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What are the Odds of a Cancer Drug Actually Being a Breakthrough?


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11/2/2015
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The words “miracle, game changer, marvel, cure, lifesaver” are used indiscriminately to describe new cancer drugs.

The hype can created false optimism in patients struggling with cancer.

An oncologist searched the internet for recent news articles about cancer treatment and found that half of the drugs dubbed with superlatives hadn’t been approved by the Food and Drug Administration as safe and effective.

The FDA approves a drug if the benefits of taking it outweigh the risks. If a drug doesn’t get FDA approval, it can’t go to market. However, even if a drug gets approved, that doesn’t mean it is going to work on everyone who takes it.

Particularly concerning was that 14% of the drugs were praised without ever having been tested on human beings.

The hype can make oncologists feel like dream crushers. According to oncologists about one a month, a patient walks in with a question about a so called breakthrough or revolutionary drug he has read about online. The patient asks if the drug can help him and then the oncologist has to explain.

Oncologists want to foster reasonable optimism but the hype the builds false optimism can breed cynicism among those who study cancer.

If researchers who pursue developing new drugs pat themselves on the back and hail every baby step achieved as a miracle, it is possible that the sight of the ultimate goal is lost.

Last week researchers wrote in the journal JAMA Internal Medicine that the word “breakthrough” led readers to assume a drug was more effective and supported by more evidence than it really was.

Breakthrough is used by the FDA to describe a drug that treats a serious illness and based on preliminary evidence may demonstrate a substantial improvement compared with other avialble options.

There are very few drugs that deserve to be called breakthroughs. For example, imatinib or Gleevec is one. This drug turns off enzymes in one type of leukemia. A 2011 study reported that when treated with imatinib for 2 years, patients’ survival rates were as good as people without leukemia.

Read the source article here.

 



Category: Misdiagnosis and Failure to Diagnose

Gerry Oginski
NY Medical Malpractice & Personal Injury Trial Lawyer

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