How You Can Help to Increase Integrity in Pharmaceutics

“Spin and bias exist in a high proportion of published studies of the outcomes and adverse side-effects of phase III clinical trials of breast cancer treatments…” Science Daily 

58% of the trials that showed the treatment to be ineffective in achieving the primary endpoint were published as if the results were positive. 67% of papers that reported adverse effects did so in a biased manner, severely under-reporting the more serious adverse events in efficacious treatments. Result? The peer-reviewed published data on breast cancer treatments accurately reflects neither the efficacy nor the risks of treatment.

What is worse is this observation does not only apply to breast cancer treatments. After all, Turner et al. published that, with regard to anti-depressants, the vast majority of the trials with positive results were published, but less than 10% of those with negative results saw the light of day. Moreover, about 30% of the trials with negative results were published as if they were positive. Definite spin and bias.

Then, take the case of Tamiflu, the anti-flu medication made by Roche and stockpiled at great expense to many governments. The British Medical Journal has pointed out  that, in fact, Tamiflu is no more effective against flu than Tylenol. But, since only half of the Tamiflu drug trials are published, the medical community and the public, not to mention the governments, are kept in the dark.

The inevitable result of this spin and bias is that physicians have difficulty discerning which treatments are beneficial to the patient and which are only beneficial to the pharmaceutical company. In addition, the public loses confidence in traditional medicine.

What can be done? Various organizations, including the FDA, the European Medicines Agency, and the International Committee of Medical Journal Editors have agreed and/or demanded that all trials, not just positive ones, be published. This has not been accomplished; only a fifth of FDA registered trials are published. But, it can be.

As a start, “the All Trials Initiative is calling for universities, ethics committees and medical bodies to enact a culture of change, ensuring that under-reporting of trials is recognized as misconduct.” You can help. Sign the petition here and make a stand for integrity in science and medicine.

Sorry, comments are closed for this post.

Read previous post:
Of Airplanes and World Views

Adapted from an article by James Keith Johnson In pilot training we learned that a small initial error at the...