5 posts tagged “Policy”

Communicating drug risks/benefits so the message really gets through

Posted February 22nd, 2017 by

Last month, Jim, a member of the PatientsLikeMe Team of Advisors, was invited by Sally Okun, PatientsLikeMe’s VP Advocacy, Policy & Patient Safety, to present at the Drug Information Association (DIA) Pharmacovigilance Conference. He also led a lunch roundtable for drug risk/benefit communications experts.

Sally, who also participated on the roundtable panel, says requests for patients to participate in events and meetings such as this are increasing: “There’s a lot of interest from the pharmaceutical industry and regulators to hear directly from patients about their experiences. Jim’s presentation was quite powerful and provided a perspective that most in the room had not heard before. The positive response from the audience reaffirmed the value of bringing the patient voice into the full lifecycle of drug development.”

We asked Jim to share his experience (from the patient perspective) attending and presenting at the conference. In his own words:

When it comes to treatment options, patients like us routinely face difficult treatment decisions such as: “Drug X can treat symptoms of your chronic condition and might improve your long-term prognosis. But, 5% of patients on Drug X experience serious side effects, and in rare cases, complications can be fatal.  So: is this a risk you’re prepared to take?”

Question: Now, suppose you worked for a pharmaceutical company or the FDA and were assigned to inform patients like us about Drug X’s drug safety and risks/benefits: what should your primary goal be… provide clear, comprehensive and scientifically accurate advice about all of Drug X’s pros and cons?…OR… help patients review and evaluate information from any source — not just your communication, but also sources like WebMD, PatientsLikeMe, friends and family, and social media — in order to make more effective treatment decisions for themselves?

For participants attending the Drug Information Association (DIA)’s Pharmacovigilance Conference January 17‑18, 2017, this wasn’t a hypothetical question, because their job is to design and develop drug advisory communications for patients and providers.

I recently joined PatientsLikeMe’s Team of Advisors for 2017 and belong to three PatientsLikeMe patient communities (MS, chronic lymphocytic leukemia, and aortic valve insufficiency). My plenary presentation focused on how patients would answer the question above — or, more accurately, how I would answer it.

I began by asking conference participants to raise their hands if they’d ever taken a medication (100%); how many had ever read an entire drug insert from start to finish (≈ 2%); and finally, how many had read a few targeted sections of a drug insert (≈ 50%). The key points here were that (1) regardless of what information they should seek in an ideal world, practically all patients, even if it’s only for a headache or a chest infection, tend to “zero in” on just the information that seems most vital to them for making a treatment decision. And, (2) in the case of serious chronic conditions, the way newly-diagnosed patients “zero in” is dramatically reduced; so, (3) safety communicators should focus more on helping patients recognize the  value of considering more useful information rather than less when reaching a genuinely effective treatment decision, and feel confident in their ability to evaluate any source of information available to them.

To illustrate, I walked conference participants through four treatment decisions I’ve personally had to make to show in each case: (a) what objective information — a tiny fraction of everything available — I actually considered, (b) how my emotions (shock, fear, anger, confusion, etc.) had influenced the way I weighed that information, and (c) the one or two factors that turned out to be key to reaching a decision that was both effective and emotionally sustainable for me.

For instance, when diagnosed with chronic leukemia, I was invited to join a clinical trial.  The key objective information I considered included:

  • Risks of the trial (identified and unknown)
  • the +’s and –‘s of standard 1st-line treatment
  • Requirements for participation
  • Costs of participation.

Emotional factors which dominated my thinking at the time included:

  • Desire for the longest possible remission
  • Logistical complexity of participation
  • Perception of this doctor’s stake in having me join the trial
  • My desire to be a good citizen-hero

And, in the end, the driving factor which influenced my decision not to participate in the trial was the fact that the trial’s logistics would have been incompatible with my work life.

After reviewing three other key treatment decisions in the same manner, I summed up three key observations from the patient’s point of view that drug safety communicators should keep in mind when designing their communications:

  1. Personal, emotional and family factors dominate most patients’ perceptions of the objective information they look at
  2. Since major health care decisions are made under the press of time and powerful emotions, they generally have less to do with objective facts about a medication than the patient’s feeling about what’s best
  3. Objective information about a treatment’s +’s and –‘s counts, but only at certain points in the patient’s decision-making process if/when s/he feels calm and self-confident enough to do so

With these in mind, my key takeaway for conference participants was that they should design their drug safety communications first to help patients find a calm, centered place from which to consider and weigh drug information from any source, and only second to focus on the most important, scientifically accurate information about a drug’s risks-benefits. Those would be my priorities for drug communicators…. but would you agree?

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Largest Patient Poll on ACA Shows Patients Value Health Care Law More Than the General Population, Are Less Inclined to Want a Repeal

Posted February 7th, 2017 by

Lowering Costs, Coverage for Pre-existing Conditions Remain Top Priorities; If Changes Are Required, Individual Mandate Should Go  

CAMBRIDGE, Mass., February 7, 2017—As Congress and the White House continue to discuss potential changes to the Affordable Care Act (ACA), PatientsLikeMe revealed results from the first large-scale poll to assess patient priorities for the health care law. The poll’s 2,197 respondents are among the estimated 133 million Americans living with chronic conditions.

Sally Okun, PatientsLikeMe’s Vice President of Advocacy, Policy and Patient Safety, said the poll gives voice to those who may be most heavily impacted by changes to the law. “Regardless of your political leaning, the great equalizer is that we’ll all become sick one day. At this time of uncertainty about the future of health care, listening to the voice of patients today will illuminate the path forward for all of us.”

Key findings from the poll show that overall, patients have the same concerns as the general population about health care costs, but see benefits in the law that the healthy may have overlooked:

  • More than half (57%) believe the ACA has been helpful to people living with chronic conditions.
  • Nearly half (46%) feel the ACA needs only minor modifications to improve it.
  • Over the last year, their out-of-pocket expenses for health care have either stayed the same (47%) or increased (43%).
  • Lowering costs is a priority for both patients in the PatientsLikeMe poll and for the general population, which took part in a December 2016 Kaiser Health Tracking Poll. Lowering the amount individuals pay for health care is an important priority for 94% of patients and 93% of the general population. Lowering the cost of prescription drugs is an important priority for 96% of patients and 89% of the general population.
  • Nearly half (46%) of PatientsLikeMe poll respondents felt that a repeal of the 2010 ACA “should not be done,” while one third (31%) of the Kaiser general population felt it “should not be done.”
  • When asked which one component of the ACA they would eliminate if they were forced to choose, PatientsLikeMe respondents were four times more likely to say they would eliminate the individual mandate vs. other components of the ACA.
  • When asked which one component of the ACA they would keep if they were forced to choose, PatientsLikeMe respondents were six times more likely to say they would keep mandatory coverage for pre-existing conditions vs. other components of the ACA.
  • The widest differences in opinion related to questions about a repeal of and government involvement in health care law, and were found between the general population, non-condition specific patients, and those who reported major depressive disorder (MDD) as their primary condition:
  • Of those living with MDD, 59% said that the health care law should not be repealed, vs. 45% of the overall PatientsLikeMe respondents and 31% of the Kaiser general population.
  • 42% of respondents living with MDD said decreasing federal government spending on health care should not be done, vs. 29% of the overall patient population and 18% of the Kaiser general population.
  • As for reducing the federal government’s role in health care, 37% of patients living with MDD said it should not be done, compared to 28% of the overall patient population and 20% of the Kaiser general population.

Okun said that patients living with MDD may have a stronger opinion about healthcare law given the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act (MHPAEA), a law passed by Congress in 2008 and codified into rules in 2013 to ensure equal treatment coverage for mental illness and addiction. According to the National Alliance on Mental Illness (NAMI), before the law, “mental health treatment was typically covered at far lower levels in health insurance policies than physical illness.”

Full survey results and graphics are available at http://news.patientslikeme.com.

PatientsLikeMe Poll Methodology
Between January 23-27, 2017, PatientsLikeMe fielded a 19-question poll to a sample of its members in the United States who are living with chronic or progressive degenerative conditions. A total of 2,197 patients completed the poll, which asked both original questions and questions from a December 2016 Kaiser Health Tracking Poll to compare patient and general population responses.

Respondents had a range of chronic or progressive medical conditions and listed their primary condition as multiple sclerosis (13%), fibromyalgia (12%), Parkinson’s disease (6%), major depressive disorder (5%), ALS (5%), type 2 diabetes (3%) and multiple myeloma (3%), among many other conditions. The mean age of respondents was 54.5 years (the range was 18- >89). Of 1,840 respondents who gave information on level of education (83.8% of total), 1.0% had less than a high school diploma, 11.0% had high school diplomas, 38.3% had some college, 27.7% reported a college degree, and 22% reported post-graduate education. About one-third (36%) of patients had health insurance through their employer, one-third (35%) had Medicare; and the rest had a mix of other health care coverage including Medicaid, VA, military, and direct pay insurance, which includes insurance purchased from ACA exchange programs. A very small percentage (2.5%) of respondents said they had no health insurance. Nearly all respondents (95%) are registered voters. Their party affiliation is as follows: 37% say they are Democrats, 19% are Republicans; 15% are Independent; 13% preferred not to say; 11% are unaffiliated and 4% are Libertarian.

About PatientsLikeMe
PatientsLikeMe, the world’s largest personalized health network, helps people find new options for treatments, connect with others, and take action to improve their outcomes. The company has worked with every major pharmaceutical company and a range of government organizations to bring the patient voice to research, development and public policy. With 500,000 members, PatientsLikeMe is a trusted source for real-world disease information and a clinically robust resource that has published more than 100 research studies. Visit us at www.patientslikeme.com or follow us via our blog, Twitter or Facebook.

 


PatientsLikeMe Names Marni Hall Senior Vice President

Posted July 11th, 2016 by

Former Director within the FDA to Spearhead Company’s Research and Policy Initiatives

CAMBRIDGE, Mass., July 11, 2016—PatientsLikeMe announced today it has appointed Marni Hall, PhD, MPH, as its new Senior Vice President of Research and Policy. A distinguished research scientist and public policy expert, Hall will develop and direct the strategies and teams focused on expanding the role of real-world evidence in precision medicine, and in the research agendas of PatientsLikeMe and its customers.

Hall joins the company from the U.S. Food and Drug Administration (FDA) where she was most recently Director of Regulatory Science within the Office of Surveillance and Epidemiology (OSE) for the FDA’s Center for Drug Evaluation and Research (CDER). In this role, Hall became an expert at sourcing and analyzing big data sets, including adverse event reports, claims, -omics, and other data useful to risk assessment and risk management activities. She led data management and program operations, as well as research and development efforts to identify, evaluate, and implement new data, tools, and methods to support regulatory decision making. Specifically Hall’s team explored big data sources such as the FDA Adverse Event Reporting Systems (FAERS) and the Sentinel Initiative, and led post-market safety studies and programs using observational data to gain insight into drug safety and drug performance.

PatientsLikeMe CEO Martin Coulter said Hall “will now apply her strategic research and operational expertise to help us work with our members and partners to use patient-reported data in new and innovative ways, so that the patient experience can lead to even more significant developments and discoveries, such as improved outcomes.”

According to Hall, the new opportunity allows her to continue to do research in a scientifically-rigorous and patient-centered setting. “PatientsLikeMe has been a critical force in documenting and analyzing real-life patient experiences and evolving the role of real-world evidence in clinical and public health research. My goal is to extend its impact, so that the patient experience drives a future where healthcare is able to emphasize individual needs and preferences. I’m thrilled to join a company that is so focused on helping people thrive each day, while collecting data essential to this emerging field,” Hall said.

A research scientist by training, Hall has spent nearly two decades at the intersection of science and policy. She started her career studying toxicology and molecular epidemiology at Columbia University. After serving as Program Director in the Public Health Group of External Medical Affairs at Pfizer, Hall joined the FDA’s Office of Planning and Informatics (OPI) in 2008 as a Principal Analyst. In this role, she initiated and led the development of CDER’s data standards plan. She was appointed Director of Regulatory Science in 2011.

Hall holds bachelor of science degrees in chemistry and in society, technology, and policy from Worcester Polytechnic Institute. She also holds a master’s degree in public health from Columbia University’s Mailman School of Public Health as well as a master of science degree in biochemistry and a PhD in toxicology from Columbia University’s Graduate School of Arts and Sciences.

About PatientsLikeMe

PatientsLikeMe is a patient network that improves lives and a real-time research platform that advances medicine. Through the network, patients connect with others who have the same disease or condition and track and share their own experiences. In the process, they generate #dataforgood: data about the real-world nature of disease that help researchers, pharmaceutical companies, regulators, providers and nonprofits develop more effective products, services and care. With more than 400,000 members, PatientsLikeMe is a trusted source for real-world disease information and a clinically robust resource that has published more than 70 research studies. Visit us at www.patientslikeme.com or follow us via our blog, Twitter or Facebook.

Contact
Katherine Bragg
PatientsLikeMe
kbragg@patientslikeme.com
+1.617.548.1375


#ChatActChange: empowered to chat, act and make change – together

Posted November 17th, 2015 by

On October 28, Sally Okun, our Vice President for Advocacy, Policy and Patient Safety, participated in a Twitter chat – using the hashtag #ChatActChange – aimed at empowering people living with chronic conditions to advocate for policy change. Hosted by Diabetes Social Media Advocacy (DSMA), other chat participants included policy expert Susan Dentzer, Diabetes Hands Foundation and Novo Nordisk.

The chat generated some great conversation about what it means to be an empowered patient. 186 people joined the discussion, including patients, diabetes influencers and policy experts. 2015-2016 Team of Advisors member Christel, who is living with type 1 diabetes, took part in the chat, as did the American Diabetes Association.   

More than 500 users were reached with the #ChatActChange hashtag, and there were more than 1,154 tweets during the one-hour Twitter chat.

To check out a complete summary of the chat, take a look at this Storify. You can also contribute to the ongoing conversation on Twitter using #ChatActChange.

Let’s be empowered to chat, act and make change – together.

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Sally Okun reports back from the FDA Patient-Focused Drug Development Public Meeting on IPF

Posted October 16th, 2014 by

On September 26th I was at the FDA for the Patient-Focused Drug Development Public Meeting on IPF. This is one of 20 meetings that the FDA is holding to learn directly from patients and their caregivers about daily life with the specific condition’s symptoms and treatments. (You can learn more about these meetings here.) I have attended a number of these meetings and often have meaningful data to share from our own PatientsLikeMe members. So far, however, the FDA has only allowed patients and caregivers to present and participate as panelists.

So to get as much of our members’ real-world health data in front of the FDA as possible, I take full advantage of the public comment period at the end of each meeting. It’s a short 3-5 minutes of time, but it’s a chance to share insights from PatientsLikeMe members and to reflect on some of what’s been discussed during the public meeting. In addition, we submit a full report to the FDA’s public docket that is open for comment two full months following the meeting. The report includes a community profile and the results of any polls PatientsLikeMe members have taken part in prior to the meeting.

This meeting was different
It was my pleasure and privilege to meet and spend time with a member of our PatientsLikeMe community who was selected by the FDA to be one of the panelists. LaurCT did an amazing job sharing her challenge in getting an accurate diagnosis – which took a number of years. She also shared with the FDA and all the folks in the room that she did not learn about the Center of Excellence for IPF located only an hour from her home from her now former pulmonologist after finally getting the diagnosis of IPF – she learned about it from other IPF patients on PatientsLikeMe. (Thank you for sharing Laura!)

Many in the room acknowledged that a cure may not be found in their lifetime but they also conveyed to the FDA a palpable sense of urgency for treatments to slow the progression of the disease to reduce their symptom burden and increase their ability to participate more fully in life. What was startling was how often people shared how the lack of knowledge about IPF among physicians – even among pulmonary specialists – led to delays in their diagnosis and for some resulted in misdiagnosis and inappropriate treatment.

One specialist, Dr. David Lederer, co-director of the interstitial lung disease program at Columbia University Medical Center in New York City and well known to many patients in the room for his work in IPF, used his few minutes in the public comment period to call for therapies that help his patients “live longer, healthier, more normal and independent lives.” He provocatively said that “oxygen should be free” and called for more study of the benefits of oxygen combined with exercise which today are the only things that help people with IPF actually feel better. This was borne out in our poll as well.

A family thing
In addition, there is an important familial connection that many feel is not getting sufficient attention in research. One woman shared her family’s story starting with her father’s diagnosis and death followed by the deaths of each of his 4 brothers of the same disease. A number of people talked about family members who died over the years with similar respiratory symptoms and questioned whether they in fact may have died of undiagnosed IPF.

Your voices transformed
While the opportunity for patients to be heard cannot be diminished, I along with others in policy and advocacy circles remain concerned by the anecdotal nature of these FDA proceedings. At each meeting, there are a few polling questions with audience clicker devices, but there is no systematic way of transforming the very powerful patient narratives that are shared into meaningful and usable data. At PatientsLikeMe, your stories and your voices are best amplified and speak most loudly when transformed into data that is both meaningful and measureable.

All that said, it’s worth watching the free webcasts of the meeting, which you can find here.

PatientsLikeMe member SallyOkun

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