A significant number of cancer drugs approved since 2000, as reviewed by Bloomberg News, have never been definitively shown to extend patient survival for their approved uses. This raises questions about the growing cost of cancer treatments.
The landscape of cancer treatment has been revolutionized over the past three decades, with over 200 new cancer drugs greenlit by the US Food and Drug Administration (FDA). This surge, driven by legislation backed by pharmaceutical companies, has transformed oncology into a massive industry. It generated at least $200 billion in worldwide sales last year alone. Yet, beneath the veneer of progress lies a growing concern. Many of these costly treatments may not be delivering the life-extending benefits patients desperately seek, despite the high cost of cancer treatments.
The Rising Tide of Uncertainty
A significant number of cancer drugs approved since 2000, as reviewed by Bloomberg News, have never been definitively shown to extend patient survival for their approved uses. Even fewer have demonstrated an improvement in cancer-related symptoms or overall quality of life. In fact, over the past decade, drugmakers have earned more than $50 billion from cancer drugs that, to date, lack proven survival benefits. Thus, the cost of cancer treatments becomes a pressing issue when compared to the actual benefits provided.
One stark example is Pfizer’s Ibrance, a top-selling drug for advanced breast cancer. Despite its annual cost soaring to $214,000, clinical trials have not conclusively proven it extends patients' lives. However, it has been shown to shrink tumors. Stacie Dusetzina, a cancer policy researcher, highlighted the immense frustration and financial burden this poses. Her mother potentially faces out-of-pocket costs of around $10,000 annually for a drug with unproven long-term survival advantages. This further illustrates the high cost of cancer treatments.
Progression-Free Survival: A Controversial Metric
A key factor in the expedited approval of many new cancer drugs is the reliance on "progression-free survival" (PFS), a measure of how long a drug delays tumor growth. While researchers initially assumed a direct link between delayed tumor growth and extended life, recent studies indicate this correlation is not always clear-cut. For instance, Ibrance's approval was largely based on demonstrating a 10-month improvement in this metric. Yet, a 2022 study found no statistically meaningful improvement in overall survival for women with advanced breast cancer using the drug.
Richard Sullivan, a professor of cancer and global health at King’s College London, said there is a myth that these cancer drugs are saving enormous numbers of lives, but it is not true. An analysis in JAMA Oncology estimated that four out of five cancer deaths averted from 1975 to 2020 were due to improved screening and preventive health measures, rather than new treatments.
The Cancer Industrial Complex and Regulatory Shifts
The current landscape, dubbed by some as the "cancer industrial complex," is partially attributed to shifts within regulatory bodies like the FDA. The agency now receives almost half of its $7 billion annual budget from fees paid by drug companies and medical device manufacturers. This funding model has contributed to accelerated approval pathways. It allows drugs to reach the market faster, sometimes based on preliminary data and shorter-term clinical measures, such as progression-free survival (PFS).
Richard Pazdur, the long-standing chief of the FDA's oncology division, has been a key figure in this shift. He advocates for streamlined review processes. While this approach is popular with some patient groups eager for new options, it has also led to products with uncertain benefits remaining on the market for years. This burdens patients with potentially unnecessary treatments and side effects, further exacerbating concerns regarding the cost of cancer treatments.
Financial Implications and Patient Impact
The financial strain on healthcare systems and patients is undeniable. The median initial price of a new cancer drug has quadrupled after inflation since the early 2000s. It has reached approximately $25,000 per month in recent years. Meanwhile, a forthcoming study from Columbia University suggests that the average new drug improves survival by only about three months. This raises serious questions about the cost of cancer treatments.
Seeking Higher Standards
A growing number of cancer specialists are advocating for a return to higher standards in clinical trials. Groups like Common Sense Oncology, founded in 2023, are pushing for more robust evidence of overall survival and quality of life improvements. They argue that while new drugs offer hope, it can sometimes be "false hope." They generate billions for drug companies while patients incur significant costs for uncertain benefits.
The focus on profits also raises concerns about dosage and duration of treatment. Studies indicate that some recommended dosages may be unnecessarily high. They show treatments administered for longer than required. This further contributes to costs and potential side effects. Thus, the cost of cancer treatments remains a crucial issue.
As discussions about drug pricing and regulatory oversight intensify, the critical question remains. How can we ensure that the pursuit of innovation in cancer treatment translates into tangible, life-saving benefits for patients, rather than primarily serving the pharmaceutical industry's bottom line?