Friday 24 May 2019

You Can’t Suppress the Data

As we are all learning, if you try and suppress research data, you’re ultimately going to fail. Especially if you’ve previously made such data available to the U.S. Food and Drug Administration, or even discuss the data in an email. Companies need to be ready to come clean with even negative data about their products, because only the complete picture will be considered by the people prescribed your product.

A company has to make a decision — forfeit some profit in the short-term and acknowledge their drug isn’t the best thing since sliced bread, or forfeit lots of reputation, trust and brand value in the long-term by trying to suppress negative data. If your sales team is driving brand strategy, you’re going to lose the value and trust built up in your brand every time.

Look at what Johnson & Johnson (parent company of McNeil, the makers of Tylenol) did when the Tylenol scare took place in the early 1980s. They didn’t try and cover up the fact that some of their product bottles were tampered with and led to some people’s deaths. No, they looked at the long-term value and trust in their brand and recognized that if they tried to act as though everything were okay, ultimately people’s trust in their brand would evaporate. They did the right thing and recalled every Tylenol product out there — 31 million bottles.

When it comes to health and mental health, trust is everything. If a client trusts their psychotherapist to act in the client’s best interests, then they build a positive, therapeutic relationship that ultimately benefits the client.

The same is true with medications. I trust Tylenol because the actions of the maker of Tylenol showed that here’s a company that “gets it.” They value my trust and business more than a short-term loss of profit due to a product recall.

While I was away this past week, Study 15 was on the front page of The Washington Post. What is Study 15? A study conducted in the 1990s by AstraZeneca for its atypical antipsychotic drug, Seroquel. The study was never published, but was considered by the U.S. Food and Drug Administration in its regulatory approval of Seroquel in 1997.

AstraZeneca, for its part, defends not publishing Study 15, because too many people dropped out of the study. Out of the 301 people initially enrolled in the study, 239 of them withdrew or dropped out, mostly because they experienced a relapse. Fewer subjects relapsed in the placebo group than in any of the Seroquel groups.

Obviously such data are valuable and can be interpreted appropriately — on average, 82% of people taking Seroquel dropped out of the study. This is the same percentage, as The Washington Post notes, that a later federally-funded study also found when looking at Seroquel.

We hope this serves as a lesson for future data and future companies.

Read the full article: A Silenced Drug Study Creates An Uproar.

Read Dr. Carlat’s take on it.

Read CL Psych’s take on it.



from World of Psychology http://bit.ly/2JBYUdd
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