humans and food animals are One Health: Antibiotic resistance development through food animals.” Facilitator TBD

Spokane: Fall 2015 “Humans and food animals are One Health: Antibiotic resistance development through food animals.” Facilitator TBD

Seattle: Fall 2015 “Humans and food animals are One Health: Antibiotic resistance development through food animals.” Facilitator TBD

Chris Rivera, CEO of WBBA Speaks Up for Research: Sites Economic Impact!

Record Year in Washington Life Science Investment Activity Sets the Stage for Life Science Innovation Northwest Conference in June
By Chris Rivera

Since the start of the global economic slide in 2008, the life science industry waited for a sign that the economy has made a turnaround. Last year’s financial activities show without a doubt the recovery is in full swing. In 2014, more than 50 Washington life science financial transactions – IPOs, mergers and acquisitions – amounted to more than $1.6 billion. This financial milestone is more than double the amount generated by 73 transactions in the state’s life science industry in 2013. Of particular note were Juno Therapeutics and Adaptive Biotechnologies, which together raised almost a third of last year’s total financial transaction activity.

In fact, the last two years may be the most active in the history of Washington’s life science industry, a testament to the state’s ability to attract talent and capital in a globally competitive marketplace.
All of this financial activity in Washington bodes well for the upcoming Life Science Innovation Northwest (LSINW) Conference June 30 and July 1 at the Washington State Convention Center in Seattle. The 14th annual LSINW is the largest fully-integrated life science exposition in North America, attracting attention from large strategic partners, venture capitalists and private equity firms to our region’s great innovations in the life sciences.

Despite the early success of Seattle firms such as Juno Therapeutics and Adaptive Biotechnologies and others, it’s often hard for young biotech companies to secure enough venture capital funding and hire more of the nation’s top talent.

LSINW brings together 1,000 life science executives and industry supporters for two days of discussions and relationship-building that helps develop the Northwest into one of the largest globally recognized bio clusters in the world. Currently listed as #7 on the Genetic Engineering & Biotechnology News list of major bio clusters in the world, Washington is considered a rising star by many large investment firms.
With more than 34,000 direct and 90,000 indirect jobs, the life sciences industry is one of Washington’s largest economic sectors, adding more than $7.3 billion to the state’s GDP. Washington is known for the birthplace of commercial jets, the $2 cup of coffee, and software than runs most of the world’s personal computers. Less celebrated are the many scientific breakthroughs that originated here: ultrasound imaging, cardiac defibrillators, and the first bone marrow transplant. The creativity and energy that launched these and many other life-changing products and procedures still exists today, and the future bodes to be even more amazing than the state’s storied past.

I encourage everyone to attend LSINW, June 30 and July 1. Engage in conversations in support of this very important industry for our state. Over the next decade, I truly believe Washington will establish itself as a global leader in life science innovation and health care delivery.

Chris Rivera is President and CEO of Washington Biotechnology & Biomedical Association (WBBA), the life science trade association for Washington State. WBBA has over 650 member organizations in the biotechnology, medical device, health IT, bio-fuel, bio-agriculture and veterinary medicine industries. Further information may be obtained at http://www.washbio.org.