On June 11, 2009, Dr. Margaret Chan, the director general of the World Health Organization (WHO), declared that the H1N1 flu that was then spreading around the world was an official pandemic. This triggered a series of built-in responses in many countries, including stockpiling anti-viral medications and preparing for a mass H1N1 vaccination program.
At the time the flu was still in its “first wave” and the fear was that subsequent waves, as the virus swept around the world, would become more virulent and/or contagious –- similar to what happened in the 1918 pandemic. This did not happen. At least our worst fears were not realized. The H1N1 pandemic, while serious, simmered through the winter of 2009-2010, producing a less than average flu season, although with some worrisome difference.
The Centers for Disease Control (CDC) estimates:
- CDC estimates that between 43 million and 89 million cases of 2009 H1N1 occurred between April 2009 and April 10, 2010. The mid-level in this range is about 61 million people infected with 2009 H1N1.
- CDC estimates that between about 195,000 and 403,000 H1N1-related hospitalizations occurred between April 2009 and April 10, 2010. The mid-level in this range is about 274,000 2009 H1N1-related hospitalizations.
- CDC estimates that between about 8,870 and 18,300 2009 H1N1-related deaths occurred between April 2009 and April 10, 2010. The mid-level in this range is about 12,470 2009 H1N1-related deaths.
The regular flu season kills about 30,000 Americans every year, and about 250,000 to 500,000 worldwide (according to WHO estimates). H1N1 was not as bad as the seasonal flu from pure numbers, but while the seasonal flu kills mainly the elderly, H1N1 had a higher fatality among young adults, pregnant women, and children (partly because older adults were partially protected from flu epidemics earlier in the 20th century).
Interestingly, experts expected the H1N1 pandemic to be in addition to the regular seasonal flu, but the seasonal flu did not show up this year. There were essentially no cases of seasonal flu. There is still no clear answer as to why, and it will probably take a couple of years to sort that out.
The low numbers for H1N1 left much of the public with the perception that the pandemic was a bit of a fizzle, and perhaps the WHO, CDC, and other national centers overreacted. This is more than just a bit of Monday morning quarterbacking, however. But the disconnect has led to questions about the decisions made by the WHO and also to the question of whether or not their decision making was free of conflicts of interest.
A report in the British Medical Journal (BMJ) last week by features editor Deborah Cohen and investigative journalist Phillip Carter has raised the accusation that the WHO did not handle potential conflicts of interest adequately when dealing with H1N1. This has set off a fresh round of criticism, leading at the extreme end to accusations of a deliberate conspiracy on the part of the pharmaceutical industry.
Several legitimate questions are now being raised (although I must point out that raising a question does not equal guilt, unless you are engaged in a witch hunt). Was the decision by the WHO to declare H1N1 2009 a pandemic justified? Were there any real conflicts of interest among the experts the WHO relied upon? Did the WHO adequately disclose potential conflicts of interest?
Decision to Declare a Pandemic
The WHO actually began its flu pandemic preparedness plans in 1999, when it stated:
“It is impossible to anticipate when a pandemic might occur. Should a true influenza pandemic virus again appear that behaved as in 1918, even taking into account the advances in medicine since then, unparalleled tolls of illness and death would be expected.”
This became the guiding principle of the WHO –- flu pandemics are inherently unpredictable, and potentially very serious. They also recognized that any effective action would have to be taken before the full scale of any pandemic was fully realized. Flu viruses have a tendency to mutate throughout an epidemic or pandemic, creating the potential for a virus to suddenly become more virulent. This has happened before, most significantly during the 1918 flu pandemic. But no one can know how bad an epidemic or pandemic will become until it is largely too late to do anything about it. Vaccines take several months, at least, to produce. And medication supplies also will run out quickly during a pandemic unless they are stockpiled.
The precautionary principle therefore holds –- prepare for the worst, even while hoping for the best. With H1N1 the pandemic was real and serious, with many deaths, and a higher proportion of deaths among the otherwise young and healthy. But the dreaded mutation to a more virulent strain never happened. There was also the unexpected no-show of the seasonal flu. There was no way for anyone to predict these outcomes.
It seems to me that it is irresponsible for politicians and leaders to scapegoat the WHO now because of their lack of a crystal ball. In attacking the WHO in order to seek political cover themselves they are perhaps making it more difficult for proper precautions to be taken the next time the world is threatened with a pandemic. Experts will be unwilling to stick their necks out if they will get them chopped off if their worst predictions are not realized.
This would be like suing a surgeon for malpractice every time they took out a healthy appendix. This would not be a good thing for future patients with possible appendicitis.
What will best serve the public interest is for world experts to think carefully about how to deal with potential pandemics, given the inherent uncertainties. We don’t want to declare a pandemic every flu season, but we also don’t want to be caught with our pants down. It’s a delicate balance, and it is perfectly reasonable to take a generally cautious approach –- meaning to declare more pandemics than will actually manifest as serious killers. The world would rather have a few false alarms than to be caught unprepared for another 1918 pandemic.
One specific point raised by critics is that the WHO changed their definition of pandemic for the 2009 H1N1 declaration –- removing the criterion that an epidemic must cause serious harm. The reason for this given by the WHO is that pandemics can become increasingly virulent but preparations cannot wait for that to happen. However, this opened the door for accusations of a conspiracy.
I must also point out that the dire predictions of the critics of the H1N1 vaccine also did not come to fruition. Remember the alarmist warnings about the flu vaccine and Guillain-Barre Syndrome (GBS)? As a result of these fears, the UK and US put in place a careful monitoring system. In the end there were no additional cases of GBS tied to the H1N1 vaccine –- no cases of vaccine-induced GBS.
Were There Conflicts of Interest?
The BMJ article raises concerns that many of the experts whose advice lead the WHO to declare a pandemic had undisclosed conflicts of interest. The question of conflicts of interest can be tricky –- it is somewhat of a judgment call and different people may have different opinions as to what constitutes a conflict. For this reason medical journals have largely moved to the policy of having authors disclose all potential conflicts and letting readers decide for themselves which are real conflicts.
This kind of policy should be a minimum for an organization like the WHO, but may not be sufficient. There needs to be an assurance that decisions are as free of conflicts as possible, not just disclosed.
But the real question is: What is a conflict of interest? There is a spectrum, and no place to draw a clear line of demarcation.
For example, if an expert is being paid a bribe or kickback in order to give an opinion that is favorable to a company, everyone is likely to agree that is an unambiguous conflict of interest. If an expert owns stock in a company whose profit is affected by the advice or decisions of that expert –- that is also a clear conflict of interest. And I think if an expert derives a significant portion of their income, or a large sum of money in any case, from a company, that produces a conflict. There are other similar clear conflicts –- any case in which the advice or decisions of an expert will directly affect their income or career.
But there is then a vast gray zone between these clear conflicts and having no industry ties at all. Academics and experts, precisely because they are experts, are often paid to give lectures, are consulted for their expertise, or are paid to design and conduct research for industry. While these are “ties to industry” they are not clear conflicts, because they do not necessarily create a situation where future advice or opinions given by experts with such ties will affect their own income or careers. These are often tenuous ties –- even being given a few hundred dollars to give a lecture is often characterized by critics has creating “ties to industry.”
In the case of the experts who advised the WHO on H1N1 the potential conflicts of interest are all of the gray zone variety. There have been no bribes or kickbacks, and no experts who stood to earn or lose money based upon their advice. But many of the experts were previously consulted by industry and some have conducted clinical trials for pharmaceutical companies who make vaccines or anti-virals.
This, of course, has not stopped the most shrill and hysterical critics to distort the situation. Mike Adams of Natural News, for example, falsely asserts that the BMJ exposed “kickbacks” and an actual conspiracy to defraud the public over the H1N1 pandemic (they reported nothing even close to this). If the e-mail I have been receiving over the last two weeks in any indication, the public’s perception of the situation is unfortunately closer to Adams’ distorted version than what the BMJ actually reported.
Just as with the Monday morning quarterbacking, there are potential harms that could flow from treating every tenuous industry connection as if it were a sinister conflict. The public benefits when the best experts in the field are advising both industry and regulatory and other government agencies. They help industry spend their research dollars most effectively. And they help governments make rational evidence-based policy decisions. Again we come to a matter of balance –- we want to allow experts to give the public the full benefit of their expertise, without creating real conflicts of interest which compromise their advice. I think the scientific community and governments are still working out how to achieve the optimal balance, and thoughtful reflection is therefore a good thing. But the basics appear to be covered.
This brings us to the final question –- where to draw the line between conflicts and non-conflicts may be tricky, but it is generally agreed that full disclosure and transparency is appropriate. This is where the WHO seems to have genuinely fallen down. Experts disclosed their potential conflicts to the WHO, but the WHO did not make them public. About this decision, Director Chan explains the purpose:
“is to protect the integrity and independence of the members while doing this critical work — but also to ensure transparency by publicly providing the names of the members as well as information about any interest declared by them at the appropriate time.”
That explanation is not compelling and comes off as tone deaf to the real concerns. Chan is essentially saying –- trust us, we will let you know what we think you need to know when we think you need to know it. This attitude just doesn’t cut it in the 21st century.
We can debate endlessly about the decision to declare the H1N1 2009 pandemic –- hindsight, as they say, is 20/20. But the decision was reasonable at the time. More importantly if in the future we find ourselves in the same situation with an impending flu pandemic, a similar response (perhaps there can be some useful tweaks) will be appropriate. Think about the alternatives –- would you rather have the world governments overprepare for a pandemic that never fully manifests, or would you rather have millions of preventable deaths because those governments were shying away from possible criticism?
The conversation about conflicts of interest needs to continue. It seems as if the pendulum has swung too far towards considering any industry connection a genuine conflict, making the issue more of a witch hunt than a reasonable precaution. It needs to swing back to a better balance –- so that the public can fully benefit from out best experts in important disciplines.
But in any case, there is no downside to full disclosure. True transparency is a starting point.
*This blog post was originally published at Science-Based Medicine*