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New breast cancer drugs approved by NICE – but where is the evidence?

Today, Britain’s NICE has recommended two new breast cancer drugs for routine funding. In a press release, NICE explained that:

“There are around 45,000 new diagnosis of breast cancer each year in England and it is estimated that around 8,000 of these people would be eligible for treatment with either palbociclib or ribociclib.”

However, the full benefits and harms of the new drugs are not publicly known.

Research shows that summary results typically provide a fuller picture of the negative side effects of drugs than journal articles do. According to World Health Organization standards, every clinical trial has to post a summary of its results on a public database within a year of trial completion.

Yet, trial results for neither drug have been consistently posted:

  • Out of 28 completed trials of Pfizer’s palbociclib listed on, only 5 have posted summary results. Out of the 23 trials lacking results, 21 seem to have been completed more than a year ago.

  • The same database lists five completed trials of ribociclib, which is being marketed by Novartis. Again, summary results seem to be overdue for two of these trials.

Today’s recommendation is likely to be good news for cancer patients in Britain. NICE is recognized as a leader in drug assessment worldwide, lending its recommendations considerable scientific weight. Also, NICE itself has called for more transparency in medical research, indicating that it has nothing to hide.

"Researchers at NICE have told us that they are forced to spend some of their time chasing down data and fighting legal battles to get it when they would prefer to be focused on analysing the evidence and writing guidelines."

Apparently, many pharmaceutical companies prefer not to share the full results of their trials. Cancer patients deserve better.

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