Monthly Archives: July 2011

Unhealthful News Hiatus

Hi, everyone.  I have completed a half year of daily Unhealthful News posts, but I am not going to finish the promised other half year.  Not immediately anyway.  I am also going to mostly go dark with regard to blogging in general, and perhaps other media.  I will try to look out for direct messages and will probably not be completely silent on twitter and facebook. 

To the health news reporters and the bad researchers and busybodies who are doing so much damage to public health, let me assure you that this does not come because I have discovered a shortage of unhealthful, unscientific, and unethical behavior to challenge.  In other words, it’s not you, it’s me.  I suspect most of my close followers have picked up on my professional frustrations and other difficulties.

I think I will probably be back, so see you then.

Unhealthful News 182 – Did Serious people seriously think FDA regulation of tobacco would go any differently than it has? Really?


Yesterday Paul Krugman summarized someone else’s comments as follows:

“Some people thought from the beginning that the stimulus should have been much bigger. Hahaha! Also, it turns out that the stimulus was too small, so we need some more.”

From this, he goes on to observe (a version of one of his points that may be as important has his economic theory):

This is actually a fairly familiar thing from my years as a pundit: the surest way to get branded as not Serious is to figure things out too soon. To be considered credible on politics you have to have considered Bush a great leader, and not realized until Katrina that he was a disaster; to be considered credible on national security you have to have supported the Iraq War, and not realized until 2005 that it was a terrible mistake; to be credible on economics you have to have regarded Greenspan as a great mind, and not become disillusioned until 2007 or maybe 2008.

Making the rounds lately is a piece from Tobacco Journal International by John Lauterbach, a nonvoting (industry) member of the US FDA’s Tobacco Products Scientific Advisory Committee.  In it he observes:

Congress did not intend to forbid adult use of legally manufactured and marketed tobacco products. Indeed, Congress gave the FDA (Food and Drug Adminstration) the authority to make sure that tobacco products were made under good manufacturing practices using tobaccos and ingredients that were free from contamination, and that such products were not adulterated and/or misbranded.  …. Moreover, users of tobacco products would be given accurate information on which classes of tobacco products presented higher health risks to the user than did other classes of tobacco products. Furthermore, there would be active support by the FDA for reduced risk tobacco products.  Finally, the CTP staff would include scientists and engineers who were as knowledgeable in the design and production of tobacco products as were their counterparts in industry, and there would be joint research on test methods for the characterisation of tobacco products and tobacco smoke.

Um yeah.  It is not clear whether he really believes this, or if it is just a setup.  If he does believe it, he seems to join a lot of others in qualifying as Serious, in the Krugman sense.  He does take a tone of genuine surprise when he continues with:

So, why have the good outcomes that would lead to reduced tobacco-related disease not happened?  Apparently, Dr. Deyton and others at the CTP and the FDA do not want them to happen. It appears that they want to continue the scourge of tobacco-related disease in the hopes that the populace will demand the elimination of the tobacco industry and tobacco use.

Hmm.  Where have I heard that before?  Oh yeah, that is how I have been characterizing this political faction for about five years, having coined, defined, and characterized the term “anti-tobacco extremists” because I was sick of hearing them erroneously referred to as “public health”.  It is what I predicted would be the outcome of FDA regulation when it was in the works.  This was at a time when many others who are interested in tobacco harm reduction, as well as the industry, were optimistic about how it would go.  It sounds a lot like what I was still pointing out a year and a half ago to anyone who would listen.  I never changed my position, by the way, I just got quieter after getting sick of being pretty sure I was right and yet watching all the focus (and money) flow away from the areas I work on.

Quite frankly, some with interests at the CTP and FDA seem to believe that when Congress approved the Family Smoking Prevention and Tobacco Control Act, the “TCA“ for short, it ratified the World Health Organisation’s Framework Convention for Tobacco Control (FCTC) treaty. …. This is very important because the WHO does not want to reduce the health risks associated with tobacco use. The WHO wants to eliminate all tobacco use, even use of tobacco products whose health risks are indistinguishable from those of medicinal nicotine.

I am shocked to hear that.  Oh, except for the fact that my colleagues and I were among those who made exactly that point about WHO many years ago, and we have been following the FCTC follies with all of that treaty’s implications for truly terrible public policy.

What I want to focus on now is the TPSAC and the forces who want to take the word, “science” out of the Tobacco Products Scientific Advisory Committee. …. The three industry representatives on TPSAC have been a troublesome team for the FDA. We have been very professional in asking all the questions the FDA did not want asked.  ….unlike the other scientific advisory committees that help the agency deal with difficult scientific issues, the real expertise on the TPSAC lies with the non-voting industry representatives, not with the voting members of the committee.  Indeed, the difference in expertise between the industry members and the voting members is so great; the FDA has to hide our expertise. Our expertise is listed as “Industry Representative.”  If the FDA listed our expertise, it would make the voting members of the committee look weak.

I should make clear that I am not writing this to criticize Dr. Lauterbach’s presentation.  It is just a good example, and he certainly deserves credit for bits like that.  My frustration is that he has to tell anyone most of this information at this late date.  However, I do have specific disagreements.  In particular, I take issue with the implications of this question:

So why doesn’t the TPSAC have academics who are experts in tobacco science, tobacco chemistry, and tobacco toxicology?

Setting aside the answer, the question implies that those are the most relevant fields.  But the matters being addressed by the Committee and the FDA are almost entirely about epidemiology, welfare economics (consumer preferences and such), and other social sciences.  No doubt chemistry will have its role, but it is pretty minor so far.  Indeed, where there has been focus on chemistry, that ignores much more important health and social science points.

….if we had such faculty members available to serve on TPSAC, the FDA would not want them on TPSAC, as they would ask the wrong questions. Tobacco and tobacco smoke are difficult materials, and those doing serious research soon learn to assume nothing and insist on proof before deciding the validity of a scientific proposition.

Right prediction about their opposition to experts, of course.  They did not want, and carefully avoided including committee members who might ask tough questions about the relevant sciences.  But the rest of that, ouch!  It seems to play right into their hands, sounding remarkably like 1960s-70s style industry obstructionism.  I am not saying that was what was intended, but the tough questions that are being ignored are along the lines of “how can low-risk smokeless products possible cause any measurable harm based on existing epidemiology and economics?”  Questions like “how can we know what to do until we do more research about smoke?” are not only the wrong question but sound a bit contrived.  I suspect the Serious people will come around on that too, eventually.

Those who write anti-tobacco materials generally stay away from the mainstream journals that cover the sciences associated with product regulation even though scientists from other parts of the FDA publish in such journals. Why? They know that the reviewers and editors of such journals have little tolerance for pseudoscience. So, those opposed to tobacco publish in journals such as Tobacco Control, Nicotine & Tobacco Research and other journals that welcome less than accurate science as long as it is anti-tobacco.

A nice point.  Of course, it is one that those of us who have been doing academic and academic-style research in the social sciences have been pointed out all along.

However, when such pseudoscience has made it to print, the industry, for the most part, has not challenged the bad science. ….  Fortunately, some of us who are not part of big tobacco, did the science, and got it published. I can assure you that you do not win friends when you write to a journal editor and show him that he let research into his journal that stated, if one took the experimental as it was written, the cigarettes were smoked well into the filter sections and that cigarettes were smoked under such variable conditions as to render the results useless.

How many times have I (and Rodu, and Enstrom, etc.) fought with publishers?  A lot more than we have written about, and we have written about quite a few cases.  I would contend that the social science side is far worse than the chemistry side, both in terms of publishing junk and censoring real science.

Action is required
.  Big Tobacco needs to step in and do its share to correct the errors in the literature and respond promptly to new ones.  ….  Unless someone acts, [an article he cites] is going to be used against dissolvable tobacco when TPSAC considers those products later this year.

Sounds right.  Also sounds a big familiar.

While we can hope that the FDA will learn from its mistakes and start using good science for tobacco product regulation, we have no guarantees that will happen.

Um, you might want to consider whether they believe they have made mistakes.  I think agreeing to the premise that there were mistakes is a prerequisite for learning from them.

We know that our legislators do not look favourably on regulatory agencies that do not use good science as the basis for their regulations. We are fast approaching the point when we will need to solicit their help in getting the FDA’s tobacco regulatory function back on the path that Congress intended. If we do not do it now, we may not have another opportunity.

So Congress is the best hope for defending good science?  Oh that is good news.  And it is because the regulators have acted the way some of us predicted that they would, and because no one is doing the science to push back against them because everyone decided to just trust the process.  On top of everything else, Congress’s role is predicated on their intent being enough different from what is happening that they are willing to micromanage it, as opposed to, say, exactly what those who were pulling the strings wanted and expected.

Some of us were un-“Serious” enough to have seen and discussed the impending problems from the start.  All it took was a bit of science (economics, polisci, historiography, epidemiology — chemistry was not so helpful). 

As Krugman went on to comment today,

you might think that hippies like me were basing their views on some wild and crazy, unorthodox version of economics, while the wise, judicious people who thought that [what was actually done] was just right were using standard analysis.  But actually it was the other way around. …. The hippies read the textbooks; the Very Serious People apparently rely on close analysis of entrails, or something.

It is an interesting question whether Krugman’s observations about how the Serious People come around to our hippie reality (and then get more credit because took the Serious position in the first place) will soon come true, as Lauterbach is campaigning for.  Or will it be that by the time they do, the whole matter will be buried far too deeply in the contents of those entrails.

Unhealthful News 181 – Avastin likely to be de-listed for treating breast cancer; if only they explained why

This week there was some seriously unhelpful health news.  One of the most talked about bits of health news of the last few days (example, example) is that an FDA committee concluded that the drug Avastin used to treat several types of cancer, is a bad choice for treating breast cancer.  It is likely that the FDA will therefore withdrawal approval for that use.

I was curious about what was known, what the concerns were, what motivated the decision, what will happen, etc., so read some of the news and health pundit reports on the topic.  I could have kept going, and probably pursued a more technical angle, but I started to find it more interesting to realize that I was learning almost nothing from what I was reading that was not contained in the headline. 

The committee’s unanimous judgment was that the risk outweighed the benefits.  The only counter-arguments discussed were breast cancer patients who believe they have benefited from the drug begging not to lose it.  Today it was announced that Medicare would still cover its use for breast cancer (because it will still be approved for other cancers, it will be on the market and FDA regulations do not prevent it from being used “off label”).  This brings up some questions.

“Risks outweigh the benefits” can have rather different meanings.  One of them is the subtle “if you use this drug rather than another then, adding up all the outcomes including cures and side effects, you are a bit worse off.”  That is a case where nothing much can be done except look at the overall statistics and go with them.  But there are other variations, an extreme version of which might be, “this drug saves 5% more of those who take it for a year compared to the alternative, but it rapidly kills 6% of those who take it.”  There is no practical difference among these unless it is possible to figure out if someone is in the group that benefits or suffers from the choice, and presumably that has already been done based on demographics and details of the cancer to the extent currently possible. 

There is one other possibility, where it is possible to start a treatment and figure out whether it is going well.  I have no idea whether that might be possible in this case.  You would think that after reading thousands of words analyzing the regulatory decision some information might have creeped in, but no.  Some of the severe side effects mentioned (digestive system perforations, bleeding) are such that they can be detected and perhaps treatment can be changed, but perhaps it is then too late or changing the treatment is not safe.  I am sure these are known, but no on reported them. 

Some pundits complained that the news stories took many paragraphs to get to the most important point, that the studies show that the drug does not improve survival.  I agree that this is the most important point.  But I take issue with the implication that this is all that is useful to know.  There is talk about continued research to find if there is a subset of breast cancer victims who might benefit; that is what pharma companies always want to do in cases like this.  But it might be possible to identify cases that are benefiting.  Or it might not.  The news and pundits appear to be utterly silent on that point.

This is interesting because of the amount of attention devoted to women who were asking that the drug not be taken away from them because they believed it was helping.  Not a single report or analysis I saw argued made the obvious point, that they have no way to know that because they have no idea what would be happening if they were not taking the drug.  (There is evidence that the drug slows cancer growth even while not improving longevity, which would create the appearance of benefit.)  On the other hand, no one suggested it might be the case that this subset is right about them being the ones who benefit (which would mean that others have been hurt because we know the balance is “no benefit”).  Perhaps it is the case that if someone escapes the nasty obvious side effects then having the drug is better than not having it.  That is kind of like the 5%/6% scenario I made up, wherein if it does not kill you early it is helping you.  Presumably this information exists, but the allusions in the news to there being some slight prognosis improvements for some stages of cancer were not very useful.

This brings up a second question, which is why anyone expert would suggest continued use is a good idea.  Individual consumers are often irrational, and mistakenly think that averages do not apply to them, and think they can see causation (that the drug is causing them to be healthier) when it is really too complicated to see.  Individual medics are no better.  But Medicare’s policy decision implies that someone who is supposed to understand these things thinks it is wise to keep using Avastin to treat breast cancer.  Yet to the news reader, there seems to be no basis for expert disagreement in the discussion.  If there is no benefit, then there is no benefit.  Again, presumably I could dig deeper into expert discussions and make sense of this, but how can it be that the news reports implicitly tell us there is this controversy, but no one thinks to report the basis of disagreement?

The only consternation reported was not about the challenge of scientific disagreement, but what to do with all of those poor women who are benefiting from the drug and testified in favor of keeping the indication.  (Answer: Um, let them keep taking it if they really want it so much?  It is not being banned after all.)  The committee hearing was even called a “death trial” for them (as in “death panel”), because they were not just statistics.  Some local news stories picked up individual examples of the human interest drama of those who will be deprived of this wonderful drug.  Oh, where to start.

We expect superficial news reporting that emphasizes uninformative stories over useful statistics.  In is pretty typical that the useful statistics are buried in the article.  But in this case, nothing that was reported allows the reader to have any idea if the anecdotal claims have any basis, or should have any effect on decision making.  There is the usual spate of statements like “the plural of anecdote is not data” from self-styled pundits, but that statement is not actually true.  There are plenty of situations where anecdotes about the non-average cases are informative.  There are cases where off-label use of makes sense for an identifiable subset, and so Medicare should pay for it.  Is this one of those cases.  Maybe someone understands these points and knows the answers, but they are apparently not among those writing the news and commentary.