Even as a Pharma Insider, I Worry that the Pharma Industry Can Sometimes Bankrupt Patients

While the pharmaceutical industry can function to create life-saving drugs, it’s time the industry underwent significant change.   Over my 25 years of experience launching drugs for cancer, rare diseases, and immunologic illnesses, while working for Fortune 100 companies and start-ups, I've seen amazing progress, but also some troubling issues.

The Promise of Pharmaceuticals

The main goal of the pharmaceutical industry is to develop treatments that improve and save lives. In cancer treatment, new drugs have turned what used to be dire diagnoses into chronic conditions. For example, some targeted therapies and immunotherapies have greatly increased survival rates and improved quality of life.

Rare diseases have also seen big advancements. Conditions like Spinal Muscular Atrophy (SMA) and Duchenne Muscular Dystrophy, which were once untreatable, now have approved medications and many in development that offer hope to patients and families.

In immunology, therapies like monoclonal antibodies have changed how we treat autoimmune diseases, giving relief to patients who couldn't find help elsewhere.

These breakthroughs show how important the pharmaceutical industry is in advancing medical science.

The Profit Problem

One of the big issues in the industry, however, is its focus on profit. Developing a new drug can cost over $4 billion, which means companies need to make a lot of money to recoup their costs and generate profit for their shareholders. Sometimes, this focus on profit makes drugs very expensive, putting them out of reach for many patients.

For example, cancer drugs can cost tens of thousands of dollars per month, making it hard for patients to afford life-saving treatments. This raises ethical questions such as: Are companies putting profits before people?

Developing drugs for rare diseases is also very costly and risky. While incentives to develop these drugs are necessary, they can lead to very high prices. An example is Spinraza, a drug for Spinal Muscular Atrophy. When it was first approved, it could cost $750,000 for the first year and $375,000 per year after that, making it too expensive for all but the most affluent patients or those with extraordinary insurance coverage.

While government insurance such as Medicare and Medicaid, and private insurance, help to cover some of the costs, for people without insurance the costs can be financially
devastating and can lead to medical bankruptcy.  Imagine having an insurance plan that pays 80% of a medication cost, while the patient pays 20%.   The cost of the medication  is $100,000.  That means the patient (or the parent of a child who is a patient) The needs $20,000 just to cover the initial cost of one medication.  That isn’t possible for most people. 

Navigating Ethical Waters

Finding a balance between making money and helping patients is tricky. Big pharmaceutical companies spend a lot on research and development, so they look for a return on their investment. But focusing too much on profit can mean putting patient needs second. 

Case Study: The Oncology Market

Take a new cancer drug that costs $150,000 a year. It might help patients live longer and stay healthier during that extra lifespan, but its high price means not everyone can afford it. This raises an ethical dilemma: should life-saving treatments only be available to the wealthy? A clear example of this issue is CAR-T cell therapy, a personalized cancer treatment. It works incredibly well for some people, but it can cost up to $500,000.

Addressing Rare Diseases: The Sky-High Costs

Rare diseases also face this challenge. Developing drugs for small patient groups is costly and risky. The Orphan Drug Act of 1983 encourages companies to create these drugs by offering special incentives, but it also lets them set very high prices.  Spinraza, a treatment for Spinal Muscular Atrophy, initially cost a whopping $805,000 for the first year and $308,000 per year, thereafter.
Immunology: Balancing Breakthroughs with Affordability

In immunology, drugs like Humira and Enbrel have significantly improved the lives of people with autoimmune diseases like rheumatoid arthritis and Crohn's disease. However, these drugs can cost over $40,000 a year, making them unaffordable for many patients. The pricing issues here are like those in the insulin market, where essential drugs become increasingly expensive, putting pressure on patients who depend on them.

Philosophical Reflections and Future Directions

Reflecting on my extensive experience, it's clear that the pharmaceutical industry walks a fine line. Companies need to innovate and bring new treatments to market while also making enough money to sustain their business. This balance often results in heated debates about whether companies are doing the right thing ethically.

To ensure the sustainability of pharmaceutical innovation, we need to focus more on patient-centered approaches. One idea is value-based pricing, where a drug’s price reflects its effectiveness and the benefits it provides to patients. Governments, insurance companies, and pharmaceutical companies should work together to make essential drugs more accessible without stifling innovation.

Conclusion: The Path Forward

The pharmaceutical industry is crucial to modern medicine, driving significant advancements in healthcare. However, my experience in launching oncology, rare disease, and immunology medications reveals a complex, often contentious balance between innovation and profit. While the need for medications and their lifesaving potential is undisputed, it is equally essential to address the tendency to prioritize profits over patient access and affordability.

Moving forward, a combined effort from pharma companies, healthcare providers, policymakers, and patient advocacy groups is necessary to create a more equitable system. Innovation should not come at the expense of accessibility, and profitability should not overshadow the primary aim of improving patient health. By adopting a balanced approach, the pharmaceutical industry can fulfill its promise of delivering life-changing treatments to all who need them.

Kathryn Munoz, PhD, MPH is a co-founder of the Biopharma Accelerator Program (https://www.biopharmacoachpro.com/).  She has worked in the biopharmaceutical industry for over twenty years, gaining extensive experience in areas such as medical affairs, health economics, outcomes research, market access, and sales. Her contributions have had a significant impact on the industry's business strategies, product development, and initiatives aimed at providing patients with access to medications. She is also a dedicated mentor to biopharmaceutical professionals, committed to nurturing new talent and fostering innovation.