High Costs, Off-Label Use, and Black Box Warnings: What Rituximab Taught me About Questioning Any Drug

by Linda Wulf | Mar 2, 2026 | Main Blog | 0 comments

When a doctor prescribes a medication, how much do we really know about why it’s being used for our condition? How effective it is? How it was approved, and what it’s supposed to do? Does it help my condition?  Is it off-label and exactly what does that mean?

A couple of years ago, I found myself in a hospital room with a brand-new diagnosis: a “rare disease”—an inoperable, incurable brain cancer (primary central nervous system lymphoma, or PCNSL). This was not how I pictured my later years. From the moment I arrived at Mayo Clinic, I knew my issues were tied to my teeth—a systemic dental infection fueling inflammation throughout my cranium. I eventually found my path to wholeness, but along the way, I learned things I wish I’d known sooner. If this resonates, maybe it’ll help you too.

I’ve covered key pieces of this puzzle in previous articles on my site (jjunr.com):

• To better understand the history of research funding for drugs to help people with rare diseases read: When Good Intentions Become an Industry
• How the government established the framework to support this rare disease (e.g., Orphan Drug Act and beyond) read: From Temporary Fix to Permanent System
• How we have a thriving industry that creates drugs and finds new rare diseases every year but fails to cure anything—the focus is on disease “management,” while ignoring toxins or potential causes: What We Have Really Created: A Self-Perpetuating Industry and No Cause, No Cure
• My life now is disease-free and freed from the system because I understood and addressed the source you can read about it here: Breaking Free—One Patient’s Real-World Proof That “Incurable” Is a Lie and The Brain’s Amazing Ability to Regenerate: Neurogenesis & My Journey

And in The Night I Saw Pharma’s Names on My Cancer Protocol, I tie it all together—revealing the interconnectedness of the industry (standard protocols and their connections with pharma-driven solution) versus the patient’s lived reality, choices, and potential for root-cause healing outside the system.

This piece focuses on the medications themselves—how the industry evolved, and what it means for anyone caught in it. ...Read More

Breaking Free – One Patient’s Real-World Proof That “Incurable” Is a Lie

by Linda Wulf | Feb 2, 2026 | Main Blog | 0 comments

Part 4 of 4

For the last three parts, we’ve traced how the Orphan Drug Act of 1983 started with genuine compassion, how the Rare Diseases Act of 2002 turned rare conditions into permanent federal infrastructure, and how the result is a trillion-dollar self-perpetuating industry that multiplies labels, inflates spending, and rewards management over cures. The system has no incentive to reduce disease prevalence, no requirement to prove fewer people need lifelong therapy, and no interest in exploring root causes when pharmaceutical control is more profitable.

What follows is real-world counter-evidence—one patient’s outcome that challenges the prevailing model. This is my story.

In late 2023, I was diagnosed with Primary CNS Lymphoma (PCNSL)—a “rare, aggressive, incurable” brain cancer. The standard protocol calls for high-dose methotrexate (HD-MTX), rituximab, temozolomide, and lifelong maintenance or repeated cycles of HD-MTX to keep this cancer from returning. If I was “lucky,” after 5-6 rounds, I’d qualify for an autologous stem cell transplant—harvesting my own cells to rebuild marrow destroyed by the chemo, all while the industry search for a “cure” drags on.  A search first formalized in 1971 by Richard Nixon with the National Cancer Act, when he announced that if we can cure Hodgkin’s we can cure cancer.

At my doctor’s urging, I started HD-MTX just 10 days after landing in the ER—and a week after heavy antibiotics targeted what I believed was the real trigger: an active and chronic dental infection sparking my body’s lymphatic overreaction.  While I was learning about the healthcare system and finding my way out, I went through four cycles of HD-MTX, and one dose each of rituximab and temozolomide.

By January 17, 2024, I’d gathered enough intel to plot my escape. Navigating my healthcare portal, I scrutinized my brain scans. What I saw didn’t scream “aggressive”—no rapid changes, just a body responding. It made more sense to challenge the story I was being told than to continue poisoning myself. I was learning in real time, unraveling rules and assumptions I wished I had known before the diagnosis.  |

 That day, admitted for what became my final cycle of HD-MTX, I refused anti-nausea meds. Vomiting, I argued, was my body’s natural defense against toxins—something it had done with cigarettes, alcohol, or even overwhelming experiences in my past. Why suppress that signal? Andrew Walker, the PA on shift, came in to talk. He listened thoughtfully as I shared my journey, my search for truth, and my question: Was it the antibiotics, the steroids or MTX driving any response? When he walked out that door, I expected to be shown the door—maybe even discharged from the program after he talked with the team.

 Instead, he returned with “the Team” –  Dr. Mrugala, Dr. Rosenthal, and others. The team couldn’t risk uncontrolled vomiting—I understood that.  I told them plainly I believed my body could heal if I addressed the root cause.  I said ” I am fearfully and wonderfully made.”

They listened, whether they heard me or were just nodding in agreement to get past this crisis. In my mind, I had just agreed to this last round, including anti-nausea for safety, on one condition: I’d head home to my octogenarian periodontist to tackle the infection. And that’s what I did. Looking back now, with everything I know, I would have left Mayo’s care on day 9—before ever starting chemotherapy. But fear and pressure kept me in longer than I should have stayed.

Fast-forward two years. My January 2026 MRI shows continued stability, with no new lesions and no meaningful progression of FLAIR hyperintensities. In the side-by-side comparison, the earlier scan (right) resembles a “lion’s face,” its mane formed by flaring abnormalities around the brain’s center. In the most recent image (left), those features appear subdued and organized—the central structures tamed, the brain moving from roaring to resting.

On January 19, 2026, I returned to my doctor, and we reviewed the imaging. We agreed that I would permanently step away from Mayo Clinic’s monitoring of my “disease.” There was no fanfare when I walked out—no longer their patient. No one is ringing my “I beat cancer” bell but me.

I am no longer living on borrowed time.  I am living on healing on my terms—without endless toxicity.

• The system is structured around features that are rarely disclosed to patients. These are the priorities and mechanisms I wish I had understood earlier:Drugs are prioritized over whole-body health. Medical care often follows rigid treatment playbooks that focus on pharmaceuticals, and once those regiments are established, they are rarely questioned or revisited.
• Suppression replaces biological support. Rather than helping the body’s natural defense systems do their job, many treatments are designed to shut them down—most notably by targeting the lymphatic and immune systems first, even as they are actively working to protect and stabilize the body.
• Approvals continue without ongoing proof. Once a drug is approved, it can remain in use indefinitely, even when long-term effectiveness is not regularly re-evaluated or meaningfully tracked.
• Rules are bent for labels, not outcomes. Regulatory flexibility around “rare” disease classifications serve faster approvals and bureaucratic objectives rather than ensuring real, patient-centered results.
• Important gaps are left uncovered. Insurance routinely excludes testing that could explain ongoing symptoms—such as evaluations for gadolinium toxicity—simply because those tests fall outside standard pathways.
• Drugs gain freedom, patients do not. After approval for a single cancer indication, drugs can be reused broadly in small patient groups without rigorous endpoints, long-term follow-up, or meaningful outcome tracking.
• Treatment rules are shaped by industry. Pharmaceutical companies develop the drugs, influence testing, and help shape hospital protocols—often through industry-entangled organizations like National Comprehensive Cancer Network—aligning care more closely with profit and stock performance than with patients’ long-term well-being.
• Language is used to narrow choices. Fear-based terms like “aggressive,” “incurable,” and “unbeatable” are routinely used to frame disease, discouraging questions and implying patient helplessness rather than describing biological reality.
• Patients are kept in a treatment loop. Most are never told that stopping, monitoring, or supporting the body is an option, ensuring continued enrollment in regiments that sustain dependency, funding streams, registries, and repeat interventions instead of resolution.

My message to anyone reading this series: You are not a disease label. Your body is remarkable. When the protocol feels like destruction, question it. Seek second opinions. Trust your intuition. Explore nutrition, detoxification, inflammation reduction, and lifestyle—the things the system sidelines because they can’t be patented or scaled. Healing is possible. Freedom is possible.

The industry we have created thrives on dependency. But individuals can break free—and when we do, we prove the whole narrative wrong.

What We have Really Created: A Self-Perpetuating Industry

by Linda Wulf | Feb 2, 2026 | Main Blog | 0 comments

Part 3 of 4

The Orphan Drug Act of 1983 and the Rare Diseases Act of 2002 were intended to reduce suffering by accelerating cures for rare conditions.

After more than four decades and billions in public spending, rare diseases have not diminished. They have multiplied—while an already bloated government spending program continues to expand, with no indication of an endpoint.

This is what has happened:

The Growth in Identified Rare Diseases

From just over 6,000 recognized in 2002, the count now exceeds 10,000 (per NIH, NORD, and Orphanet estimates as of 2025–2026), with new subtypes and classifications added yearly through advances in genetics, molecular diagnostics, and data aggregation. This outcome is not accidental; it is a feature of the current model.

More labels translate to more patients identified, more protocols developed, and more lifelong management—not fewer people suffering. The economic burden reflects the same pattern: Rare diseases cost the U.S. nearly $1 trillion annually. Trillions are being spent collectively, yet meaningful reductions in prevalence or treatment dependency remain elusive. The overwhelming majority of rare diseases still have no cure; only about 5% have FDA-approved treatments.

Government Spending by Agency (Billions USD)

The increase in identified diseases correlates directly with massive increases in public spending, particularly on healthcare coverage (Medicare/Medicaid) as opposed to core research (NIH).

Activity vs. Progress

This outcome is by design. The system equates activity with progress: more grants awarded, more registries established, more approvals granted, more subtypes defined. Incentives reward participation and expansion—tax credits, market exclusivity, public-private collaborations—but impose no outcome-based accountability. There is no requirement to demonstrate fewer patients over time, fewer people needing lifelong therapy, or actual disease reduction. When prevalence rises or new diagnostic categories emerge, the funding continues unabated.

Regulatory flexibility, originally intended to address small patient populations, has granted pharmaceutical companies considerable leeway:

• Smaller Trials: Often involving only dozens of participants rather than thousands.
• Surrogate Endpoints: Using laboratory markers deemed “reasonably likely” to predict benefit, rather than direct evidence of clinical improvement like extended survival.
• Accelerated Approvals: Allowing initial marketing based on weaker data while post-approval confirmatory studies are frequently delayed or remain incomplete.

What began as exceptional accommodation has become routine, lowering evidentiary thresholds and enabling more drugs to reach the market with limited proof of resolving the underlying disease.

The Transparency Gap and Sidelined Interventions

Patients frequently receive incomplete information. While physicians must obtain informed consent, no federal rule mandates explicit disclosure that a drug is being used off-label, that supporting evidence derives from small trials or surrogate markers, or that long-term benefits and risks remain uncertain. This transparency gap places the full burden of uncertainty and potential harm squarely on the patient.

Non-patentable interventions—chronic infections, inflammatory drivers, environmental exposures, nutritional optimization, metabolic repair—are systematically sidelined. They lack the exclusivity or high-margin potential needed to attract large-scale funding or study. The system overwhelmingly favors scalable, reimbursable pharmaceutical solutions over investigation of root causes.

The human toll is profound and unforgivable. Patients endure aggressive, body-destroying regimens while underlying triggers go unexplored. They are told their disease is aggressive, rare, and incurable, then funneled into protocols designed for control rather than resolution.

What we really have created is a massive, well-funded, self-perpetuating industry: government-business partnerships, advocacy ecosystems, and lifelong treatment protocols—all thriving on more recognized diseases, more spending, and more dependency. Not progress. Institutionalized failure.

The next part begins at the moment a patient realizes they are not being guided toward recovery but managed as an endpoint in a system with no incentive to make them well—and decides to leave it.

From Temporary Fix to Permanent System

by Linda Wulf | Feb 2, 2026 | Main Blog | 0 comments

The Rare Diseases Act of 2002 — Part 2 of 4

How Rare Disease Became Federal Infrastructure

Part 1 examined how the Orphan Drug Act of 1983 used incentives to correct a market failure—and why it worked. But that law was never intended to create a permanent system.

In 2002, that changed. With the Rare Diseases Act, rare diseases stopped being an exception to the medical marketplace and became embedded in the federal research infrastructure itself. This essay examines how a temporary solution quietly sowed the seeds for something much larger, with consequences that were not anticipated at the time.

The Orphan Drug Act of 1983 has proven its value. By offering tax credits, grants, and seven years of market exclusivity, it spurred hundreds of orphan drug designations and approvals where none had existed before. What was once a neglected corner of medicine began to attract real investment. But the law’s incentives were narrowly focused on drug development—temporary bridges over a market gap. Rare diseases were addressed as exceptions, not yet embedded as a standing priority within the medical system.

In 2002, Congress took the next step. On November 6, President George W. Bush signed the Rare Diseases Act into law. Unlike the Orphan Drug Act, which relied on pharmaceutical incentives, this legislation embedded rare diseases directly into the federal research infrastructure at the National Institutes of Health (NIH).

The Act’s congressional findings captured the scale of the problem at the time: more than 6,000 known rare diseases affecting an estimated 25 million Americans, many of whom lacked effective treatments due to limited commercial interest. The law sought to address this by formalizing rare disease research through several key mechanisms:

• Establishing a statutory Office of Rare Diseases—now the Office of Rare Diseases Research (ORDR) within the National Center for Advancing Translational Sciences—to coordinate NIH efforts
• Recommending a national research agenda for rare diseases
• Supporting education, workshops, and symposia to identify research opportunities
• Authorizing grants for regional centers of excellence, which led to the creation of the Rare Diseases Clinical Research Network (RDCRN) to support collaborative clinical studies, training, and patient engagement

The Act also standardized the definition of a rare disease as any condition affecting fewer than 200,000 people in the United States—the same threshold used in the Orphan Drug Act—and authorized modest appropriations (approximately $4 million annually from FY 2003–2006). Though limited in dollar terms, this funding signaled a long-term federal commitment.

The shift was profound. Rare diseases were no longer addressed solely through targeted incentives; they became a formalized category within federal medicine, complete with dedicated offices, recurring grant pipelines, disease registries, and collaborative frameworks linking government, academia, industry, and advocacy organizations. Across this ecosystem, sustained participation—not resolution—was rewarded.

Since 2002, this infrastructure has driven substantial investment. Federal funding coordinated through ORDR, RDCRN cycles, and related NIH grants is estimated at $2–4 billion, with RDCRN alone exceeding $500–600 million across its five funding cycles. The system expanded research capacity, built networks, and increased visibility for rare conditions. But the numbers also reveal a deeper paradox. While the 2002 Act referenced roughly 6,000 known rare diseases, the recognized total has since climbed well beyond 10,000. This increase is often attributed to advances in genetics, molecular diagnostics, and data aggregation—suggesting that many conditions always existed but were previously unidentified. Yet that explanation is incomplete.

Over the same period, Americans have experienced unprecedented and cumulative exposure to thousands of synthetic chemicals, food additives, pharmaceuticals, and environmental contaminants—many approved under fragmented regulatory oversight and rarely studied for long-term, low-dose, or synergistic effects. Rather than asking whether this expanding chemical burden is contributing to disease emergence, the system has largely focused on classification and management after the fact. More diseases are cataloged, more subtypes defined, and more patients enrolled—not necessarily because detection has improved alone, but because upstream causes remain unaddressed.

Rare disease was now a permanent federal program to manage, not a temporary gap to close. No built-in mechanisms required measuring reductions in disease prevalence, cures achieved, or fewer patients needing lifelong care. Success became increasingly tied to activity—more studies, more centers, more funding—rather than to resolution.

What began as compassion had evolved into something enduring: a formal system with billions invested, expanding infrastructure, and a growing catalog of recognized diseases. After more than four decades, what has that investment actually produced?

When Good Intentions Become an Industry

by Linda Wulf | Feb 2, 2026 | Main Blog | 0 comments

When Compassion Met Incentives: The Orphan Drug Act of 1983 (Part 1 of 4)

In the late 1970s and early 1980s, families across America watched helplessly as loved ones died from rare diseases—conditions so uncommon that pharmaceutical companies saw little profit in developing treatments. Doctors had few options. Researchers had limited funding. Patients had no real leverage. These “orphan” diseases affected small populations, often fewer than 200,000 Americans, making them unappealing to market-driven drug development.

Congress responded with bipartisan urgency. On January 4, 1983, President Ronald Reagan signed the Orphan Drug Act (ODA) into law, amending the Federal Food, Drug, and Cosmetic Act to encourage the creation of drugs for rare diseases.

The core idea was simple and humane: If private industry wouldn’t invest because the patient pool was too small to recoup costs, the government would make it worthwhile through targeted incentives. Those incentives were designed to reduce risk, shorten timelines, and make rare disease research economically viable.

Key provisions included:

• Orphan drug designation: Companies could apply to the FDA for a drug to be designated as an “orphan” if it targeted a rare disease (defined as affecting < 200,000 people in the U.S., or more if no reasonable expectation of profitability). This unlocked benefits early in development.
• Tax credits: Up to 50% of qualified clinical trial costs could be claimed as a credit, reducing the financial burden of research.
• Market exclusivity: Upon FDA approval, the first sponsor received seven years of exclusive marketing rights for that drug in treating the designated rare condition—no direct competitors could enter the market during that period.
• Grant funding: The FDA’s Office of Orphan Products Development awarded research grants to support orphan drug studies.
• Fee waivers: Exemption from Prescription Drug User Fee Act (PDUFA) application fees.
• Regulatory support: Priority review, closer FDA coordination, and access to expedited pathways.

These carrots worked. Before 1983, the FDA had approved only about 10 drugs that would qualify as orphans. In the decades since, hundreds of orphan designations have led to over 500 approvals for rare disease treatments, transforming what was once a neglected area into one of sustained innovation.

At its heart, the 1983 Act was an act of compassion translated into policy—bridging a market failure to give hope to patients long ignored. It proved that targeted government intervention could spur private investment where pure economics had failed.

Yet this success planted seeds for what came next: a system that, over time, grew far beyond its original intent.

What began as a targeted solution to a market failure would not remain temporary. In the years that followed, rare disease moved from exception to infrastructure—embedded into federal research, funding, and regulation.

In Part 2, we’ll examine how that shift became permanent with the Rare Diseases Act of 2002—and how a bridge turned into a system designed to run indefinitely.