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Dennis Lendrem
Dennis Lendrem
MSc in Medical Statistics, PhD from Oxford. Background in Pharmaceutical R&D. Contributor to popular magazines and trade magazines including Scrip Magazine, New Scientist and the Economist. Formerly Editor of the journal Pharmaceutical Statistics.
 
Posted in Business / Industries / Pharmaceuticals

Reporting Cancer Studies - Hopes and Fears

Apr. 11, 2012 4:14 pm

HealthDay has already received plenty of stick for its coverage of the HER2-based peptide vaccine AE37 - see the Health News Review. In truth, I thought it was one of the more balanced pieces of journalism that I've seen.

To cut a long story short preliminary data in a study of 217 breast cancer survivors suggest the vaccine triggers an immune response. Immune responses were observed in 86% of women receiving the vaccine compared to 27% in controls.

Until the vaccine is linked to an actual survival benefit or improvement in tumor status, no one can say if it helps breast cancer patients in a meaningful way.

But until the vaccine is linked to an actual survival benefit or improvement in tumor status, no one can say if it helps breast cancer patients in a meaningful way.

The study is a phase 2 study, meant to evaluate the vaccine's effectiveness and any side effects. Phase 3 studies are needed before the vaccine can be approved.

And attrition rates in the pharmaceutical industry are high - even after successful phase 2 studies there is still less than a 50% chance of making it to market with a safe and effective treatment.

Whether the reported immune response will translate into a meaningful improvement in survival remains to be seen. In their defence, the journalist placed a realistic 5 years on the earliest available treatment if it is approved.

But one of the sensitivities in reporting cancer studies is the hopes and expectations raised in patients. It is difficult to capture the quiet desperation of the recently diagnosed cancer patient.

Don't mess with people's lives.

If consumers hear or see stories that say a new drug “may be approved” or “could/should be approved” or “could be on the market” in some near time frame, they shouldn’t put too much stock in that prediction. The drug may never be approved and may never be available.
www.healthnewsreview.org
 
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