Sunday, October 4, 2009

Review and Corrections: Previous Post on Flu Vacines (Sept. 23)

Warning to regular readers-- this is a very long post and is only peripherally related to the main theme of this blog. However it is also an important post as it deals with questions about the accuracy of a previous statement made here, and raises questions of what is the most suitable way to correct any such inaccuracies. I do want it to be known that I try to take very seriously my obligation to provide accurate information here and to cross-check facts before posting.

Since I posted my comment on Sept. 23, regarding the article on flu vaccines by Dr. Juan Gervas on the Healthy Skepticism (HS) website, I have been in nearly continuous contact with Dr. Peter Mansfield, the Australian GP who's director of HS. Dr. Mansfield has been concerned about inaccuracies in my post and has been trying to persuade me to approach them in the way that he has specified, for various reasons having to do with HS's, my, and Dr. Gervas's reputation. I made two counteroffers which seemed to me to be quite reasonable. First, I expected that anyone who disagreed with the content of any of my posts (such as "Anonymous" did right away in this case) could simply do what "Anonymous" actually did do, and post a comment. I do not delete any comments from this blog unless they are commercial in nature or else completely vulgar and irresponsible. Second, when Dr. Mansfield elected not to post a comment, the very high regard in which I hold him and HS prompted me to offer to publish a post of his own composition in which he explained all the inaccuracies that he thought to be present in my original post. Again, for reasons too complex to review here, he chose not to do that either, except as a very last resort.

Dr. Mansfield continued to insist that the only satisfactory way to deal with this would be for me, first, to go over Dr. Gervas's original article sentence by sentence and explain any disagreements that I had with it, documenting each; and next, that I do the same thing subsequently with my own post. To which I replied that this might indeed be an ideal exercise but that I did not have time to do that. Unfortunately the amount of time I have subsequently taken in discussing this back and forth with Dr. Mansfield has now been several times what it would have taken me to do what he asked up front. So, as a compromise, I will here do a passage-by-passage re-analysis of my own post of Sept. 23. I am aided in this process by a message Dr. Mansfield sent me in which he offered his own such analysis. (As I said, that is what I offered to print verbatim, with an explanatory introduction, but that he requested that I not).

What follows is the original post with my later comments in bold italics.

Unhealthy Skepticism about Flu Immunizations
Healthy Skepticism is a website that I have been proud to be a member of and that assisted me greatly in all of my research. I am a member of HS and also of a listserv that includes HS members and generally find it highly informative. So it pains me to have to dissociate myself from a recent thread on that listserv and website that I believe to be quite wrong.

Dr. Mansfield notes that I am not "associated" with the article by Dr. Gervas, as it was clearly written by him and is not an official statement of HS as an organization, so there is no need to "dissociate" myself from it. However, others have fallen into the same trap that I did in assuming that the prominence that the article received (being translated into six languages for example) suggested some degree of HS endosement of the statement. I will address the HS listserv issue below.

I am taking this public stance because I think the issue holds lessons for us Pharmascolds, in terms of how we can go too far in our opposition to the bad practices of the pharmaceutical industry.

Dr. Mansfield here takes issue with my characterization of Dr. Gervas's article and notes that Dr. Gervas does not "go too far" or complain about misdeeds of Pharma. However my own language was very careful. I did not say Dr. Gervas said these things. I said that the issue raises these concerns in a general way. In effect I said that Dr. Gervas's article offers a teachable moment to address these issues of general concern. (Why of general concern I'll explain later as well.)

My concern is with a piece posted on the HS site, "In the Face of Swine Flu, Common Sense and Science": author is a Spanish GP who also holds a couple of academic posts. As a family physician I have been on the receiving end of attacks due to having dared to speak out on medical issues, when the relevant subspecialists thought that only they were entitled to express opinions. So I might have been expected to immediately identify with the author.

It was unkind of me not to mention Dr. Juan Gervas by name in this part of the post, though of course I did offer the direct link to his article.

The basic thrust of the piece is that swine flu is an example of "disease mongering"; that the vaccine is unnecessary because the disease is very mild; the vaccine has been rushed into production and so cannot be known to be safe; and anyway, the seasonal flu vaccine has been overpromoted and is not really scientifically shown to be of benefit.

Dr. Mansfield has pointed out to me that here I have been guilty of smooshing together what Dr. Gervas said in this specific article and what he had said elsewhere on the HS listserv. The agreement about this listserv is that what goes on there stays there unless we ask explicit permission to reprint something. So it was out of line for me to use the words "disease mongering," and I apologize for that. Dr. Gervas, interestingly enough, is not blaming the drug industry for any disease mongering or overselling of vaccines and antivirals; he is rather pointing the finger at WHO and national public health authorities. On that point I should have been more accurate in characterizing his position. Dr. Mansfield takes issue with several other points in my brief summary of what Dr. Gervas said. I invite any reader to go to Dr. Gervas's article and form your own opinion of the relative accuracy or inaccuracy of my summary.

Let me separate my reactions into two parts--seasonal flu and swine flu.I have followed the literature for many years on the health benefits of seasonal flu vaccines. (I personally always get my flu shot each fall, even though I am not now doing direct patient care.) I have been impressed with the nearly uniform showing in all studies that flu vaccines are highly beneficial and highly cost-effective. Indeed it is one of the most cost-effective preventive interventions available to us.

Dr. Mansfield disagrees and wants to know why I did not offer evidence in support of my assertions here. He particularly questions the claim that flu vaccine for healthy adults is cost-effective. I went back and looked at two sources-- Cochrane reviews of the effectiveness of flu vaccines; and articles included in Rick Bukata and Jerry Hoffman's "Primary Care Medical Abstracts" over the past 5 years. Without spending a lot of time here on this blog, which is not about seasonal flu vaccines, I think a case can be made that the seasonal flu vaccine is cost-effective for higher-risk patients, and less so, but still of value, for lower-risk patients. The dispute seems mostly to be over the quality of the studies, as there are many observational studies rather than randomized trials in the mix. On the other side of the coin is the undeniable fact that a flu shot is 1) incredibly safe and 2) very cheap. That means that for it to be cost-effective requires that a relatively low threshold of evidence be met. I would agree with both Dr. Mansfield and the Cochrane people that ideally, studies of better quality would be done in the future.

So trying to cast doubt on the wisdom of a swine flu vaccine by attacking the benefits of the regular seasonal vaccine seems completely wrong-headed.

Dr. Mansfield regards this statement as not reasonable because it is "vague and abusive." I do not think it is an inaccurate characterization of Dr. Gervas's argument. Again the reader can read both and decide.

As to the swine flu, we charge the public health authorities with preparing a vaccine each year that will protect us from the dominant strain of flu that is going to appear in the fall. This year, the appearance of a novel strain of H1N1 flu (swine) created great concern because most Americans under age 60 have never been exposed to a similar flu virus, so natural immunity was thought to be very low. And indeed, at this time in the U.S., there are near-epidemic levels of flu, very unusual for this early in the fall, and more than 90 percent of it is H1N1 (though when they started making the vaccine, no one could have known this would necessarily happen). Every year the task of making the flu vaccine with the correct strains of antigen is a crap shoot and any year you could guess wrong.

Dr. Mansfield thought this statement generally correct, but did not see it as being at odds with the general tenor of Dr. Gervas's piece. Frankly I am puzzled. I take Dr. Gervas to be saying in part that because the H1N1 flu is such a mild disease, calls for massive use of a vaccine against it are inappropriate. So what I say here seems at least somewhat contrary to the tenor of his thought. In recent weeks additional evidence of the severity of H1N1 in the US, especially among pregnant women (though again, strict comparisons with the mortality due to seasonal flu should be kept in mind), has come forward. I put that aside as no such evidence was available to Dr. Gervas at the time he wrote his article. Also I am focusing on events in the US whereas he would naturally be more concerned about what is happening in Spain, which might be quite different. (I have not researched that.)

The swine flu is being manufactured using the same techniques as used for the seasonal flu, which has an excellent safety track record ever since 1976, the year of the last swine flu scare.

Dr. Mansfield says this statement is inaccurate and mentions such things as the adjuvant added in some countries. I am again guilty of speaking to the US situation rather than the international situation, and I regret that narrowness of vision. I stand by what I say as accurate for the US. I should mention that our bioethics group has recently been asked to prepare a report on the ethics of allocating flu vaccines for the state of Texas, so I have been paying more attention than usual to the vaccine issue and also consulting with some vaccine experts locally. I realize now that I should mention this as a potential conflict of interest as our group is to be paid by the state department of health for our report.

In short I see no reason whatever to interpret anything related to swine flu vaccination as a public health response, as somehow related to disease mongering by the pharmaceutical industry or its allies or shills.

Ditto as above-- this relates more to what was on the HS listserv than what was in Dr. Gervas's article and I should not have used those terms. Plus, again, Dr. Gervas does not point a finger at the industry.

Now, where the author of the HS piece questions the use of antivirals, I think he is on firmer ground. Antivirals for flu have in the past been significantly overpromoted.

No serious dispute here.

The HS piece ends with this language:"Note: The only purpose of the author is to transmit the best knowledge about the problem at present, and for that he has reviewed the world literature. This text is an informative one, not for clinical use. Sadly, the information you can obtain from others sources (public organizations, scientific societies, media) is very different; they will know why."This appears to be a gratuitous ad hominem attack on anyone who disagrees with this author's conclusions, and seems utterly uncalled for.

Dr. Mansfield notes one again that it is not an "HS piece" but Dr. Gervas's piece published by HS; and he views my condemnation of the language as "unreasonable." Here I stand fully by my original statement. I found this an offensive and unnecessary ad hominem suggestion that the motives of others might be less pure than his own. My friend the vaccine expert similarly singled this passage out from the rest of the article as an uncalled for affront.

I may add that I checked into a couple of the authors' citations, and was impressed that the conclusions reached by those articles did not square with the conclusions offered in the HS piece.

Dr. Mansfield notes that this is inaccurate because there were NO citations as such in Dr. Gervas's piece. That is true and I apologize for my inaccurate characterization. His list of references was a bibliography, not citations. However, I did look at two of the references listed, that seemed pertinent to his arguments, and did not find as much support for his arguments therein as I would have guessed from his article.

So why do I make a big deal of my personal disagreement with this particular piece of writing (one that HS was apparently proud enough of, to have translated into several languages for dissemination)? Again, I need to beware attributing motives to others. But we have to be very cautious that our distrust of the drug industry and its many devious and dishonest practices, and of our physician colleagues who eagerly do the industry's bidding, not spill over into areas where it does not belong. When we decide that any product manufactured by the drug industry is therefore unsafe or unneeded; or that any effort to raise public concern about a disease is therefore commercialized disease-mongering, then I think we have clearly crossed over that line.

Again, Dr. Mansfield states that nowhere did Dr. Gervas actually commit any of these offenses. I would again say that my intent was to raise the issue and use his article as a teachable moment, not to claim that he had personally done these things. I was influenced in so doing by having read a recent article by Melissa Healy in the Los Angeles Times, on why parents in California were reluctant to have their children get the H1N1 vaccine. Distrust of the drug industry was one of the reasons given. Where does that leave people like me who arguably help to spread distrust of the drug industry? I certainly share Dr. Gervas's hopes that H1N1 will turn out to be mild and we will see our vaccination efforts in hindsight as excessive. But if children die in California because of an attitude that I helped to spread, then I worry about the misapplication of what people like me (even if not like Dr. Gervas) say. (Dr. Gervas did, however, say very clearly that the vaccine was experimental and untested and that the disease itself was very mild--so any parent reading his article would be inclined not to want his/her child vaccinated.)

I do want to stress that Dr. Gervas is no doubt better read than I on the subject of flu and flu vaccines, so he may well be correct and I incorrect. I am delighted that HS published his piece so that we could all double check on the degree to which recommendations are evidence-based.

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