ARTICLE: "FDA APPROVES NEW CANCER DRUGS DESPITE BAD SCIENCE"

FDA APPROVES NEW CANCER DRUGS DESPITE BAD SCIENCE

By Ty Bollinger

from The Truth About Cancer web site

Below is an excerpt from the article.  To read the article in its entirety click HERE.

ARTICLE EXCERPT: 

"Over the last 5 years, the FDA has approved nearly 150 new anticancer drugs. And although this may seem like good news, cancer patients may want to hold their applause. As it turns out, a significant portion of these approvals – nearly 1 in 5 – were based on clinical trials that don’t prove the effectiveness of the drugs.

A study published last month in JAMA Oncology evaluated 143 cancer drugs approved by the FDA between 2013 and 2018. 

Analysts found that 17% used “suboptimal control arms” and show no benefit over standard therapies. In other words, many anticancer drugs approved by the FDA haven’t shown any real benefit to patients. 

The FDA Drug Approval Process   

To better understand the implications of the new analysis, it’s important that we first understand the process for drug approval. 

Most drugs seeking FDA approval undergo something called randomized clinical trials to prove their efficacy. This means that participants are separated randomly into different groups to compare the effects of different drugs. 

In a randomized clinical trial, the group that does not receive the experimental treatment is called the control arm. The control arm may receive no treatment, a placebo, or the accepted standard of care. 

But what happens when new drugs are tested against inferior therapies? Or therapies that are rarely used? This is called a “suboptimal” control arm, and it essentially nullifies any findings of the study. When the control arm is suboptimal, there is no scientific evidence that the new drug offers any benefit over the standard-of-care.  

What this means is that the FDA is regularly approving new anticancer drugs that may not be any better than the standard drugs already in use. But whenever a new drug is approved, company stock goes up and people get paid. And as long as the new drug outperforms the control arm, it’s off to market."

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