In theory, getting promising new cancer drugs to patients quickly sounds like a great goal. After all, cancer claims the lives of thousands—in fact, chances are each one of us knows a friend or loved one who has faced this insurmountable disease.
Why wouldn’t we grab every tool in our arsenal to help stop this illness?
The problem is, this rush to market for new cancer drugs may have a dark underside…
In fact, the FDA’s accelerated approval pathway for these drugs, designed to speed up access to potentially life-saving treatments, has come under scrutiny.
And the findings are alarming.
The Fast Track to Profit
The accelerated approval process allows pharmaceutical companies to get their drugs to market based on what are called “surrogate markers”—essentially, educated guesses about a drug’s effectiveness.
Instead of proving that a drug actually helps patients live longer or improves their quality of life, companies can gain approval by showing that their drug shrinks tumors or slows their growth.
It sounds reasonable on the surface. After all, isn’t shrinking tumors a good thing?
But here’s the catch: growing evidence suggests that these surrogate markers don’t necessarily translate to what really matters—helping patients live longer, better lives.
The Broken Promise of Follow-Up Studies
Now, you might be thinking, “Surely they follow up to make sure these drugs actually work, right?” Well, that’s the idea. Pharmaceutical companies promise to conduct confirmatory trials after approval to prove their drugs’ real-world effectiveness. But here’s where things get murky.
A recent study found that a staggering 57 percent of cancer drug indications granted accelerated approvals between 2013 and 2017 failed to demonstrate a clinical benefit after at least 5 years of follow-up.
Even more concerning, 22 percent of these approvals were withdrawn entirely. That’s right—drugs that made it to market, were prescribed to patients, and generated profits for pharmaceutical companies, ultimately proved ineffective or unsafe.
The Illusion of Progress
What’s truly alarming is how common this fast-track process has become. It’s no longer the exception; it’s increasingly the rule. And why wouldn’t it be? For pharmaceutical companies, it’s a dream come true. They can get their drugs to market faster, start profiting sooner, and worry about proving real effectiveness later—if at all.
Dr. Bishal Gyawali, an associate professor from Queen’s University, puts it bluntly: “The accelerated approval system does not always work very well.” Confirmatory trials can take years to conduct, and when manufacturers do complete them, the drugs often fail to demonstrate a clinical benefit.
Even more troubling is the FDA’s apparent willingness to lower the bar even further. In recent years, seven oncology drugs have been converted from accelerated to full approvals based solely on overall response rate—a metric that looks only at tumor growth or shrinkage, without considering the drug’s toxicity or impact on patient quality of life.
Dr. Ian T.T. Liu of Harvard Medical School warns, “If you give a cancer drug to a patient with cancer and it poisons the cancer, but it is also poisoning the patient, you might be inducing tumor shrinkage, but it might not be at a cost that a patient would be willing to bear.”
The Price of Uncertainty
This rush to market leaves patients in a precarious position.
They’re often prescribed drugs without fully understanding the uncertainties surrounding their effectiveness. Dr. Edward Cliff, a hematology trainee, emphasizes the importance of communication: “Clinicians should communicate with patients about any residual uncertainty of clinical benefit when they offer novel therapies.”
But in a system where pharmaceutical profits are prioritized, how often does this crucial conversation actually happen?
The accelerated approval process for cancer drugs was created with good intentions—to get potentially life-saving treatments to patients faster. But in practice, it’s become a shortcut for pharmaceutical companies to profit from unproven drugs.
Until the system is reformed to prioritize patient outcomes over corporate profits, we must approach new cancer drugs with healthy skepticism.
Ask questions, demand evidence of real-world effectiveness, and remember that sometimes, the promise of a miracle cure might be too good to be true.
It’s time to demand change and hold both the FDA and Big Pharma accountable.
P.S. Instead of Big Pharma’s questionable drugs—wouldn’t you rather learn about safe, effective, powerful, natural therapies that are changing the future of cancer treatment? If this is you, click here to learn more about my Integrative Cancer Rescue Protocol.
Source:
Davenport, L. (2024). Accelerated Approval Pathway for Cancer Drugs: Does It Work? Medscape Oncology. https://www.medscape.com/viewarticle/accelerated-approval-pathway-cancer-drugs-does-it-work-2024a1000djy
