Generation Patient Awarded a $250,000 PCORI Engagement Award for Project on Engaging Adolescents and Young Adults with Chronic Conditions in PCOR/CER for Peer Support Intervention 

Generation Patient has been approved for a $250,000 funding award through the Eugene Washington PCORI Engagement Award Program, an initiative of the Patient-Centered Outcomes Research Institute (PCORI). The funds will support Generation Patient in building the capacity to engage in patient-centered outcomes research and comparative effectiveness research (PCOR/CER) to assess peer support as a crucial intervention for young adults with chronic conditions.

Sneha Dave, executive director, and Sydney Reed, director of operations, will lead the engagement project at Generation Patient. The project, led entirely by young adult patients, will: 

  • Form a multi-stakeholder group of adolescent and young adult (AYA) patients, medical professionals, and researchers to engage in a two-year Roundtable on Peer Support for Young Adults with Chronic Conditions in which they will identify the need, current challenges, and opportunities to develop future peer support PCOR/CER

  • Co-develop Proceedings document to outline findings of the Roundtable discussions

  • Co-develop Peer Support Toolkit to further engage patient stakeholders by helping them to create their own peer support networks.

  • Co-develop a strategic planning document for future peer support PCOR/CER that incorporates the priorities and needs of AYA patients and other stakeholders

“Our team has been working to transform our organization into a more holistic and expansive source of support for young adults with chronic and rare conditions,” Sydney Reed, director of operations at Generation Patient said. “A major part of this work has been not only to create more sources of peer support for our demographic but also to bring understanding to healthcare professionals about the importance of this support as a critical intervention in the care of young adult patients.” 

Over the last couple of years, Generation Patient has held over 450 peer support meetings for adolescent and young adult patients. This grant will enable us to bring together patients, providers, and researchers to develop concrete outcomes for furthering peer support as a valued intervention for AYA patients. 

Through the Engagement Awards, PCORI is creating an expansive network of individuals, communities and organizations interested in and able to participate in, share, and use patient-centered comparative clinical effectiveness research (CER). Generation Patient was one of several organizations awarded funding under a new Engagement Award funding opportunity focused on supporting small organizations, in particular those that may not have any prior experience with patient-centered CER, to build their capacity to participate in this research. PCORI will support recipients with technical assistance and learning network activities across their project period. 

“Small organizations offer unique perspectives and capabilities as partners in comparative clinical effectiveness research,” said Greg Martin, PCORI’s chief of engagement, dissemination, and implementation. “We look forward to supporting Generation Patient in their activities and their exploration of ways to contribute to future CER.”

Generation Patient’s project and the other projects approved for funding by the PCORI Engagement Award Program were selected through a highly competitive review process in which applications were assessed for their ability to meet PCORI’s engagement goals and objectives, as well as program criteria. For more information about PCORI’s funding to support engagement efforts, visit http://www.pcori.org/content/eugene-washington-pcori-engagement-awards/.

PCORI is an independent, nonprofit organization authorized by Congress in 2010 to fund CER that will provide patients, their caregivers, and clinicians with the evidence needed to make better-informed health and healthcare decisions. PCORI is committed to seeking input from a broad range of stakeholders to guide its work. 

We are looking for a new executive director!

Generation Patient seeks an innovative leader with the experience, ability, and courage to champion and guide the next phase of our work. Building on the work of Generation Patient’s founders, the new Executive Director will be a values-aligned and compassionate leader who will uphold our mission of empowering adolescents and young adults with chronic medical disabilities.

The ideal candidate will have a passion for Generation Patient’s mission, growing from their own or other’s lived experiences. Please email edsearch@generationpatient.org with any questions and send in applications by November 30, 2023.

More about our organization:

Our 2022 Annual Report

Generation Patient is a nonprofit organization that facilitates events, programs, and advocacy initiatives to empower young adults living with chronic and rare conditions. Generation Patient was incorporated in 2018 by young adult patients. We aim to empower young people (16-35) living with chronic, rare, and undiagnosed conditions. In addition to providing direct support and resources to young adult patients, the organization actively works to make strides in the areas of higher education, health policy, and research to enhance the overall quality of life for individuals diagnosed with chronic conditions during their adolescent and young adult years, as well as for generations to come.

Generation Patient is not disease-specific, with young adult patients across numerous disease groups participating in its programming. We recommend you see the graphic below and read our annual report linked above!

Generation Patient Receives Grant from Responsible Technology Youth Power Fund

Generation Patient has received a grant from the Responsible Technology Youth Power Fund for our work to increase oversight of pharmaceutical direct-to-consumer advertising on social media.  

Beginning in July of 2022, our team expressed our concerns regarding the increasing prevalence of direct-to-consumer advertising by pharmaceutical companies on social media platforms such as TikTok and Instagram. As the regulation is outdated to newer platforms, we recognized the urgent need to address the potential consequences and implications of direct-to-consumer advertising for our demographic. Prescription medicines advertised on social media lack appropriate safety information and disclosures, making it difficult for young patients to make informed decisions about their health. The increasing use of influencers to advertise prescription medicines also poses a great concern for the negative impact on young patients.  

“As an organization led entirely by young adults with chronic medical conditions, we are eager to drive young adult-patient-led solutions with researchers, clinicians, and public interest groups,” said Sneha Dave, executive director at Generation Patient. “Misleading prescription drug and supplement advertisements pose an increasing challenge with the vast misinformation and disinformation, especially on TikTok and Instagram.”

This grant will enable us to proactively address this issue by collaborating with various representatives in the fields of technology and public health while advocating for improved and more effective standards in the regulation of direct-to-consumer advertising. We believe that direct education, resource sharing, and peer support are our most effective tools to create pathways for young adult patient empowerment. This award will allow us to continue this crucial work within the social media landscape.

Generation Patient is a U.S.-based and internationally connected non-profit organization created and led by young adults with chronic conditions. We are the largest organization representing adolescents and young adults with chronic conditions through our peer support initiatives, community building, and systems advocacy. Our independence is important to us, and we do not accept funding from the private healthcare industry and are supported by philanthropic foundations. 

Our comment on Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer

Generation Patient is the largest organization representing adolescents and young adults with chronic and rare conditions. We are led entirely by young adults with chronic conditions. We take no pharma funding. We work to increase the health literacy, confidence, self-management skills, and advocacy strategies of young adult patients.

Patient-centered patents 

NIH has a unique opportunity to support the issuance of only high quality patents by ensuring that its patents serve as valuable prior art. Your agency can set the stage for  comprehensive and thorough discussions of existing work in the field that can be cited to challenge other patents effectively. Instead of merely describing the patent claims, NIH should clearly elucidate the background and scope of the innovation you intend to safeguard for future advancements. In this same vein, NIH must create quality guidelines for NIH patents to set a standard that others should follow. This might include the number of claims, the broadness of claims, and the robustness of disclosures.

March-in rights 

When drug prices get out of control, we urge the NIH to use its march-in rights. The public dollars NIH expended for development of certain therapeutics should be returned for the public benefit, by making over-priced drugs more affordable through the use of march-in rights.  Additionally, today’s drug shortages are affecting our young-adult community; march-in rights provide a critical opportunity to allow for widespread manufacturing. 

Reasonable Pricing

The NIH should enforce reasonable-pricing claims. You must use your authority to ensure that publicly funded medical technology is priced fairly. Patients in the United States are struggling to afford medicines that have been at least partly available due to public investment. The American public deserves to benefit from reasonable pricing protections which will enable them to have access to such life-saving medicines. 

Conclusion

According to the CDC, over half of young adults in the United States have a chronic condition. This number is only growing. The NIH can help young, lifelong patients across the U.S. and internationally  afford therapeutics which help them improve their quality of life and allow them to thrive into adulthood and beyond. As a patient group, we do not believe innovation and affordability are mutually exclusive. The NIH has a responsibility to balance innovation with affordability and access.

Our comment to the United States Patent and Trademark Office: America Invents Act Trial Proceedings Before the Patent Trial and Appeal Board

Generation Patient was created—and is led entirely—by young adult patients. Through our nonpartisan work and focused initiatives—the Health Policy Lab and the Crohn’s and Colitis Young Adults Network —we increase the health literacy, confidence, self-management skills, public policy knowledge, and advocacy strategies of young adult patients. We have developed programming for navigating the higher education landscape and educating people about health policy with independent research and analysis. Additionally, we have facilitated more than four hundred virtual meetings and events during the past two years focused on connecting young adult patients worldwide and providing them with critical peer support. Our organization does not accept funding from the pharmaceutical, insurance, hospital, or related healthcare industries. 

The current proposed rules of USPTO about inter partes review and other post-grant review proceedings negatively affect us as young adult patients and the next generation of patients. These must be reconsidered due to the adverse consequences they would impose on patients and the greater public in seeking to contest invalid patents. By creating heightened barriers, these rules stifle competition and unjustifiably drive up prices, particularly for crucial medical treatments we rely on as patients. Moreover, inter partes review fosters innovation by ensuring that patents do not impede future research and development. When invalid patents are challenged, it paves the way for others to build upon existing knowledge and create new, innovative treatments. This promotes a more dynamic and competitive pharmaceutical industry, leading to the development of new medicines and improved healthcare options. 

When the patent system is misused, our demographic of young people with chronic conditions is disproportionately affected. We need novel innovation, fairly priced. As young people, we rely on affordable medicines and need prescription drug inventions with more than a marginal benefit. 

The USPTO should retract its proposal and, in its place, propose rules that actively foster the challenging of invalid patents, facilitating a more accessible process for the broader public to do so. This aligns not only with the original intentions of Congress but also addresses the pressing needs of the American people, who are counting on a fair and supportive patent system.

In conclusion, we want to emphasize that for us as young adult patients, access to affordable prescription medications is a basic human need. According to the Georgetown University McCourt School of Public Policy, 53% of people ages 18-34 use prescription drugs. Moreover, 21% of people ages 18-49 say they have difficulty affording their medication. The share is likely to be even higher for younger adults given that the highest poverty rate in the United States is between the ages of 18-24, but given that research does not sufficiently focus on young adult populations, there is no specific data to cite.

We welcome elaborating on any of the above and continuing to partner to ensure the patent system works for patients.

Sincerely, 

Generation Patient 

www.generationpatient.org 

My Experience Becoming ‘Officially’ Chronically Ill as a Young Adult

By Cade Johnson

I was sick as a child. Frequently, notably sick. A few days after my birth, my mother returned to the hospital because I wasn’t nursing. Within a year, I was back again, then for severe and recurrent ear infections–fortunately, treated in time with a myringotomy tube surgery to avoid permanent hearing loss. My mother, an artist with an MFA in photography and a lifelong personal tendency towards archiving, took plenty of photos even when I was in the hospital.

One photograph, in particular, stands out in my memory: a child, small even in a pediatric bed, wearing a tiny blue surgical cap, surrounded by nurses. This was the first of my medical troubles, but unfortunately–in a foregone conclusion, perhaps–far from the last. My extremities today have pale scars at the wrists and ankles, ghostly reminders of several bouts of impetigo. The weeping sores were difficult to differentiate from the broad swatches of itching, ruby-red and blistering hives that would also cover my skin. During childhood, I experienced migraines that ruined birthday sleepovers, frequent UTIs, and episodic diarrhea that kept me doubled over and dreading public restrooms. In high school, I was plagued with fainting and fatigue. After a few emergency room visits, I was diagnosed with a mitral valve prolapse which made participation in athletics unlikely–not least because of persistent clumsiness that resulted in broken bones, twisted ligaments, and battered flesh from unlikely accidents. 

But it wasn’t until well into adulthood that I was diagnosed with the chronic illnesses that follow, the names and symptomatologies that I use as shorthand for providers and friends alike. Irritable Bowel Syndrome (IBS), fibromyalgia, hypermobile type Ehlers-Danlos Syndrome (EDS): they give shape to my experience without needing an exhaustive account of the whole saga. Did I instantly become chronically ill the moment those words appeared on my chart? Simple logic says no, but reconciling my identity and autobiography with this “new” designation was still a startling shift. I felt like the revelations raised more questions than they gave answers, an experience that, as a historian-by-training, was both exciting and daunting. Here was a much larger question to be answered via research, documentation, and observation, rather like the archetypal detective–my personal tendency in dealing with challenges in life is to intellectualize. 

Yet being a young person with a chronic illness can feel like being stuck in a never-ending detective novel. Still, it’s not nearly as exciting to live in a mystery as it is to read one–the twists and turns, red herrings, and double-meanings are less thrilling and more exhausting when it’s not your entertainment or your academic pursuit and instead is your life. No one wants to be the last page torn out of the journal or the cryptic message left on the answering machine. 

That said, I have come to realize that it doesn’t have to be like that. With peer support, community building, awareness raising, provider collaboration, and policy change, being a young adult with a chronic condition can be, if not exactly easy or straightforward, at least not an endless series of riddles. I’m proud to be a part of Generation Patient and our mission to empower young adults with chronic illnesses not just to survive but to thrive. 

Ease of Access to Accommodation Information: Assessment and Commentary

Introduction

The ability to pursue and complete postsecondary education can greatly impact the future security, quality of life, and continued survival of individuals who are diagnosed with lifelong health conditions as children and young adults. However, whether or not these individuals may even attempt to pursue higher education often greatly depends on their ability to access accommodations and information regarding these support systems. In 2014, Liz Morasso worked with chronically ill teens and young adults as a clinical social worker at Children’s Hospital Los Angeles. Morasso wrote about the lack of support for disabled students with chronic medical conditions entering college, explaining that, “I regularly struggle to find information on services and eligibility criteria for the estimated 6% to 9% of high school students with a disability who are about to make the transition to college. Most disability offices clearly define eligibility for students with physical, sensory or learning disabilities and mental illness. But it’s far less clear how these services and resources pertain to students with chronic illness, especially illnesses that manifest themselves episodically or invisibly.” Nine years later, young adults with chronic medical conditions continue to report these same issues. 

Access to and the implementation of appropriate accommodations are crucial pieces of the college experience for students with chronic medical conditions. Given that communication with university Disability Offices is typically the first step required for students to access these accommodations, we aimed to assess the ease of access to information regarding accommodations via phone calls to the Disability Offices of community colleges, state-funded universities, and private institutions of higher education in California. 

Purpose & Methods

This study was designed by the leadership team at Generation Patient (AKB, SD, and SR), a nonprofit created and led by young adults living with chronic and rare medical conditions. Generation Patient facilitates events, online programs, and advocacy initiatives for this community, with the goal of ensuring that they have the opportunities and resources to thrive. Our study was informed by our own personal experiences accessing accommodations, as well as the experiences of other members within the Generation Patient community. Specifically, we sought to analyze the common themes between various Disability Offices as it pertains to disability documentation processes, accommodations offered, procedures for absenteeism, and dining accommodations. Moreover, since Disability Office staff are likely to be the first individuals on campus to speak with students about their chronic medical conditions, we aimed to understand Office faculty’s knowledge of accommodations specific to chronic medical conditions as well as the language surrounding this.

A total of 29 phone calls were made, including 13 to private universities, 7 to two-year community colleges, and 9 to four-year public institutions (including 6 California State University and 3 University of California campuses). Using stratified random sampling and a random number generator, we selected schools from segmented lists of private universities, community colleges, California State Universities, and University of California campuses. Pre-determined a priori themes were utilized in the creation of the interview guide with input from AKB, SD, and SR (e.g. accommodation types, registering for accommodations, and attendance/absenteeism). 

In order to maintain anonymity and realism, the phone call script was written from the perspective of a prospective student who was diagnosed with a chronic medical condition and thus was interested to learn more about the accommodations offered at that particular institution. AKB conducted four initial pilot phone calls, after which AKB, SD, and SR used an iterative process to adjust questions and phone call foci. We alternated the medical condition that we were calling about, between Crohn’s Disease or Postural Orthostatic Tachycardia Syndrome (POTS). All calls were made on weekday afternoons by AKB. The full script can be found in Appendix 1.

Results: Qualifying for Accommodations

Many students with chronic medical conditions may not recognize that their diagnosis would qualify them to register with their school’s Disability Office and receive accommodations under the Americans with Disabilities Act and Section 504 of the Rehabilitation Act. Thus, in order to assess Disability Office staff’s familiarity with the applicability of accommodations for chronic medical conditions, staff were asked, “I am a prospective student, and I am calling to hopefully get some information about the accommodations at your institution. I have [POTS or Crohn’s]. I was wondering whether that would qualify me to register with your office?” 

We were met with a variety of responses, ranging from prompt assurances that chronic conditions qualify for accommodations to long pauses followed by a blunt, “What’s that?” Despite the different replies and response times, all offices did eventually confirm that the condition we were calling about (either Crohn’s disease or POTS) did qualify for accommodations. Since the Disability Office is often the first place that students may turn to when seeking appropriate accommodations, it is of the utmost importance that students are met with understanding, support, and knowledge in order to feel empowered to pursue the support services that they need and deserve in order to be successful. If met with hesitancy or doubt upon asking if their medical condition qualifies, the false notions that these students do not belong or aren’t “disabled enough” may unintentionally continue to be perpetuated. This is especially true with cases of dynamic or invisible disabilities.

Given this, we recommend that Disability Office staff, particularly those responsible for answering the phones and engaging in a “front-facing” role with students, build more familiarity with chronic medical conditions. Specifically, it would be helpful to explicitly name and give examples of different chronic medical conditions both on the Disability Office website as well as during staff training. Staff members should also be trained on appropriate language use and tone of voice, so that students are met with respectful assurance of their eligibility for accommodations.

Documentation of Disability

The disability documentation process has previously been identified as a challenge by our community, particularly for young adults with rare diseases and for those whose intersecting identities may contribute to underdiagnosis and lack of access to care. For this reason, we aimed to understand the registration process for accommodations at various schools, including the whether there are particular forms and documentation students need to complete and if there is a specific type of clinician required to complete this documentation depending on the student’s disability.

While some institutions required a letter from a clinician, others had a specific form for the clinician to fill out (which was generally found on the Office’s website). When asked about whether this documentation had to come from a specific type of health care professional (primary care versus specialty), most Offices indicated that as long as the clinician was aware of the impact of the health condition on the student’s “functional limitations,” their area of practice did not matter. 

These policies can be helpful for individuals who have access to appropriate, specific care. However, it would be remiss not to recognize the limitations surrounding the disability documentation process, including the ways in which classism, sexism, and racism can prevent or greatly prolong the diagnosis of chronic medical conditions. This is particularly compounded by the fact that for students in higher education, the responsibility to seek a diagnosis rests squarely on their shoulders, instead of within the school system itself (as is the case for K-12). Thus, it is important for Disability Offices to receive education related to the limitations in the documentation processes, so that they can better help students navigate this process, particularly those who are undiagnosed but needing accommodations. This can include a more clearly-defined guide about how to obtain this documentation, including providing resources for seeking care at the school’s health center or local clinics.

Types of Accommodations Offered

Next, we aimed to understand the types of accommodations that are most commonly offered and available to students with chronic health conditions, by asking “Would you be able to give me an overview of the types of accommodations that are offered to students like me?” The most frequently mentioned accommodation offered was notetaking support, though the mode of this accommodation (via volunteer/classmates, directly from the professor, etc.) varied between institutions. Some of the other less-frequently mentioned accommodations (in response to this question) included flexible attendance, flexible assignment deadlines, and housing accommodations. 

One common theme emphasized during most phone calls was the importance of meeting with a Disability Support Counselor (or equivalent staff member) after disability documentation has been obtained, for this Counselor to work individually with the student to assess their needs. Some individuals did indicate that they would not be able to provide specific examples of accommodations since they were unsure of what specific accommodations may be helpful for a student with conditions such as Crohn’s or POTS.

Though we recognize that accommodations are individual, and thus should be customized depending on the specific needs of each student and the way they experience their health condition, we simultaneously recommend that Disability Offices have tangible examples to provide students that can illustrate the types of accommodation that are offered and may be useful to them. These examples can be particularly helpful and reassuring to students who are newly diagnosed and/or are new to receiving accommodations.

Chronic Absenteeism 

Chronic medical conditions are often characterized as “dynamic disabilities” due to their fluctuating nature. This can lead to students experiencing unexpected symptoms and cause them to have variable attendance, which in some cases can lead to chronic absenteeism. To better understand each school’s ability to support students in these situations, we asked, “My disease can be kind of unpredictable sometimes, and I don’t always know if I’ll feel well enough to get to class… What support would you be able to provide me in this case?”

Most Offices indicated that how stringent an attendance policy is and whether a lecture is recorded is largely dependent upon each individual professor. So, while Offices did indicate that flexible attendance could be part of a student’s accommodations, many did emphasize that this can be highly variable. Especially in these situations, it is important for the Disability Office to emphasize and affirm to students that they can help be a liaison for their professors in these situations. There is a pervasive lack of understanding about the experiences of students with chronic medical conditions, and this can translate into attendance and recording policies that may not be in the best interest of these students. Given this, it can be helpful for the Disability Office to explicitly offer support for students by helping directly facilitate a conversation with their professors. 

Moreover, given that the COVID-19 pandemic has allowed universities to expand their infrastructure and abilities to provide online classes, we recommend that institutions implement system-wide changes to provide lecture recordings for more classes. This includes not only encouraging or requiring professors to record their lectures, but also providing the tools and equipment in order to do so.

Dietary Concerns

Dietary restrictions were not something that the Offices mentioned as part of their general accommodations, so we also asked about how various dietary needs were addressed. Beyond mentioning that there are gluten-free options (generally, a gluten-free pantry or meal options) available, the majority of the Offices indicated that they were less familiar with these accommodations and that they recommended the student go through Dining Services directly to address any dietary concerns. 

While we do understand that Dining Services operates separately from the Disability Office, part of the Disability Office’s commitment to students is to advocate for their students, including helping navigate conversations between various entities at the institution. In order to facilitate this and to ensure that students with dietary needs are accommodated appropriately, Disability Offices should have a specific liaison or communication process between themselves and Dining Services. This would alleviate the burden placed on students to reach out to separate organizations within their institution, in order to have their access needs met.

Role of Disability Support Staff

Finally, to wrap up the calls, we asked what the person’s role was at the Disability Office. While some Disability Counselors did answer the call, the majority of calls were answered by an administrative assistant, scheduler, or other equivalent. Particularly at the smaller, private institutions, the person answering the phone did not exclusively work within Disability Services, but rather was part of a more general, multi-disciplinary student affairs team. It is to be noted that in some cases, the phone went straight to voicemail. Some recorded voicemail mailbox greetings indicated that email was the best way to reach out to their Office, while others indicated that they did not have a live answering service, but someone would call back if a voicemail is left. 

Given this, along with the fact that not all schools had a designated/separate office, person, or phone number to call in order to discuss accommodations, it may be more efficient for students to first reach out via email, to ensure that their questions are directed to the appropriate people who can help. That being said, we recognize that phone calls can appear to be the quickest way to receive answers or get some preliminary information. Given this, we believe that it would be helpful for all front-facing staff members to be trained not only on the specific resources that are offered to students, but also on appropriate and compassionate tone and language use.

We also recommend that Disability Offices make it clear on their websites (and other informational materials) whom the appropriate person is to contact and through which method (such as email, phone, an online form, etc.). This would make the information and registration processes more efficient for both students and staff.

Conclusions and Key Recommendations

In summary, given the crucial role of accommodations in ensuring the success of students with chronic medical conditions in higher education, we recommend that the following steps be taken and considered by Disability Office leadership and staff. 

  • First, Disability Offices should provide easy access to clear information regarding disability services, accommodations, and related processes, as well as appropriate and reliable contact information on the university website is essential. We would suggest 

  • including examples of chronic medical conditions for students who may not realize that their condition qualifies them to receive support services through the Disability Office. 

  • It is also critical that any Disability Office staff that may be interacting with prospective or incoming students be educated on chronic medical conditions, appropriate language use, and demeanor. 

  • Furthermore, proper training and education on the needs of students with chronic medical disabilities should extend to all university staff to create a truly accessible and supportive learning environment across campus. More specifically, providing faculty with a better understanding of the unreliable nature of such conditions (particularly dynamic and unapparent conditions) and challenges that result such as chronic absenteeism, as well as needs for flexible education options, reduced course loads, and beyond. This information may help to encourage faculty and administrators to implement policies and behaviors that will allow for creative solutions to the unique problems currently faced by these students. 

  • Finally, we would encourage college disability offices and advisors to act proactively as advocates on behalf of students with chronic medical conditions by working as communication liaisons between students and any areas of the university that plays a role in their accommodations including but not limited to professors, department heads, dining services, health services, and more.

Currently, young adults with chronic illness face unique challenges within institutions of higher education, which impacts their ability to attain both educational and career opportunities and, by extension, their future independence and quality of life. By working to implement changes like those outlined above, universities can make secondary education more accessible to individuals living with chronic medical conditions before they are even officially enrolled and ensure their students are equipped with the necessary support to complete their educational goals.

Letter to the USPTO and FDA 

Re: Docket No. PTO-P-2022-0037 

Director Vidal and Commissioner Califf: 

The undersigned organizations are submitting additional comments to add to the record, after several of us participated in the USPTO-FDA Listening session on January 19, 2023. One common theme among the patient, consumer, and disability advocates was the need to improve opportunities for those most impacted, patients and consumers, to be included within the USPTO and FDA collaboration. As patient, consumer, and disability organizations, we urge the USPTO and FDA to better include the American public in any discussions for patent examination and approval reforms. Together, we must ensure that the patent system works for patients and the public and that evidence drives all decisions at the USPTO and FDA. We see a great opportunity for the USPTO and FDA to lead in early patient engagement best practices. 

In the past, patients have been effectively excluded from key discussions on patent reform, often thought to be too technical. The recent comment made by PhRMA states that “patient groups and other stakeholders interested in participating in the patent prosecution process can use existing mechanisms to submit printed publications that are relevant to the examination.” We disagree, the current mechanisms are extremely difficult for the general public to engage in processes such as third-party art searches and more. Many patient groups do not know that public feedback mechanisms exist so there must be more public awareness and dissemination. Existing mechanisms and the status quo are not working for those who are not in the business of creating and patenting pharmaceuticals and medical devices and we want that to change. The USPTO currently makes extensive efforts to help small inventors engage with and understand the patent system, and similar outreach could be extended to patient communities. 

And for the few of us who have found ways to participate in the formal regulatory processes, it is unclear on the follow-up of feedback from patient groups. Moreover, patent examiners are unlikely to give prior art submissions from third parties substantial consideration, but they may still cite those submissions on patents when they issue. That is a problem because district courts are less likely to invalidate and the Patent and Trial Appeal Board is less likely to review patents based on cited prior art. As a result, submitting strong prior art during examination is more likely to prevent than ensure its consideration. As patients, and consumers, we feel a deep urgency to introduce novel, meaningful patient engagement opportunities within this collaboration. Furthermore, opportunities for patient engagement should be accessible, including providing opportunities for virtual participation.

We also wish to note the importance of hearing from patient groups that are independent of industry funding or have displayed a clear firewall between industry funding. We have noted the silence of many patient groups when it comes to pharmaceutical policy, notably because of the significant financial support these groups receive from the pharmaceutical industry. To evaluate and provide unbiased decisions to the USPTO and FDA, patients or patient groups must be required to prove industry independence. 

The USPTO should ensure that patient engagement opportunities allow for true input and patient involvement should be respected and considered. Equitable representation of patients should be of paramount importance. There are several core principles of ethical engagement, highlighted by T1International, including compensation, diversity of voice, and patient-led strategies. Some notable questions they include are: 

  1. Are you compensating patients as experts?

  2. Have patients been involved in planning, leadership, and creating the overall strategy? 

  3. Have you informed patients of the purpose behind their participation? 

  4. Is there a clear plan for how patient contributions will inform any work moving forward? 

An example that could be referenced as a strong model for engaging patients is the Institute for Clinical and Economic Review. Within this model, patient advocates are part of the voting councils and are allowed to vote as other healthcare professionals. Patient advocates on the voting council receive the same payment and are given the same opportunities to speak and ultimately evaluate the evidence from a patient-centric perspective for all appraisals.

In order to better incorporate patient voices in the patenting process, we suggest the creation of a pharmaceutical-specific art unit, as suggested by Professor S. Sean Tu. Applicants should be required to ex ante disclose applications that could be listed in the Orange Book or Purple Book for examination in a specialized art unit. This would allow patient advocates to voice their opinions on those patents that would affect their specific indications. Currently, it is difficult to determine which patent applications are relevant. We note that this should not be difficult to implement since the smallest molecule Orange Book patents originate from two art units in Workgroup 1610 and most biologics originates from two art units in Workgroup 1640.  

The patient voice must be genuinely and meaningfully incorporated early relating to the implementation of this collaboration. We look forward to partnering and working closely with both agencies in ensuring that the American public is prioritized. 

Sincerely, 

Asian Americans with Disabilities Initiative

Chronic Illness Advocacy & Awareness Group

Consumer Action

Connecticut Health Policy Project 

Connecting to Cure Crohn's and Colitis 

Crohn's and Colitis Young Adults Network 

Disability Rights California

Doctors for America

e-Patient Dave, LLC

Fight Like A Warrior 

Generation Patient 

Health Care Voices

IBDMoms 

Initiative for Medicines, Access, and Knowledge

Islamic Civic Engagement Project 

National Alliance of Multicultural Disability Advocates 

Oregonizers

Patient Safety Action Network

People With Empathy 

Propel a Cure

Sumaira Foundation 

T1International 

The Light Collective 

Tigerlilly Foundation

Universities Allied for Essential Medicines

USA Patient Network

U.S. PIRG (Public Interest Research Group)

Job Posting!

Title: Administrative and Program Assistant 

Classification: Full-time (40 hours per week) or Part Time (20 hours per week) available. Note that we prefer full-time applicants. 

Location: Remote, US-based

Salary: The annual base salary range for this position is approximately $40,000 - $55,000 full-time. The salary offered will be determined according to a salary scale that takes into account years of experience, location, job category, and other factors.

Benefits: Paid leave on all bank holidays observed by the Federal Reserve System. Flexible hours. Remote work. Position may be eligible for additional employee benefits as to be determined by Generation Patient.  

About the role

The role of the Administrative and Program Assistant is to support in managing internal and external communications across Generation Patient’s portfolios. This is a new role with a small team. It is important to note that all of the programs and duties do not happen simultaneously but seasonally. 

This role will report to the executive director. Generation Patient is a remote office environment so you should be able to work from home. 

Responsibilities

Program Management - 50%

  • Manage the Crohn’s and Colitis Young Adults Network Fellowship 

    • Editing and updating monthly CCYAN Fellow content 

    • Coordinating and leading monthly fellow speaker meetings

    • Primary communicator for the IBD Medical student scholars  

  • Prepare logistics for the Roundtable on Young Adults with IBD Meeting  

  • Coordinate meetings for health policy scholars 

  • Coordinating six peer support meetings per month, including evaluation tracking.  

Communications - 25%

  • Organize speaker communications and outreach partners for the virtual Summit 

  • Oversee donor communications and updates by email, virtual meeting, and more to increase support 

  • Create presentations as needed, such as for the board meetings

  • Support with team Communications, including events and writing newsletters

Project Management and Admin - 25%

  • Project Manage the implementation of Salesforce for Fundraising, working with the Operations Manager and Development Coordinator to ensure that the platform meets the Development team's needs, entering data, and pulling reports and stats

  • Maintain documentation about grant reports and timelines 

  • Lead on annual impact report content drafting, document design, and final report distribution

  • Other duties, as assigned

Qualifications

  • Ability to thrive with little direction in a startup nonprofit environment

  • Preferable to have experience in public health, health policy and working with small teams

  • Preferable to have lived experience with chronic disease or illness

  • Preliminary knowledge of health policy, a strong understanding of intersectional social justice issues. 

  • Willingness to support other aspects of Generation Patient 

  • Comfortable moving between big-picture concepts and fine details to both strategically plan and execute work to a high standard

  • Strong communication and collaboration skills, including writing and editing

  • Familiarity and experience with a range of communications tools and approaches (Canva, Mailchimp, Action Network, Gmail Templates, etc.)

  • Excellent organizational and administrative skills and keen attention to detail, especially while managing multiple projects and deadlines

  • Ability to prioritise and work independently to deadlines and goals

  • Strong critical thinking skills and problem-solving ability with good, independent judgment

  • Able to work efficiently and independently as well as collaborate effectively with others; we are looking for someone who can follow set processes to take work forward - someone with a ‘let’s make this work attitude who is willing to ask for help when needed

  • Flexibility to change role duties as needed 

  • Excels with online tools including Google Workspace, social media, and database programs

  • English fluency 

  • Excitement to work with a team of young adult patients 

About Generation Patient

Generation Patient is a nonprofit organization empowering adolescents and young adults with chronic conditions. As an entirely young adult patient-led organization, we focus on areas of peer support, higher education, health policy, and more. Programs through Generation Patient include the Crohn’s and Colitis Young Adults Network and the Health Policy Lab. Furthermore, we are fully independent of healthcare industry funding, ensuring the integrity of our work and perspectives. 

To apply

Please submit to virtual@healthadvocacysummit.org:

  1. CV (3 pages max)

  2. Cover Letter addressing qualifications (2 pages max)

  3. Three references, including name, position, and contact information. 

Incomplete applications will not be considered.

Process

Applications will be reviewed on a rolling basis, and only shortlisted candidates will be contacted. For your application to be considered in the first review, please submit it by February 10, 2023. 

The application process will include at least two Zoom interviews and potentially more written materials. 

We encourage young adults with chronic medical disabilities to apply. We are an equal-opportunity employer. 

Generation Patient’s USPTO/FDA Comment

Dear Commissioner Califf and Director Vidal: 

Generation Patient was created—and is led entirely—by young adult patients. Through our nonpartisan work and focused initiatives—the Health Policy Lab and the Crohn’s and Colitis Young Adults Network —we work to increase the health literacy, confidence, self-management skills, public policy knowledge, and advocacy strategies of young adult patients. We have developed programming related to navigating the higher education landscape as well as educating people about health policy with independent research and analysis. Additionally, we have facilitated more than four hundred virtual meetings and events during the past two years focused on connecting young adult patients around the world and providing them with critical peer support. Our organization does not accept funding from the pharmaceutical, insurance, hospital, or related healthcare industries. 

Through our only disease-specific program, the Crohn’s and Colitis Young Adults Network (CCYAN), we work to empower adolescents and young adults with inflammatory bowel diseases. Humira, a medication needed by many in our CCYAN community, has been granted 166 patents and has delayed biosimilar entry until 2023 in the U.S. This is just one of many examples which illuminates the need for the USPTO-FDA Collaboration. 

We appreciate this opportunity to address the USPTO and FDA Public Listening Session. The following points are divided into sections based on what we feel is most critical to address. 

Engage patient stakeholders 

Patient stakeholders are critical but are often underrepresented as equal stakeholders in policy and regulatory discussions. The USPTO and FDA must have accountability to those most impacted, patients, in all aspects of the collaboration. We recommend the development of an independent public advisory committee, inclusive of patients who represent areas from chronic to rare diseases, different age groups, and more. This independent public advisory committee could play a critical role in advising on public dissemination of information, best practices for engaging the public and patient stakeholders, and ways in which this collaboration could be even more patient-centered. We commend that the FDA already has a variety of existing patient engagement opportunities. Rather than just having patients serve on separate patient councils, we encourage the integration of patients in all core activities of this collaboration. We also wish to encourage the foremost engagement of individuals and organizations that are independent of pharmaceutical industry funding. Further, as part of an advisory council, we uphold that patients must be compensated for their time and experience to ensure that there is an equitable representation of who can provide this insight. 

Value-based patents 

Before a patent extension is granted, it is important to understand what benefit the drug actually has on patients. Does a secondary patent meaningfully increase the clinical benefit and pose a transformative impact on patient quality of life? We have to acknowledge the misuse of patents to extend market exclusivity through evergreening. Modifying a drug without a meaningful impact on the utility proves unnecessary in improving patient lives. Should it warrant a new patent that allows drug manufacturers to continue escalating the cost of lifesaving drugs for patients? As patients, we need novel medications, not the ones we have already tried and which have not worked for us. When we reward pharmaceutical companies with new patents on old drugs, we remove the financial incentive to do the hard work to find truly novel treatments and cures.

FDA and USPTO should establish channels for sharing information about an applicant

Patent examiners should have access to a wider array of information when conducting prior art searches, including updated information from the Orange and Purple Books, FDA decisions, and scientific information. We also recommend that when considering secondary patents, sponsors can be better held accountable to share robust evidence, diversity in clinical trials, and adequate documentation of safety data earlier on. 

This a unique opportunity to advocate for children, adolescents, and young adult patient populations 

Through this collaboration, we believe there is an opportunity to place an emphasis on pediatric, adolescent, and young adult populations, patient populations that have historically been left behind within clinical research. We encourage novel ways of thinking to incentivize pharmaceutical companies to truly innovate to develop drugs for pediatric populations.

Further, there must be better incentives for evidence generation earlier rather than nearing the end of an initially granted patent. A study showed that approximately 1 in 10 pediatric trials ended early and that the results of the majority of these had not been published even three years later. We feel that the incentive is low for actually completing pediatric studies, rather it feels like there is a simple “encouragement” of earlier pediatric research, without actual timely completion. We suggest a sense of urgency for creating a collaborative system in which there is a true incentive to bring pediatric-approved therapeutics to market, rather than creating opportunities to delay generic/biosimilar competition.  

We also wish to note that when the patent system is misused and when me-too drugs are created, our demographic of young people with chronic conditions is disproportionately affected. We run out of treatment options quickly and we have a lifetime ahead of us. We need novel innovation, fairly priced. 

Over 85% of young people with chronic conditions are now surviving into adulthood, many of whom live with complex, lifelong conditions. For us as young adult patients, access to prescription medications is a basic human need. According to the Georgetown University McCourt School of Public Policy, 53% of people ages 18-34 use prescription drugs. Moreover, 21% of people ages 18-49 years old say they have difficulty affording their medication. The share is likely to be even higher for younger adults given that the highest poverty rate in the United States is between the ages of 18-24, but given that research does not sufficiently focus on young adult populations, there is no specific data to cite. This collaboration is a unique opportunity to ensure the adequate representation of young adult patients within actions to make medications more affordable. 

We welcome elaborating on any of the above and continuing to partner with USPTO and FDA to include patients at the forefront of all actions taken through this important collaboration. 

Sincerely,

The Generation Patient Team

Access the PDF version of our comment here.

New resource guide for young adults with chronic conditions transitioning from pediatric to adult care

Click here to see our new resource guide: Transitioning from Pediatric to Adult Care (While Transitioning to College)!

This resource guide discusses the transition from pediatric to adult care and is primarily focused on young adults who are making this transition while also transitioning to college, as these events often occur simultaneously. However, please note that everyone’s disease journey is different, and it’s best to speak directly with your current physician and clinical care team to determine if and when would be the appropriate time to transition from pediatric to adult care. 

Our guide provides tips on…

  • Switching providers while moving to college and seeking out a new clinician

  • Items to complete and consider before your first visit

  • Adjusting to a new clinical care team

  • Registering to receive accommodations on your college campus along with examples of helpful accommodations you may be able to receive


For questions, comments, or to suggest/request any other resources, please contact Generation Patient’s Higher Education Coordinator, Amy Bugwadia, at amy@healthadvocacysummit.org. 

Part Two: Things Young Adult Patients Wish Medical Professionals Better Understood

#7: Even when our parents are with us at an appointment we should still be the one being addressed/spoken directly to. We are the patient, it is our health.

#8: It can be hard for us to trust a new physician at first. Building the patient-provider relationship is key.

 

#9: It is okay to admit you don’t know everything about our condition(s). We respect honesty over uninformed treatment.

#10: We would like to understand all of our treatment options, rather than only getting an explanation of the one you were recommending.

#11: Asking questions can feel intimidating. Leaving allotted time for addressing our concerns is very helpful.

#12: We know you cannot fully understand our experience with our illness, but a little empathy goes a long way.

Part One: Things Young Adult Patients Wish Medical Professionals Better Understood

#1: What works for one patient doesn’t always work for another, even if they have the same symptoms/illness.

"…the one size fits all approach shouldn't apply to all aspects of patient care. While efficiency is important, the practice of algorithmic medicine doesn't necessarily lead to better outcomes. In fact, it can lead to missed symptoms, misdiagnoses, and unnecessary tests…when facing patients, it's best to focus on their individual symptoms instead of lumping them into a category."

Source: https://www.carecloud.com/continuum/standardized-care-does-one-size-fit-all-in-medicine/

#2: Just because we are young does not mean we cannot have a serious illness.

"Unlike older patients, younger patients more often experience undertreatment due to their age. Young people 'aren't supposed to' get certain diseases, according to medical books and statistics, but they do — time and time again. Because of this, inappropriate assumptions are made, and they're often dismissed."

Source: https://intivahealth.com/blog/the-rising-problem-of-ageism-in-healthcare/

#3: Mental and physical illness can coexist. They are not mutually exclusive.

#4: When a provider rushes through an appointment, we often feel like we are not cared about and/or our concerns are not being adequately heard.

 

#5: We may be your patient, but first and foremost we are human. When we are treated in a cold and clinical nature it can often feel apathetic.

#6: We want to feel like you’re working with us on a treatment plan, rather than just being told what and what not to do.

Check out our forum on the fundamentals of health economics!

On October 18th, our (Health) Policy Lab hosted the first forum of a three-part series on health economics! This series focuses on the intersections of health economics and the impact of policy decisions on prescription drug pricing and is made possible with support from the Kazanjian Economics Foundation.

Check out Forum 1: Fundamentals of Health Economics featuring Benjamin Rome, M.D., MPH, instructor of medicine at Harvard Medical School.

Don’t forget to register for Forum 2: Applications of Health Economics here!

And check out this video to see how you can earn a Health Economics Certificate!

Resources for young adult patients from our Virtual Health Advocacy Summit!

Dysautonomia:

  • What is POTS

https://www.hopkinsmedicine.org/health/conditions-and-diseases/postural-orthostatic-tachycardia-syndrome-pots

  • Dr. Pace/Metrodora Institute

https://www.metrodora.co/

  • Dysautonomia International

https://dysautonomiainternational.org/

  • Facebook Support Groups

https://dysautonomiainternational.org/page.php?ID=24

  • Dysautonomia Clinic/Dr. Blitshteyn

https://www.dysautonomiaclinic.com/

Art Workshop:

Medical Trauma and Growth:

  • Dr. Amanda Feinstein - Yoga on YouTube

https://www.youtube.com/channel/UCUmfgP-b0hK7-SsS0N2oAxw

  • Better Sleep App

https://www.bettersleep.com/

  • National Alliance on Mental Illness (NAMI)

https://www.nami.org/Home

  • National Suicide & Crisis LifeLine: Call or text 988 or chat

988lifeline.org

  • American Psychology Association

https://www.apa.org/topics/mental-health/help-emotional-crisis

  • SAMHSA’s National Helpline

https://www.samhsa.gov/find-help/national-helpline

Free, confidential, 24/7, 365-day-a-year treatment referral and information service (in English and Spanish) for individuals and families facing a mental health crisis. 1-800-662-HELP (4357) or TTY: 1-800-487-4889

  • Crisis Text Hotline: Text “HELLO” to 741741

Available 24 hours a day, seven days a week throughout the U.S. Serves anyone, in any type of crisis, connecting them with a crisis counselor who can provide support and information.

Grassroots Activism:

  • Asian Americans with Disabilities Initiative

https://www.aadinitiative.org/

  • Health Justice Commons

https://www.healthjusticecommons.org/

  • MAD - Mutual Aid Diabetes

https://mutualaiddiabetes.com/

Decolonizing Patient Advocacy:

  • Chronic Pain India

https://chronicpainindia.com/

  • Africa Sickle Cell Organization

https://africasicklecell.org/

  • Crohn's & Colitis Ethiopia

https://ibdeth.org/

Diagnosed: Grief, Identity, Acceptance:

  • Crohn’s and Colitis Young Adult Network

https://www.ccyanetwork.org/

  • Generation Patient Virtual Community Meetings

https://generationpatient.org/virtual-meetings




Neurodivergence Resources:

  • AASPIRE Healthcare Toolkit

https://www.rwjbh.org/documents/csh/AASPIRE-Healthcare-tool-kit.pdf

  • Autistic Self Advocacy Network (ASAN)

https://autisticadvocacy.org/

https://morenikego.com/projects/

https://aaspire.org/

Global Access to Medicines:

  • Universities Allied for Essential Medicines

https://www.uaem.org/

  • Generation Patient’s (Health) Policy Lab

https://www.hplab.org/



Higher education resources from Generation Patient:

  • Accommodations 101/Overview

https://docs.google.com/document/d/1HM0BgrNEq8aOS7VasV6hpALcquv4BaELTTVfgRxlRNo/edit

  • Accommodations Letter Template from Your Doctor/Clinician

https://docs.google.com/document/d/1ffxzmr60rnyXpG08ngTrLKhL3vucRASc0fGhsnGdWvA/edit

  • Proceedings: Roundtable on Higher Education and Chronic Medical Disabilities

https://static1.squarespace.com/static/5c11eb6ab40b9daef16158a9/t/627b11e9737ecf2abbc4bf81/1652232690402/Roundtable+Proceedings.pdf

Movement and Mindfulness:

  • Noa Porten’s class schedule and newsletter

https://mailchi.mp/376135183f7c/noa




Closing Session with Selma Blair and Troy Nankin:

  • You can watch the documentary Introducing, Selma Blair on Amazon Prime and Discovery+

  • See Selma on Dancing With the Stars, all-new episodes Mondays at 8p ET/5p PT on Disney+

  • You can also check out Selma’s memoir Mean Baby: A Memoir of Growing Up which is also available on Amazon