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WHO, H1N1, and Conflicts of Interest

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 – 500,000 world wide (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 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 Guillaine 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.

Full Disclosure

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 does not cut it in the 21st century.

Conclusion:

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.

Posted in: Public Health

Leave a Comment (28) ↓

28 thoughts on “WHO, H1N1, and Conflicts of Interest

  1. jimpurdy says:

    Just a question … but should health and medical bloggers like yourself voluntarily make full disclosures of any conflicts of interest?

    jimpurdy1943@yahoo.com
    The 50 Best Health Blogs

  2. Jim – absolutely. We have, individually, and when relevant, made it clear that we have no potential conflicts of interest. But I have also added to the editor/contributor pages a general statement that SBM receives no industry funding. It is completely independent.

  3. aeauooo says:

    My initial reaction to the BMJ exposé was to wonder if the editors of that journal had considered the potentially severe consequences of their criticism of the WHO pandemic flu response, but this is not the first time that articles critical of the pandemic influenza plans or that have otherwise added fuel to the antivaccinationists’ fire have been published in BMJ.

    I found the language of the Cohen and Carter exposé (yes, I am using that term pejoratively) to be subjective and presumptuous. Rather than suggest that the WHO experts may have had a conflict of interest because of their relationships with the pharmaceutical industry, the authors refer to those potential conflicts of interest as if they had been proven by their allegations to be true.

    Cohen and Carter made no mention of the fact that despite the challenges to their efficacy, neuraminidase inhibitors are the only antivirals (to my knowledge, at least) that are active against most influenza viruses currently circulating; 2009 H1N1 is resistant to the amantadines.

    The WHO may have changed the definition of ‘pandemic influenza’ that they were using, but the “new” WHO definition is one that had been in use for at least five years prior to that change in medical journals, textbooks, and a Homeland Security guidelines signed by G.W. Bush.

    According the Cohen and Carter, an IOM review of WHO’s handling of the pandemic will be reported next year – presumably, after the 2010-2011 northern hemisphere influenza season.

  4. A great column. One thing to add: We lawys hate to see stories of hotels price-gouging people fleeing some natural-disaster zone, such as fleeing the gulf coast as a hurricane approaches. We also hate to see price-gouging for bottled water, or gasoline, once normal supplies are cut off due to a hurricane or some other short-term, crisis, unanticipated event.

    I believe that your discussion of the ways to deal with conflict of interst are not suited to such time-limited, unpredictable emergencies. In emergencies, there are populations of people who suddenly become vulnerable and needy.

    A different set of ethics is called for, in contrast to those called for as paid shills strive to publish yet another piece of pharma-sponsored research promoting some patented medication for some condition.

    Your discussion of ethics starts at the point that the involved decision-makers are ethical, and that there are NO unethical forces skulking around, striving to take advantage of a crisis.

    But there are.

    In the discussion above, I do not see a method for controlling the influence of the unscrupulous. In my opinion, “disclosure” is not enough. Because the willingness to comlpy with emergency vaccinations depends on a great deal of trust. Public health does not have this trust. Public health has blown it.

    Just as there are price-gougers following a hurricane, it is known that Big Pharma is in the mix.

    When I take off my academic cap, and put on my regular-person cap, I have no trouble seeing how a great portion of the general populace laughs and shrugs as all of the white-coated alarmists thrash about on like chicken little about H1N1, and so on. SARS. The ozone hole. Grilling hamburgers. And take your vitamins. The ever-kaleidoscopic food pyramid.

    We everyday people do not trust you because we know that, in your camp, there are the opportunists wiggling in to make a buck. We see it with every impending and realized disaster. We can think of too many cases where public health has called it wrongly.

    We think: If a bunch of deadly cases of the flu popped up in Mexico, then why not step up border security? Isn’t that one of the big reasons for having some control over who walks in to your country? To control spread of infection?

    As an everyday person, I am aware of the immunization standards that can be in place before I can enter another country. I am aware that I cannot bring back produce, and so on. Why? To have one of many ways to control the spread of disease. Hep B rates are high in Asian immigrants, illustrating this well-known issue.

    So, when H1N1 was such a big deal, but we refused to check the border more closely, people realized that this did not add up, and something fishy was going on.

    As an everyday person, I also am aware of the long history of stories of pharmaceuticals that are banned in the United States, for being dangerous by our standards, or not yet being approved here, being marketed, or even purchased and promoted by foreign governments for what we might call vulnerable populations, in other places on the globe.

    This was checked by laws, but became legal, under certain circumstances, in 1986…
    http://leda.law.harvard.edu/leda/data/99/gpierce.html

    Putting my academic cap back on, I believe that a different set of ethics is called for as the possibility of a deadly flu pandemic begins to emerge.

    We as professionals involved, in our various ways, in public health, need to become aware of the major efforts of the pharmaceutical companies to play major roles in commercial-vaccine endeavors across the globe.

    http://theflucase.com/index.php?option=com_content&view=article&id=2309%3Awho-adviser-conceals-a-donation-of-millions-from-a-pharmaceutical-company-&catid=41%3Ahighlighted-news&Itemid=105&lang=en

    What do we need to do?

    We need to be honest and acknowledge amongst ourselves that, to everyday people, our calm reassurances are not believeable. Once bitten, twice shy. It is hard to get the horse back in the stable. Tuskegee. Thalidomide. HRT. And so on.

    We need to operate in ways that acknowledges that public health officials are not trusted. The general public has tremendous reason to suspect the public health professional with a syringe in hand.

    In my opinion, the COI standards need to be very, very high. Otherwise, there is not trust from the public, and this distrust gets sustained by every emergent COI story added to every revelantion-of-unknown-harm, and every seemingly capricious change-of-opinion.

    Our criteria for what is needed to control an outbreak needs to have “trust/credibility” as the first item on the list. We have very little chance of actually controlling a more serious H1N1 type outbreak without trust.

    We as public health people need to have contact with everyday people in order to appreciate the lack of credibility.

  5. I agree that public health organizations need to jealously guard their credibility, and that transparency is critical to this, as well as rational management of conflicts of interest. And private industry need to be carefully monitored and smacked hard when they do truly unethical or deceptive things.

    But there is far more to this equation. There are ideologues, snake-oil salesmen, and just kooks who are cooking up conspiracy theories and distorting reality at every turn. They create a virtual no-win scenario for such agencies.

    There is also an appalling level of scientific illiteracy among the public. Understanding also leads to trust. One primary problem with public perception gets filed under – the perfect is the enemy of the good. The public seems to want perfection, and is intolerant of error. But this results in attacking and inhibiting imperfect but very good measures that are designed to protect the public.

    It is easy to criticize, but it is difficult to actually address complex problems. If you think the WHO’s response was sub-optimal, then come up with something better – something that does not involve the impossible like predicting the future.

  6. macleod57 says:

    The only thing I really worry about is “a boy who cried wolf” mentality developing about the WHO. Very few people understand a combination of erring on the side of caution and flat out luck which is what seems like happened with H1N1 in 2009. The next time the WHO labels a disease a pandemic I fear that many people and possibly several governments will simply ignore it with the mantra “They said the same thing about H1N1 in 2009!”.

  7. Rogue Medic says:

    In the video segment the narrator stated, Professor Arnold Monto produced a section on the need for and difficulties in producing vaccines.

    How are we supposed to find someone who might remotely qualify as an expert in the problems associated with the difficulties in producing vaccines, yet has no connections to vaccine companies?

    If we can find someone who claims to possess such expertise in the manufacture of vaccines, but claims to have no ties to vaccine companies, just how useful is that person likely to be?

  8. aeauooo says:

    macleod57,

    I’m afraid that we in public health are already facing a “boy who cried wolf” scenario that began with the concern over H5N1 five or six years ago.

    As Steve pointed out, the public has “an appalling level of scientific illiteracy.” Unfortunately, a substantial number of health care providers seem to be ignorant of the safety and efficacy of influenza vaccines. According to SteelFisher et al. (http://content.nejm.org/cgi/content/full/NEJMp1005102), “By December [2009], a quarter (24%) of adults had talked to a doctor or other health care professional about getting the H1N1 vaccine for themselves, and of those, 53% said the practitioner had recommended getting the vaccine, 17% said that the practitioner had recommended against it, and 30% said that the practitioner had made no recommendation either way.”

    This did not come as a surprise to me because we received anecdotal reports of people in some Louisiana Parishes that refused the 2009 H1N1 vaccine because their PCP had questioned the safety of the vaccine.

    SteelFisher et al. concluded, “Our review of these data suggests that in the event of a future influenza pandemic, a substantial proportion of the public may not take a newly developed vaccine because they may believe that the illness does not pose a serious health threat, because they (especially parents) may be concerned about the safety of the available vaccine, or both.”

  9. Todd W. says:

    I also recall hearing, though I don’t remember the source, that 2009 H1N1 A reached a pandemic level several weeks before the WHO declared it such. In other words, they held off a little due to the requirements that go along with a pandemic declaration (e.g., vaccination programs, stockpiling, etc.).

  10. Deetee says:

    Just to say that in the BMJ Cohen and Carter article responses, there are posts from Margaret Chan and Tom Jefferson.
    http://www.bmj.com/cgi/eletters/340/jun03_4/c2912

  11. aeauooo says:

    Deetee,

    Following the URL that you posted, my eyes fell on a response that began, “Following seeing my nephew regress into severe autism within days of receiving the MMR jab nearly 15 years ago…”

  12. SkepticalLawyer says:

    Great post.

    But I think that the public has a right to be worried about even the conflicts of interest that you say are in the “gray area.” If an expert has received even a few hundred dollars from a company for giving advice or a lecture, that expert might, consciously or subconsciously, be concerned with alienating the company and not receiving any future invitations to speak or provide advice.

    Lawyers have rules governing conflicts of interest with former clients. Generally, those rules prohibit a lawyer from representing another person against the former client where either the new dispute is related to the dispute for which the lawyer represented the former client, or where the lawyer might be able to take advantage of confidential information gained from representation of the former client. In short, only if the new dispute is totally unrelated to the old dispute may the lawyer represent someone against a former client.

    I think scientists should go by a similar rule. Yes, that would mean that a scientist who has advised a pharmaceutical company on vaccines should not be involved in deciding whether there should be a declaration of a pandemic where that declaration would increase the profits of the company for which he/she provided services.

    But that leads me to an important question: are there sufficient numbers of qualified experts who can remain entirely independent from any industry connection to provide a pool to make the policy decisions for governmental bodies? If not, then we may have to decide, as a matter of policy, that we must put up with some level of conflict of interest.

  13. SkepticalLawyer says:

    RogueMedic:

    Isn’t the difficulty in producing vaccines irrelevant to the question of whether the vaccines are needed? WHO should determine whether there is a pandemic and whether vaccines (and how many doses) are needed without any thought of the difficulties of producing the vaccines.

  14. BKsea says:

    One of the great challenges of dealing with a crisis is that the optimal response will always appear to be an overreaction. If the crisis is stopped in its tracks before significant harm is done, it will seem like not such a great crisis after all.

    One question I have is whether anyone has estimated the benefits from the worldwide response to H1N1. How many lives were saved by the aggressive vaccination campaigns? How many people sought lifesaving treatment earlier because of concerns over the virulence of the disease? To what extent did the public health campaigns reduce the likelihood that a more virulent strain would emerge?

  15. aeauooo says:

    SkepticalLawyer

    “Isn’t the difficulty in producing vaccines irrelevant to the question of whether the vaccines are needed?”

    Two points:

    1. Using the current manufacturing techniques, the production cycle (correct me if I’m wrong) roughly 6 months – from isolation of the reference virus to availability of the vaccine.

    2. As Steven already mentioned, the virulence of an influenza virus can change while it circulates. During its first pandemic wave, the 1918 H1N1 virus mainly caused mild disease. By its second wave, the 1918 virus had mutated to become highly virulent.

    How long into a pandemic should we wait before we decide whether or not the vaccine is needed?

  16. redundant says:

    Doesn’t conflict of interest also come out a little bit in the wash. With a response as big as the H1N1 required, I assume the decision was not based on the opinion of a couple of people. There were other countries involved, other organizations, medical groups. Again, it seems like it would require a vast conspiracy for the response to have been strictly a money making venture. An awful lot of people seemed to agree this was the approach.

    Secondly, and maybe here is where transparency is required; who are you going to ask? Experts are experts for a reason. They are the people who are researching the subject disease, both in acedamia and pharma, diagnosing disease, public health officials, etc. I don’t imagine there are many experts wrapped in cellophane doing nothing until torn open by someone wanting an unbiased, no conflict of interest opinion.

  17. daedalus2u says:

    Skeptical Lawyer, there is a gigantic difference between the legal and ethical obligations of a lawyer toward his/her client and the legal and ethical obligations of a scientist or health care professional toward a public institution setting public health policy.

    The primary duty of a lawyer is advocacy. The lawyer is ethically and legally obligated to do anything and everything within the law and within his/her power to zealously advance his/her client’s interests. A lawyer does have a conflict of interest in representing clients who have any degree of overlap in the areas of dispute.

    At trial, a lawyer has the obligation to put forward plausible ideas that the lawyer knows are factually inaccurate if those plausible ideas put doubt in the jury’s mind as to the guilt of the person the lawyer is defending. The lawyer isn’t allowed to lie, but is allowed (and required) to “expert shop” and “cherry pick” until he/she finds an “expert” that will tell the story the lawyer wants told for his/her client.

    A scientist does not have the obligation to zealously advance his/her client’s interests. The scientist’s obligation is to the “truth” as he/she understands it. The scientist’s obligation is to give as accurate and unbiased advice as is possible. It is never to put forward ideas known to be factually inaccurate. It is to never “cherry pick”.

    I think one of the problems with science literacy is that these differences between the duties of lawyers and scientists are deliberately obscured by lawyers because it is advantageous to their clients to do so. The lawyers pushing the vaccine litigation have an obligation to their clients to find “scientists” like Wakefield who will commit fraud and lie about vaccines. The lawyer just needs to be kept out of the loop so he/she has plausible deniability as to knowing there is fraud and lies being told.

  18. sheldon101 says:

    Surveillance reports at the time did not show increased cases of GBS. However:

    Perhaps one per million additional cases of GBS linked to H1N1 vaccine.

    Preliminary Results: Surveillance for Guillain-Barré Syndrome After Receipt of Influenza A (H1N1) 2009 Monovalent Vaccine — United States, 2009–2
    http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5921a3.htm

  19. BillyJoe says:

    Okay, WHO’s wrong here?

    “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.”

    I get 66 million.

    “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.”

    and 299,000

    “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.”

    and 13,585

    (They do say “mid-range” so they may mean something other than “the average”).

  20. aeauooo says:

    sheldon101,

    If you read mm5921, you know that 1 additional case of GBS per million influenza vaccine recipients is not a new estimate (The baseline incidence of GBS is 1 -2 cases per 100,000 population/year).

    You also read, “risk assessment should take into account that influenza and influenza-like illnesses are associated with significant morbidity and mortality, including a hospitalization rate of 222 per 1 million population and a death rate of 9.7 per 1 million population for H1N1-associated illness, as well as possible increased risk for GBS.”

    Influenza is one of the antecedent illnesses known to be associated with GBS. I would like to see an estimate of the number of cases of GBS prevented by influenza vaccines.

    BillyJoe,

    Generally, the term ‘mean’ is used in statistics rather than ‘average.’

    By “mid-range,” the CDC is apparently referring to the median values. Using median rather than mean tends to limit the influence of outliers.

    For example, Bill Gates is a resident of Seattle. Gate’s income is an outlier. Including Gate’s income in the mean income of residents of Seattle would result in an overestimate of the earnings of most Seattlites. Gate’s income would not have that effect on the median income of Seattle.

  21. Harriet Hall says:

    Re Guillain-Barre –
    GBS can occur as a reaction to an infection. What is the incidence of GBS in unvaccinated people who get influenza? Isn’t it possible that some post-infection cases of GBS might have been prevented because the vaccine prevented the disease?

  22. jsn says:

    aeauooo: It does also seem to run pretty close to the geometric mean, which makes sense, considering the spread is exponential in nature.

  23. BillyJoe says:

    aeauooo,

    Generally, the term ‘mean’ is used in statistics rather than ‘average’….By “mid-range,” the CDC is apparently referring to the median values. Using median rather than mean tends to limit the influence of outliers.

    Ah, that makes sense.

    But I wonder why they didn’t use the usual term?
    (And thanks, yes, I understand the reasoning behind the use of the term “mean value”, but good example with the Bill Gates thing)

  24. tryout says:

    re: Invocation of Precationary Principle to justify some less than ideal aspects of H1N1 Antivax approach

    I would like to respectfully point you to Bruce Schneier ‘s analysis of the significant problems with Worst Case thinking

    http://www.schneier.com/crypto-gram-1005.html#1

    Excerpt:
    “My nightmare scenario is that people keep talking about their nightmare scenarios.

    There’s a certain blindness that comes from worst-case thinking. An extension of the precautionary principle, it involves imagining the worst possible outcome and then acting as if it were a certainty. It substitutes imagination for thinking, speculation for risk analysis and fear for reason. It fosters powerlessness and vulnerability and magnifies social paralysis. And it makes us more vulnerable to the effects of terrorism. ”

    much more here
    http://www.schneier.com/crypto-gram-1005.html#1

  25. BillyJoe says:

    tryout,

    It depends on how bad the worse case scenario is and how simple the solution is.

  26. mariposa says:

    I am a pediatric nurse practitioner who believes in the preventive power of vaccines. It is June 2010 and our Children’s Hospital Infectious Disease dept is going to be holding some H1N1 free vaccine clinics over the next few weeks. When I asked the dept chair about the risk of the disease at this point, she said there are a few isolated cases in the southern US (which we aren’t located). Basically they were told by the CDC that they had allocated too much vaccine and that it was going to be more expensive for them to dispose of the vaccine than to give grants to institutions and schools to administer free vaccine. So that is what they did. The information that came to promote the vaccine would have one thinking we are still at great risk.

    YIKES!!!!! Suddenly my trust in the CDC and their information about the epidemic and vaccine is spiraling downward. I am not the public but a professional.
    There are GOOD reasons the public is mistrustful.

  27. aeauooo says:

    mariposa,

    Pandemic viruses replace the circulating seasonal influenza virus, so 2009 H1N1 is not going away.

    The 2010-2011 seasonal flu vaccine will include antigens of 2009 H1N1.

  28. michael0156 says:

    After downplaying WHO advisors conflicts of interest Novella reduces his argument to the very same fear mongering Pig pHarma rhetoric that emptied government health care coffers into the gaping maw of a few vaccine manufacturers…
    -
    Novella says “…the decision [to declare H1N1 pandemic] was reasonable, AT THE TIME [apparently no longer?]. …if we find ourselves with an impending flu pandemic , a similar response will be appropriate.”
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    But no one knows if a pandemic will occur, so we are ALWAYS faced with an “impending pandemic”, so Novella tells us no matter what, we always have to overprepare, overspend, & hand it all over to Pig pHarma
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    Novella continues – “Think about the alternatives – would you rather have the world governments overprepare for a pandemic that never fully manifests [pouring billions uselessly into Pig pHarma's coffers], or would you rather have millions of preventable deaths…?” No logic, no science… Nothing but fear, based on the scientific failure and impotence of Pig pHarma, the FDA, the CDC & the WHO
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    Which leads us to counting flu deaths, another lesson in fear mongering. Most deaths from flu are not from flu. People die from something else while they have, or are ASSUMED to have, flu. The deaths are “flu associated” but the CDC’s method of reporting leads us to believe these deaths are CAUSED by the flu.
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    To clarify “ASSUMED to have”… During the 2009 “pandemic” Virginia Department of Education meted out a directive through school commissioners that ALL absences were to be reported as swine flu regardless of the known or unknown cause.
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    How’s that for evidence of collusion between corporate Pig pHarma and our government? BEFORE the non-existent pandemic government officials put in place a directive passed to teachers and administrators to LIE about the numbers of flu associated absences.
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    This CLEARLY indicates the government of Virginia, or someone directing them, knew there was not going to be a pandemic, long before the pandemic didn’t happen, and was actively engaged in creating the appearance of a pandemic!!!!
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    In the 2008 flu season the 36,000 flu “associated” deaths hides the “fact” that only 20 deaths were directly blamed on the flu. How many of those direct “deaths by flu” were “mistakes” or happened because of compromised immunity caused by poor nutrition, toxic exposure or genetic defect?
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    Novella twists facts, downplays the effects and seriousness of conflicts of interest and continues to support Pig pHarma in everything he posts.
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    Novella is merely a Pig pHarma shill, his opinion is clearly bought and paid for, and his conflicts with truth are crystal.

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