Morning sickness drug gains FDA approval despite alarming missing data in clinical trial

According to the CBC, an unpublished clinical trial is missing data for a third of its participants. The drug tested in the study has been prescribed for nausea in pregnancy for four decades, but its efficacy is in question. Dr. Nav Persaud thinks data from the trial should not be used because of a high risk of bias. In Canada the drug is sold under the name Diclectin and in the US it is called Diclegis. Persaud, a family physician and researcher at St. Michael’s Hospital in Toronto, has now published the flawed study, and is quoted at the Canadian Broadcasting Corporation website:

“If data for 31 per cent of the participants is missing, that’s a very big problem. The reason for that is if you don’t know what happened to those 31 per cent of women then you don’t really know about the effects of the medication so depending on what happened to those [participants], the results and the conclusions could be very different. This example shows why it’s important for the clinical trial information to be available to the public and it’s disappointing that it hasn’t been for more than 40 years.

“There might be other medications that were approved a long time ago based on older studies or even medications that were approved recently based on newer studies where the public availability of the clinical trial study reports would change our conclusions and change clinical practice so all of those reports should be made publicly available immediately.”

Dr. Persaud said he could not find a study that showed the medication’s effectiveness, after reviewing thousands of pages obtained via information requests to the FDA and Health Canada. Canada’s Society of Obstetricians and Gynecologists recommends ginger and vitamin B6 to relieve nausea and vomiting during pregnancy.

Not an isolated incident

The National Institutes of Health published an analysis of fraud in clinical trials, and it is both eye-opening and unsettling. The report suggests that if data fraud is not commonly detected, by analogy of ‘the tip of the iceberg,’ the actual rate may be rather high, with numerous surveys of scientists showing the majority have committed or know of misconduct. Further mentioned is that “More than 2000 scientific articles have been retracted over the last 40 years,” most due to data fraud, and that retractions have dramatically increased in recent years. (RELATED: Read more accounts of fake science at FakeScience.news)

In February 2015, Medical News Today noted that after clinical trial site inspections, the FDA took action regarding 57 clinical trials between 1998 and 2013, including 22 trial cites that committed falsifications and “under-reporting of potential side-effects.” A freedom of information request by professor Charles Seife at New York University uncovered the violations, but his search of the medical literature revealed that the FDA failed to notify the public, and did not retract the published results of the studies. A search of the FDA clinical trial inspection database showed that almost 4% of the records (over 4,000 trials) contained the FDA’s most severe classification of official action indicated. An example: failure to mention a leg amputation two weeks after an experimental treatment was started that was credited for “major clinical improvements.”

Who can you trust?

We use clinical studies to find medicines that are safe and effective. Big Pharma spends hundreds of millions of dollars to get a single drug approved, and the public relies on the integrity of this process. But people are corruptible; this is simply part of the human condition. Some research is conducted by those who are willing to falsify data. Thus what passes for science may in part be junk science. To elevate science to an exalted position, as if scientists are all-knowing, infallible, and beyond reproach, is a gross error of judgement. (RELATED: Read more examples of corruption in medicine and government at Corruption.news.)

Sources:

CBC.ca

NCBI.NLM.NIH.gov

MedicalNewsToday.com