Rare disease treatment is characterized by its numerous challenges, stemming from an overall lack of awareness across the healthcare landscape. This issue becomes a waterfall, trickling down and affecting crucial nodes of the healthcare value chain, such as regulations, existing healthcare infrastructure, and affordability, before it can even potentially reach patients. Hence, the cooperation of the public and private sectors with a firm basis in knowledge sharing and education is required to alleviate these multifaceted challenges brought from a lack of awareness.

The Root of Awareness  

Rare diseases are defined by their generally low population impact, with many markets agreeing to a ratioed figure, such as one patient per every 2,000 in a population. The rarity of such diseases results in a lack of awareness among both the general public and the healthcare practitioner community. This awareness gap translates into a significant challenge in patients receiving an accurate diagnosis. Combined with the relatively few specialized medical personnel for such diseases, this can lead to misdiagnosis or delayed referrals, resulting in an average time to receive a final diagnosis of up to 5 years. By this time, some rare diseases can cause significant distress, such as Leber hereditary optic neuropathy (LHON), which can cause vision loss in a matter of months if left untreated.

Patients face a journey of medical uncertainty, fiscal difficulties, and personal challenges. These issues are often exacerbated by healthcare systems that struggle to accurately and promptly diagnose such rare conditions.

Point-to-Point Hurdles in Medication Access

Across markets, the rare disease medication issue also has to contend with more tangible and operational concerns stemming from the lack of awareness. From a regulatory standpoint, the lack of rare disease understanding can lead to regulations being under equipped to address medication access. This is doubly so for more challenging regulatory landscapes, such as across APAC’s complex and fragmented market environment, where general healthcare accessibility can already prove to be a hurdle due to a combination of socioeconomic and geopolitical factors. This can lead rare diseases and their medications to be an underserved area, while more widely common health concerns are prioritized.

A key driver of healthcare access is the underlying infrastructure powering the supply chain, ensuring the distribution of medication to patients. Similar to regulations, supply chain systems can vary vastly in complexity, particularly when across challenging geography and when specialised logistics, such as cold chain solutions, are needed to handle sensitive medication. These can culminate in much-needed investment into supply chain infrastructure. For example, in APAC markets, such as Thailand, DKSH has established a network of satellite distribution centers that can provide last-mile delivery of sensitive medications to underserved areas in a short period of time.

Regulatory complexities and supply chain infrastructure aside, the barrier to rare disease medication accessibility most often felt by patients is the affordability of treatments. The high cost of rare disease treatment options is critical, with some reaching over a million dollars for annual or one-time treatment. The issue of cost is more amplified in regions like APAC, where many markets have less robust public health insurance or social support systems, placing a financial strain on patients, even when access is just within reach.

This collection of barriers to accessing rare disease medications can be daunting from the outset. As a challenge of global concern, addressing it requires a unified approach that combines in-market and industry expertise, all in service of bringing medication to underserved patients.

The Power of Collaboration

The unique challenges of rare diseases are too great for any single entity to tackle alone. Bridging this gap through collaboration is paving the way forward, with public-private partnerships (PPPs) emerging as a core means for success. These partnerships bring together government agencies, pharmaceutical companies, academic institutions, and patient advocacy groups to share expertise, resources, and risk. For instance, in the APAC region, initiatives like the APEC Action Plan on Rare Diseases have provided a framework for member economies to accelerate efforts in this area, including the promotion of multisectoral collaborations. Regional alliances, such as the Asia Pacific Alliance for Rare Disease Organizations (APARDO), have done valuable work in collaborating with advocacy groups to raise awareness about these conditions. On an organizational level, there are also healthcare partners, such as DKSH, who work with firms, such as Kyowa Kirin, to bring rare disease medications to markets by utilizing in-market and regulatory expertise. Moreover, DKSH’s local teams have strong market knowledge, enabling them to offer clients and customers expert advice on local regulation.

This collaborative approach is crucial for streamlining the regulatory process for rare disease medications, also known as orphan drugs. Governments, including many in Asia, have introduced specific regulations and incentives to encourage the development of rare disease medication. These include Orphan Drug Designations (ODD) that provide much-needed support, such as tax credits for clinical research. Beyond these incentives, regulatory bodies are considering a greater reliance on evidence from expanded access programs. This allows for the use of data from a smaller patient pool, which is often the only available source of information for such rare conditions, thereby accelerating the review and approval process.

From a patient perspective, financial aid is of vital importance and an area where collaboration is key. The high cost of treatments for rare diseases necessitates innovative funding models beyond traditional public insurance. One effective model gaining traction in APAC is the establishment of dedicated funds, supported by a combination of public and private contributions. Singapore’s Rare Disease Fund (RDF) is a prime example, where community donations are matched by the government at a significant ratio. This model provides long-term financial support for patients, while encouraging a sense of shared responsibility across society. Similarly, patient access schemes and managed access programs are being implemented to ensure affordability and controlled access to therapies before full reimbursement is in place. These schemes can be tailored to individual patient needs and help bridge the gap between regulatory approval and widespread access.

Ultimately, the future of rare disease medication accessibility rests on a unified, multi-stakeholder ecosystem. By building on collaborative frameworks, optimizing regulatory pathways, and pioneering innovative funding mechanisms, the healthcare landscape can be transformed. Beyond raising awareness, there is an opportunity to create a robust, equitable, and sustainable system that ensures no patient is left behind, regardless of the rarity of their condition.

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From Communications Strategist to Purpose-Built Leader

Craig began his Boston journey after relocating from Washington, D.C., to join Feinstein Kean Healthcare — a leading consultancy in the life sciences space — as the chosen successor to a founding CEO. There, he furthered his gift for translating scientific and commercial complexity into clear, compelling strategy and narratives. More than a decade later, Feinstein Kean was folded into a holding company, and its name was retired. However, Craig’s Boston roots and passion for guiding life science companies only deepened from there.

Encouraged by his Boston innovation networks, he eventually struck out on his own, founding Rithm Health, a consultancy that advises biotech, digital health, and rare disease companies. It quickly became clear that this wasn’t a sideline gig; it was a mission: supporting companies seeking revenue and impact.

Advisory Leader in the Boston Biopharma Ecosystem

For some 25 years, Craig has advised early- and mid-stage teams—across health categories—on strategy, business development, communications, and patient engagement. His counsel regularly integrates a responsible business mindset and empathy-infused decision-making, often behind the scenes but profoundly influential.

It’s among the many reasons he was invited onto the board of Global Genes years ago and later extended into advisory roles across rare disease nonprofits and biotech initiatives (including the Fibrolamellar Cancer Foundation).

Craig’s long-standing volunteerism at Global Genes evolved into formal leadership: he chaired the Corporate Alliance and shaped the organization’s strategy for diagnostic and treatment equity, clinical trial access, and diversity.  In 2020, he accepted the role of interim CEO, stepping in at a time of transition purely to serve the rare-disease community. Through the next few years, he helped scale the organization globally while preserving its high-touch culture and mission-aligned focus.

Under Craig, the organization prioritized community capacity-building, integrated, personalized service through RARE Concierge, and connecting patients to diagnosis, trials and support —rather than duplicating work in policy or research. His leadership culminated in the seamless reintegration of RARE‑X, bolstering data sharing and patient-driven research approaches under the Global Genes umbrella.

Launching the Orphan Therapeutics Accelerator

Craig built on that experience by founding the Orphan Therapeutics Accelerator (OTXL) in June 2024. Recognizing that many Phase 1/2 rare disease therapies stall—not from scientific failure, but because of funding or infrastructure gaps—he designed OTXL as a nonprofit biotech that sources shelved ultra‑rare programs and drives them forward through development via Orphan ClinDevNet—a coalition of partners delivering low-cost, AI‑enabled services for clinical trials, manufacturing, regulatory readiness and commercialization.

In the traditional biopharma model, promising compounds are often shelved—not due to scientific failure, but because their potential market size is considered too small to justify the cost and complexity of development. This is especially true in the rare and ultra-rare disease space, where patient populations may number in the hundreds or low thousands.

Larger pharmaceutical companies, focused on ROI and portfolio prioritization, frequently set aside these “orphaned” therapies despite early efficacy signals. Craig recognized that these shelved molecules represented more than business decisions; they represented delayed or denied hope for real patient communities. His insight was to operationalize around these forgotten assets, championing their advancement through an entrepreneurial nonprofit model that combines development efficiency, community partnership, novel commercialization pathways, and mission-driven focus.

By aligning with rare disease advocates and building a collaborative ecosystem, Craig’s Orphan Therapeutics Accelerator brings new life to therapies that might never see the clinic.

Leading Founding Members include Chiesi and BIAL, with operations supported by Landmark Bio, Uncommon Cures®, Viralgen, DVLP Medicines, and Vibe Bio. OTXL aims to be financially self‑sustaining within 4–6 years, reinvesting revenue from commercialized programs to support growing rare disease pipelines.

Though now operating globally, Craig maintains an active advisory presence in Boston’s biotech and healthtech sectors. He contributes strategy, governance insight, and rare-disease expertise to companies and nonprofits—and mentors emerging leaders bridging science, patient advocacy, and enterprise.

He’s also appeared at conferences such as Advanced Therapies USA 2025, reflecting his growing profile in the global gene-therapy and pricing-access discussion space.

What We Can All Learn from Craig’s Journey

Craig’s story—spanning executive leadership, consulting firm founding, nonprofit board, interim CEO, and biotech founder—offers five powerful lessons:

1. A compelling narrative is a critical component of strategic leadership. Translating complexity into resonance is more than marketing—it shapes how people connect, invest, and act.

• Empathy drives innovation. Patient insight isn’t an add-on; it’s the organizing principle of strategy.
  
  
• New structures empower neglected science. OTXL’s nonprofit biotech model demonstrates how shelved assets can become viable through purpose-aligned stewardship.

• Community builds momentum. Boston’s collaborative ecosystem supported Craig’s leaps—from Feinstein Kean to independent consultancy—amplifying impact.

• Purpose provides continuity. Across roles, his north star has remained: bring science closer to patients in sustainable, human-focused ways.

Craig Martin reflects what I’ve learned about leadership in health innovation: that proximity—to patients, communities, and complexity—makes the difference. As he told me during our conversation: “The science is often there. The challenge is translation—moving from discovery to delivery.”

In every role, in Boston and beyond, Craig is focused on that translation—one program at a time, one community at a time—with purpose at the center.

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Years of pain – a dim look into a future that might have included a feeding tube or motorized scooter – and being dismissed frequently by the health system – underscore medicine’s shortcomings. The journey from worsening digestive function and painful neuropathy to post-surgical relief highlights an essential truth: The patient’s voice is a critical diagnostic tool, yet it is too often ignored or undervalued.

In two prior published pieces for Medika Life, I explored the challenges of diagnostic complexity and health-systemic fragmentation. In Looking for Zebras, I wrote about medical mysteries and how patients with rare or atypical conditions are often dismissed or misdiagnosed in a system designed to manage the average, not the exceptional. In We Know the Health Ecosystem is Fragmented, Resulting in Rising Costs and Poorer Patient Outcomes, But What Are We Doing About It, I called for centering health delivery around patient outcomes – Health System Kinetics – emphasizing treating patients as whole people rather than their isolated symptoms.

Now, I revisit these themes with renewed urgency and a personal lens, advocating for a health system that listens—to patients, advocates, and their potential to improve people’s lives and reduce care costs.

Listening to the Patient: A Missed Opportunity

For many years, my young adult experienced worsening neuropathy—moving from occasional discomfort to using a cane and eventually a walker. Despite multiple consultations and MRIs, no definitive diagnosis emerged. Physicians, each specialized in their narrow field, treated her symptoms piecemeal: one focused on her spine, another on her joints, and yet another on her nervous system. The resolution was to vary pain medications to address symptoms, adding medicines on top of medicines. The bigger picture was lost in translation, as no single practitioner took ownership of connecting the clinical dots.

This experience is symbolic of the “silo effect” in medicine. Specialization has undoubtedly advanced and, at the same time, compartmentalized the field, creating gaps where Zebra-like conditions like hEDS fall. Worse, when patients like my child describe their experiences—pain, immobility, or even emotional distress—physicians begin to roll their eyes – the worst clinical response. Doctors like patient problems that are easy to fix.

In our case, it took a patient advocate—someone who personally understood hEDS—to guide us toward the right questions and the right specialists. Her lived experience as both a patient and an expert in navigating the system became the linchpin for my child’s eventual on-point diagnosis and treatment. This advocate understood what the health system did not: The interdependence of symptoms and the importance of listening to the patient and looking at the non-obvious puzzle piece.

The Power of Patient Advocacy

Patient advocates bridge the chasm between clinical expertise and lived experience. They translate medical jargon, connect patients with appropriate specialists, and, most importantly, validate the patient’s voice.

In listening to the advocate, I heard the voice of my late father-in-law, Burton Giges, MD, a brilliant clinician who always asked a critical question when addressing complex clinical cases: “What is the underlying cause of the symptoms?” However, as a parent, I was skeptical of the non-medically trained patient advocate who suggested root causes for GI problems whose resolution required surgery. One doctor we consulted from a noted teaching hospital even confronted us, “Who are you going to believe a patient or me?”

Thankfully, we pursued the patient advocate’s counsel and eventually traveled to California to MALS Surgical Specialist Dr. Danny Shouhed. The outcome was a successful MALS surgery to relieve pressure on the celiac artery and restore normal GI blood flow, resulting in normal digestive function. But, like many rare conditions, the medical maze continued.

Our advocate’s role went beyond logistics; she gave us hope when the system offered none. Her guidance led us to a team of specialized neurosurgeons at Brown University Rhode Island Hospital and Patricia Leigh Zadnik Sullivan, MD, Director of the Center for Spine Tumor and Chordoma Research, who confirmed the tethered cord syndrome diagnosis and later performed this complex surgery. Post-operative improvement was almost immediate: reduced neuropathic pain, increased mobility, and a promising sense of physical autonomy not experienced in years.

This transformative outcome raises a critical question: Why did it take an outsider to achieve what the health system itself should have delivered? Advocacy shouldn’t be a workaround but a core component of care.

Reordering Priorities: Outcomes Over Office Visits

The fragmented state of health is not just a disservice to patients; it’s a detriment to the system itself. Rising costs and poor outcomes are direct consequences of this disjointed approach. Each specialist operates within their silo, often incentivized by metrics like the volume of patients seen or procedures performed rather than by long-term outcomes.

In Reordering the Health System’s Priorities, patient outcomes must become the central organizing principle of health access and delivery. This isn’t just a lofty ideal; it’s a practical necessity. A system focused on outcomes would:

1. Promote interdisciplinary collaboration. Specialists must be empowered and incentivized to collaborate, share insights, and co-develop treatment plans.
2. Integrate patient voices. Patients are not passive recipients of care; they are active participants. Their experiences, preferences, and insights must inform individual care plans and broader systemic improvements – not given lip service.
3. Leverage data intelligently. Electronic health records and diagnostic technologies generate vast amounts of data, but it is only valuable if synthesized into actionable insights. Medical teams must use technologies – AI, ChatGPT, and LLMs to connect dots and see patterns that might usually be overlooked.

Had these principles been in place, my child’s correct diagnosis might have come months, even years, earlier. Instead, it took an advocate outside the system to untangle the threads.

The Hidden Costs of Ignoring Patients

When the health ecosystem discounts patient experience, it fails individuals and incurs added costs. Delayed diagnoses lead to prolonged suffering, reduced quality of life, and higher medical expenses. For our family, years of neuropathy meant not only physical pain but also the emotional toll of feeling unheard and unseen.

Moreover, the economic implications are staggering. Treating symptoms in isolation often leads to more office visits, redundant tests, unnecessary procedures, and avoidable complications. A study published in Health Affairs estimated that diagnostic errors alone cost the US health system billions annually, to say nothing of the human cost.

Listening to patients isn’t just compassionate; it’s cost-effective. Their insights can streamline diagnostic processes, reduce unnecessary interventions, and improve adherence to treatment plans—all of which contribute to better outcomes and lower costs. But to make that possible, medical teams need to be trained differently and incentivized to listen – not just hear words.

Transforming the System – Three Tips to Make Healthcare More Caring

So, how do we create a health system that listens?

1. Train Physicians to See the Whole Person

Medical education must evolve to emphasize holistic, patient-centered care. This means training doctors to consider the interplay of physical, emotional, and social factors—and to listen deeply to their patients. Breaking down silos requires structural changes, such as multidisciplinary clinics where specialists work side by side, sharing insights and jointly managing complex cases.

2. Integrate Advocacy into the Care System

Patient advocacy should be institutionalized, not incidental. Hospitals and clinics should employ patient advocates as part of care teams, ensuring every patient can tap into a guide to navigate the system’s complexities.  Payers should consider employing patients who can objectively call upon their experiences to ask questions as ambassadors for better care.

3. Measure What Matters

Health organizations must redefine success metrics. Instead of focusing on patient volume or efficiency, they should prioritize metrics that reflect patient well-being, such as functional outcomes, quality of life, and patient satisfaction. My child can now feel surfaces with their feet – impossible before because of painful neuropathy. They feel they are “walking on the moon.”

Communication is Part of the Care

Like many others, our journey highlights the system’s failures and amazing potential. It is a sobering reminder that while medical science has made extraordinary strides, it is still fallibly human. We look to the magic of AI, ChatGPT, and LLMs to resolve problems, but in our rush to innovate and specialize, we have lost sight of the most fundamental aspect of care: listening.

Patients are not puzzles to be solved or cases to be closed; they are people with stories, insights, and wisdom to share—they hope for a healthier future. By listening, we can bridge the gaps in care, transforming outcomes and the experience of the care journey.  

As we look forward, remember that the most powerful diagnostic tool is not a test or a scan but the patient’s voice. Let us not dismiss it – but use it.

[My gratitude to the Marfan Foundation, Nieca Goldberg, MD, CNS Summit, Rachel Lee, Patient Advocacy Consulting, FINN Partners, Danny Shouhed, MD, Residence Inn by Marriott, and the many patient advocates I’ve met through the years who champion the voice of people in the care trenches]

The post Looking for Zebras: Listening to Patients, Healing the Health System appeared first on Medika Life.

Attending the conference alongside my mentor Shazia Ahmad, the Senior Director and Head of Patient and Physician Services at UBC was a meaningful educational opportunity. I am not a stranger to the rare disease community, as my brother received treatment at age 5 for Macrophage Activation Syndrome, Hemophagocytic lymphohistiocytosis, and atypical presentation of idiopathic Juvenile Rheumatoid Arthritis. I felt as though my family may have been the only ones to confront such a grueling experience, however while attending Rare Disease Day, I came to appreciate that the rare disease community is made up of over 300 million patients plus researchers, caregivers and physicians all working together helping those afflicted.

The feeling of hope for treatments of each rare disease vibrated through the room. These vibrations were expressed by Sharon J. King, Advocacy and Community Engagement Manager at Alevron, who said “hope is like air.” She explained that hope is what carried her through her personal journey as she lost her daughter to a rare disease. Using King’s analogy, the conference center had an abundant supply of air, or hope, that day. Conference members answered calls of hope with new products as well as new projects with the Genetic and Rare Disease (GUARD) Information Center, Rare Disease Alert System, Platform Vector Gene Therapy, and many more.

The GUARD Informatic Center would have been a lightning strike in a field of darkness during the diagnosis of exclusion process that my parents had to navigate with my brother.  I watched my parents endure sleepless nights by compiling stacks of information into binders to fight to find the rare disease from which he was suffering. With applications like GUARD Information Center, hours of frustration as well as fear would have been alleviated by having a special database of all rare diseases. 

Attending sessions and listening to dialogue conversations between patients, physicians, companies, and political figures, was inspiring and educational. Questions were asked in both directions for what can be done to meet the community’s needs in every aspect of care. This encounter exemplified Kristen Wheeden, President of the United Porphyrias Association and Rare Disease Caregiver point of who is really the expert when it comes to rare diseases. Is it patients or physicians or someone else? This ongoing theme during the conference epitomizes the success of the rare disease community being dependent on each other. These heartfelt and emotional discussions displayed the need for even more cooperation to make bigger strides toward progress.

As stated by Joni L. Rutter, Ph.D., Director of the National Center for Advancing Translational Sciences (NCATS) at the NIH, the rare disease community not only wants more treatments, but also cures for more people. The more people Rutter referenced were the often forgotten groups within the rare disease community. These micro-communities finally got their long overdue spotlight on February 28th with meaningful discussions about how different organizations work to ensure that research and treatments are inclusive to their populations.

The conference was even united in their stylistic choice of attire, zebra stripes. The symbolic representation of duality, determination, empowerment, and community.  The perfect choice.

Despite amazing efforts made that were highlighted during rare disease day, this is only the start. It is vital that hope continues, and efforts are combined within the rare disease community to create more change. As Shazia Ahmad said, “we need advocacy and industry to work together to accelerate progress.” What began on the morning of February 28th is an extraordinary beginning, but thankfully not the end.

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Dion has long struggled with muscle spasms, as she explains in her Instagram video:

“While we’re still learning about this rare condition, we now know this is what’s been causing all of the spasms that I’ve been having. Unfortunately, these spasms affect every aspect of my daily life, sometimes causing difficulties when I walk and not allowing me to use my vocal cords to sing the way I’m used to.”

Today, we explore stiff-person syndrome, a rare neurological condition that strikes approximately one in a million individuals, according to the US National Organization for Rare Disorders (NORD).

Stiff-person syndrome

Stiff-person syndrome (SPS) is a rare acquired neurological problem marked by progressively worsening rigidity and repetitive painful muscle spasms. SPS affects twice as many women as men.

Symptoms

Common symptoms associated with the disorder include the following:

• Stiff muscles, including the trunk, arms, and legs
• Sensitivity to noise, touch, and emotional distress (which can precipitate muscle spasms)

Stiff-person syndrome is considered a spectrum of diseases ranging from the involvement of one body area to a widespread, rapidly progressive form that includes the involvement of the brain stem and spinal cord (progressive encephalomyelitis with rigidity and myoclonus (PERM)).

Over time, those with stiff-person syndrome may develop abnormal postures, appearing hunched over. Some individuals may become unable to walk or move. Lacking normal reflexes to catch themselves is particularly problematic as serious injury risk rises.

Putting it all together, you can imagine that many people with SPS can become fearful of leaving their homes because of street noise (for example, a car horn) that can trigger muscle spasms and falls.

Causes

The cause of the stiff-person syndrome remains unknown, but researchers believe it is an autoimmune response gone awry in the spinal cord and brain.

Here is the take of Dr. Richard Nowak, an assistant neurology professor at the Yale School of Medicine: “Stiff-person syndrome overall disrupts the normal communication pathways between the brain and the muscles. He adds:

“There’s a massive firing occurring from the central nervous system, down through the spinal cord, down through the nerves as they plug into the muscles, and it’s causing them to become rigid or go into spasm, which equals the stiffness.”

SPS is frequently associated with other autoimmune diseases, including type-1 diabetes and vitiligo (a disease that causes loss of skin color in patches). SPS may also be associated with thyroiditis and pernicious anemia (a condition in which the body does not have enough healthy red blood cells).

Most (but not all) individuals with SPS have elevated antibodies targeting a protein involved in muscle function control.

Dr. Simon Helfgott, a rheumatologist at Harvard Medical School, explains that about two-thirds of stiff-person patients have these antibodies, detectable by a blood test. For the 30 percent that don’t, researchers do not fully comprehend what is driving the condition.

Dr. Helfogott adds that a small proportion of those with cancer produce antibodies attacking the nervous system and triggering SPS. This phenomenon is a paraneoplastic-related stiff-person syndrome.

Treatment and prognosis

Symptoms can improve with an oral anti-anxiety drug (diazepam; Valium). This medicine works by calming the brain and nerves. Diazepam belongs to a class of drugs known as benzodiazepines.

For those with SPS, other medication types that should be avoided include serotonin-norepinephrine reuptake inhibitors (SNRIs; selected examples include tricyclic antidepressants and duloxetine).

Opioids are not recommended for pain because most people with SPS are on benzodiazepines. Mixing these two medication classes can lead to severe respiratory depression and death.

Drugs that may target muscle spasms may be added. Examples of such medicines include baclofen or gabapentin (Neurontin). Botox injections may be palliative for those with milder symptoms, including spasms.

Patients with more severe symptoms are often given immunoglobulin (by vein). Such infusions can reduce stiffness and noise, touch, and stress sensitivity.

Appropriate management may keep symptoms under control. Still, the natural history of SPS is unpredictable. Some remain stable for a decade, while others slowly decline over several months or a few years.

“I have a great team of doctors working alongside me to help me get better,” Dion volunteered on Instagram.

Thank you for joining me for this brief look at stiff-person syndrome (SPS). I wish Celine Dion all the best.

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