It is hard to believe the World Health Organization (WHO) wouldn’t have put the highest priority on determining and implementing the best practices for demonstrating transparency and for managing conflicts of interest – real or perceived – with the pharmaceutical industry.
WHO is now responding to attacks on its credibility and reputation, primarily in Europe, over whether it handled appropriately conflict-of-interest issues with drug companies in the H1N1 pandemic, whether it exaggerated the pandemic, and why the organization isn’t more transparent. WHO officially launched the pandemic a year ago on June 11, 2009.
WHO operates within the United Nations system responsible for leadership on global health issues and setting research agendas. Not to have clear standards for conflicts of interest and operating transparently that meet the test of inevitable, and appropriate, scrutiny puts its larger mission at risk and is a failure of ethical leadership.
WHO hasn’t been oblivious to the criticism leveled at it for the last several months, but last week received a one-two punch by two European based reports: one from the Parliamentary Assembly of the Council of Europe (PACE) committee and from a joint investigation by the BMJ (formerly called British Medical Journal) and the Bureau of Investigative Journalism in London.
Recommendations in PACE’s Social, Health, and Family Affairs Committee report include calls for greater transparency and better governance in public health and safeguards to protect against “undue influence by vested interests,” suggesting a public fund be created to support independent research, trials, and expert advice financed by drug companies. The 47 Council of Europe member states will debate the report at their June 24 plenary meeting.
The investigative report published by BMJ covers many areas, but on the subject of conflict of interest, the authors write: “WHO also says it takes conflicts of interests seriously and has the mechanisms in place to deal with them. But what action does it take when a scientist declares a conflict of interest, and when does it judge a scientist to be too conflicted to play a leading role in the formulation of global health policy? Since WHO has not provided us with an answer to this question, we are left to guess.”
In response to BMJ’s report, WHO Director-General Dr. Margaret Chan, posted a letter this week on WHO’s website saying that conflicts of interest are inherent in any relationship between an organization like WHO and profit-driven industries. “WHO needs to establish, and enforce, stricter rules of engagement with industry, and we are doing so.” Dr. Chan wrote.
However, she goes on to say, “At no time, not for one second, did commercial interests enter my decision-making.” The problem with Dr. Chan’s going for the moral high ground here is three-fold. An organization that does not have a reputation for transparency is difficult to accord a moral high ground. Secondly, absent vigorous demonstration that conflicts of interest aren’t tolerated, words are empty. Thirdly, it has become harder and harder to see examples of altruism separated from financial gain, especially in the mix of drug companies and researchers.
In the U.S., concerns about conflict of interest and transparency in the financial relationships drug companies have with researchers drove passage of the Physician Payment Sunshine Act as part of health care reform legislation. Pharmaceutical and medical device companies have already begun voluntary reporting of royalties and consulting fees they’ve paid prior to the law’s 2013 implementation date.
Is anyone else reminded here of John le Carre’s novel The Constant Gardener, and the movie made from it?
It exposes a drug company’s abuse of influence in testing a drug with severe side effects on African children? “As my journey through the pharmaceutical jungle progressed, le Carre wrote in the book’s afterward, “I came to realise that, by comparison with the reality, my story was as tame as a holiday postcard.”
Dr. Chan’s letter says she recommended an independent review committee be charged with looking at how WHO handled the issues of the pandemic and the committee began work in April. Harvey Fineberg, President of the Institute of Medicine in Washington, D.C. is chairing the committee; Dr. Fineberg has said the purpose of the committee is to identify lessons for the future. If its report falls short of dealing effectively with all the issues critics have raised, WHO won’t be moving the needle very far in rebuilding credibility and trust.
WHO’s leadership in global health issues depends on how it safeguards its integrity by handling conflict of interest in a manner that is transparent and stands up to scrutiny. It cannot establish trust unless its information is trustworthy and communicated in a credible way. Without that, the next time it has evidence of a pandemic it could find itself fighting the battle of the Boy Who Cried Wolf.
Gael O’Brien, June 12, 2010