Tuesday, April 7, 2009

Disclosure - Keep It Coming

Try to Avoid Taking Two Steps Forward and One Step Back
Slowly but surely, pharmaceutical companies are stepping up. Unfortunately, at times (too many times) it's been painful to watch the industry progress toward a more open and transparent orientation.

On the good news side, Pfizer announced that it is the first pharmaceutical company to be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). This helps to ensure the ethical treatment of clinical trial volunteers no matter where the research is conducted. The accreditation process is rigorous and took 15 months.

On the bad news side, this is 2009. Reports of unethical clinical trials have been popping up for decades. Indeed, Pfizer said that "AAHRPP accreditation is another step in Pfizer's ongoing efforts to earn public trust for integrity in research." So, why has this taken so long and why is Pfizer the only pharmaceutical company to mark the milestone so far? The AAHRPP has been awarding accreditation to programs since 2003.

This reminds me of the years that it has taken for pharmaceutical companies to post information about their clinical trials in public databases. Even after it was reported that a number of pharmaceutical companies were cherry-picking data from selected clinical trials that favored their investigational products, there was intense resistance to disclosing the existence of the previously unknown studies. Only after exposure in the news media and threats from Congress did the industry acquiesce. And still there's a steady flow of news about critical information being withheld here and there from the FDA.

There's just too much kicking and screaming, and it's not only about the progression toward more openness. Think of the history of the Medicare drug benefit, or instituting reforms on gifts and promotions.

The industry is full of smart, driven and ethical people, and they are supported by a lot of smart, driven and ethical consultants. I'm sure that they all recognize that the best way to run a business and to manage an issue is to move the information -- good or bad -- out quickly. More often than not, it's the tone and timing of the message that matters more than the severity of the issue. In practice, though, it's a different story. Of course, there are legitimate secrets and there are sometimes limits on what can be said. Still, we see companies (and governments and all manner of institutions) undermining their reputations by dribbling out crucial information over long periods of time.

There are lots of issues out there. Many companies are good at taking stock of their situations, writing extensive Q&A documents, developing "what if" scenarios and building advocacy networks to support their positions. But a lot of companies stumble on the next step -- getting out ahead of the issues. They're coming, you can see them. So, step over them, step around them, confront them head on, whatever. Just don't get run over again.

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