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Janet Woodcock, head of the FDA Center for Drug Evaluation and Research is under investigation for ethics violations on the basis of a complaint filed by a drug generics manufacturer Amphastar that she had inappropriate ties to rival manufacturer Momenta Pharmaceuticals for a generic version of the blood-thinner Levenox for which they both sought FDA approval.

It’s interesting to think that a possible remedy to the FDA’s close ties with pharmaceutical companies and device manufacturers might come from some of the companies themselves, complaining about the unfair advantage that other companies enjoy due to their professional relationships with individuals at the FDA.


I saw an interesting medical news story this morning that said a small study was done that seemed to show that autistic children benefited from hyperbaric oxygen therapy (HBOT) compared to children who were exposed to slightly pressurised room air (hyperbaric oxygen chambers have higher levels of oxygen and are more pressurised).

I haven’t yet had a chance to read the study, so I am not sure how well done it is, but go and have a look to see for yourself.  The study is being published in the peer reviewed journal BMC Pediatrics, here is a link to the abstract and preliminary article.

The thing I found interesting about the particular report of this study in Medpage Today, is that there is some commentary by Paul Offit expressing scepticism about this study because the parties who conducted the studies (Daniel Rossignol, Lanier Rossignol, Scott Smith, Cindy Schneider, Sally Logerquist, Anju Usman, Jim Neubrander, Eric Madren, Gregg Hintz, Barry Grushkin and Elizabeth Mumper) are in some cases DAN! doctors who make their living treating autistic children, and who use HBOT to treat them, at least in some instances.

“I’d like to see [the study] reproduced in an academic medical center that doesn’t have the financial incentives,” said Dr. Offit.

That sounds a bit funny coming from Paul Offit, who spends his time studying, developing, handsomely profiting from and publicly promoting vaccines.  If the physicians in question have prima facie questionable intention and/or honesty because of their capacity to profit from their work, then one can’t help but wonder how Offit can avoid the very same criticism that he levies at them.

I happen to think it’s impossible to be utterly unbiased; every researcher comes to a study with an idea or a viewpoint that they expect to validate.  The methodologies of science aim to minimise these various biases, and of course where conflicts of interests exist, they should be completely disclosed.  But I think it’s quite something to disapprove of a study because the physicians profit from procedures they study and recommend, when one has profited from the development of a vaccine one has studied and recommends.  Offit routinely rebuffs criticism that he has a conflict of interest.  I wonder how he thinks these physicians who studied HBOT are differently situated.

In fact, in 2000 the Committee on Government Reform in the U.S. House of Representatives criticised practices of the Advisory Committee on Immunization Practices (which makes recommendations on childhood vaccines) with regards to their poor management of conflicts of interest, specifically citing Paul Offit (as well as others) who voted for the recommendation of the Wyeth RotaShield (rotavirus) vaccine on three occasions, when he was also developing a rotavirus (RotaTeq) vaccine with Merck, because of their worry about this as a conflict of interest.  They said “A recommendation for Wyeth-Lederle’s vaccine would help pave the way for future recommendations for the products of Merck and SmithKline-Beecham.”

That sounds like at least as worrisome a conflict as he is now concerned about with these DAN! doctors.

I’ve been noticing that there’s a recent new(ish) complaint against people that are concerned about safety of vaccines.  I’ve seen it in some blog posts, and seen it almost constantly in the online comment sections following various news articles and blog articles about vaccines.

The complaint is that people who question vaccines have been changing the nature of their argument over time.  According to this complaint it started with people being concerned about mercury and thimerosal in vaccines.  Over time, as thimerosal was removed (or reduced, as some critics would say) from vaccines, and as a corresponding decrease in autism was not apparent, the “anti-vaccine” people changed their argument. Now they claim that aluminum, formaldehyde and polysorbate 80, etc. are the basis for concern about vaccines.

Apparently some people find this to be some fatal flaw, and from this it apparently follows that any criticism of vaccines is trumped automatically.  But I don’t see that this point has (or should have) any weight.

First of all, points in scientific discussion and debates change over time.  Not only do they change, they ought to change in response to advances in knowledge and to changes in thinking.  Anyone who stays wedded to the first idea they had is either truly perfect, or is a little too invested in being correct.

Consider the medical quest to treat ulcers.  Physicians and researchers considered excess stomach acid production to be the cause of ulcers for decades.  They even tried crazy things like freezing the lining of the stomach to try and reduce acid production until gastric linings started sloughed off and causing lots of bleeding.  I’m glad no one got in their way and said that they couldn’t change their theory halfway through, or was upset because they modified their position in light of further experience.

Furthermore, at least with regards to asthma, allergies and autism, it is reasonable to have a heightened and continuing sense of concern about vaccines, since they are direct attempts to alter the immune system.  Lots of children with autism seem to have immunological problems, and asthma and allergies are both dysfunctions of the immune system.  I’m not remotely suggesting there is evidence of anything causal because of this, but I do think it means it is well worth thinking about and looking at vaccines carefully, since we’re manipulating the immune system in ways that are not well understood, and we’ve got a lot of children appearing with immune problems.

Secondly, the increases in neurological problems, asthma/allergies, ADD and ADHD, bipolar disorder and autistic spectrum disorders in children ARE happening concomitantly with the increases in the number of vaccines that children get.  This is obviously another concern NOT causative on its face, but why does that then make it somehow crazy to want to examine vaccines more closely, as well as their constituent parts?

And finally, if the concerns about vaccines, and their components are so ridiculous and ill-founded, then why aren’t the easy rebuttals just trotted out instead of crying not fair, they changed the game?  For myself, I’d prefer that to all these pointless charges of fallacious argument, and I’m sure there are lots of others who are listening for that as well.

“…my brother’s story also taught me about the loneliness of the visionary, the selfishness of our culture, and the arrogance that blinds many scientists.” – Christina Odone

Lorenzo Odone was a boy diagnosed at age 6 with the rare genetic disorder adrenoleukodystrophy (ALD), where an accumulation of fatty acids occurs in the body due to a missing transporter protein. This results in damage to the myelin sheaths that insulate the axons of nerve cells in the body, and signals can no longer be sent via these axons, resulting in increasing disability, such as losses of sight, hearing and movement.

Soon after his diagnosis, Lorenzo’s parents, Augusto and Michaela, were told by physicians that their son would soon be dead, and that there was nothing to be done.

But the Odones instead set about researching Lorenzo’s disease, and came upon a combination of acids (Lorenzo’s Oil) could stop the production of the fatty acids that were causing the problem. Once given to Lorenzo, the oils worked, and although they could not re-myelinate his already damaged cells, they greatly slowed the progression of the disease.

The Odones created an organization aimed at accelerating and supporting research into the repair of myelin and treatment of leukodystrophies and demyelinating disorders: The Myelin Project.

Lorenzo died just a couple of days ago, the 30th of May 2008, the day after his 30th birthday: 22 years later than the physicians predicted. And it was only in 2005 that research on the Odones’ patented Lorenzo’s Oil showed that young boys who had yet to display symptoms of ALD, who has the oils added to their diet, had a statistically lower chance of developing signs of the disease. And more research is being done.

It’s a lucky thing for Lorenzo that his parents persevered, and weren’t satisfied with the best answers that medical science had to offer. Today skeptical parents engage in similar acts of love and dedication to their children when they demand unbiased studies addressing the safety of the vaccine schedule, or they biomedically treat the medical problems borne by their autistic children, when physicians everywhere assure the public that yes, everything is safe, or no, nothing can be done, and anyone who says otherwise is a quack or a parent-in-denial. In spite of the “arrogance of scientists” that Lorenzo’s sister Christina Odone refers to in The Daily Mail, parents all over the world act against the advice of the medical establishment that said nothing could be done for Lorenzo.

I come across stories about what the press likes to call “vaccine-preventable diseases” rather frequently. There are often warnings about the clusters of illness caused by people who choose not to vaccinate. They point to mini-epidemics of whooping cough, measles and mumps, and lament how all this wreaks havoc even for those who have been vaccinated (since vaccines are not 100% effective). There’s always an outbreak here or there, and if you search the archives of any major newspaper you will get quite a few hits.

But I can’t remember the last time I saw the press covering a severe vaccine reaction, or death. I suspect it has something to do with my observation that when there is a temporal relationship between a vaccine and an illness or death, we are reminded that temporal relationships are not the same thing as causality, and that it is a coincidence that a problem occurred shortly after vaccination. But in the amazingly rare instances that a child dies of a vaccine-preventable illness, like measles, the temporal relationship takes priority, and we are told that the child died of measles, even if the child was taking azathioprine or other immune-suppressive drugs to shut down their immune system due to other ailments or organ transplant.

Whatever the reason, today I can stop complaining about the lack of coverage for vaccine reactions, because I came across a story this morning about a healthy three month old infant who received an MMR vaccine, developed a fever, and seemed generally unsettled, who then died the following day. Of natural causes.

Consultant forensic pathologist, Dr Charles Wilson, told the hearing that he believed the baby had died of pneumonia.

He said: “Kenzie had the early stages of a lung infection, the kind you tend to see with bacteria. It was the earliest stage of pneumonia. It was an entirely natural, tragic and unforeseeable cause of death.”

I’m glad the pathologist mentioned that the pneumonia was the type you tend to see with bacteria. That would (phew!) completely rule out any involvement of the vaccine then, since it is comprised of three live-attenuated viruses. I’m a little surprised though, that he thought the pneumonia was the type that one tends to see with bacteria. Didn’t he check the infected lung tissue? I’m surprised he doesn’t know what pathogen was in the lungs.

I’m going to confess now that I find this a bit odd. Do children who seem fine and healthy often die in the very beginning stages of pneumonia, before anyone knows they are ill? Maybe this is truly so common that there is no need to raise an eyebrow, or to send some lung tissue to histopath.

In order to take this article, and the pathologist, at face value we have to believe: 1) the child was absolutely fine at the healthcare visit where he had received the MMR, and that there was no sign of pneumonia that a clinician should have noticed, even if the child was going to die of it about 30 hours later, 2) the administration of the MMR was strictly coincident in time with the unrelated fatal illness, 3) healthy children die rapidly in the early stages of infections, even when it is sufficiently early that there are no symptoms of any concern, and 4) that #3 happens often enough that no one bothers to send infected tissue for histopathological assessment. Apparently the coroner agrees this is reasonable:

Coroner Jennifer Leeming recorded a verdict of death by natural causes.

For myself, I remain slightly skeptical.

After I began writing down some of my thinking about the whole anti-vaccine issue contained in some of my earlier posts here, I had a tiny bit of a panic attack. What if everything I wrote wasn’t absolutely, positively up-to-date, or if I had misunderstood something I’d read in a study or if there was a study I didn’t know about or some extra-scientific, political debate circling out there that had some bearing on what I had to say such that it wasn’t all unassailably accurate by anyone’s interpretation?

In the face of these thoughts I did what I do when I am not sure that I’m right (pretty much all the time, actually) which is to do even more reading, and so I skipped around a bit at some of the sites of the more erudite critics of people who are against vaccines.

The reading I did caused me to question things some more – I had to go back and look over a few relevant parts of studies, and I kept stopping to think things through in my mind. Then suddenly I read something that let me completely relax and stop worrying about the comments made by those people at the end of the New York Times article, who were so outspoken about the apparent simplicity of the vaccine controversy.

It was the way in which one critic, after ridiculing anti-vaccine people for thinking that the CDC might be biased or were trying to promote a particular agenda, dismissed a study that could be interpreted as strongly anti-thimerosal for exactly the same sort of reason (being funded by a group with apparent interests). It reminded me that these people will go as far as they need to (arguing with a researcher’s choice of spectrographic tests to determine whether there is mercury contained in a tissue sample, if they don’t like the study’s conclusion, whereas an epidemiological study where the data was lost and so cannot be verified is fine if it shows their desired result). And the anti-vaccine crowd is often the same.

But the most striking moment came for me later, as I considered my personal trail of thoughts about this whole vaccine business. I wondered about my wavering fear concerning the strength of my beliefs and thinking somehow it meant that maybe my position was uncertain. Does it somehow make my stance less tenable if I feel that it can be shaken?

And I’ve thought about this a lot since this first occurred to me, and my answer is an unqualified: no.

I think that being committed to a position for its own sake plays a part in the problems in these sorts of long-enduring debates, where intelligent people disagree. People become extremely personally invested in being correct, especially once their decision has been implemented with regards to the well-being of their children, or when they become publicly committed to it (even if only by authoring a bit of writing on the web). Then nothing you show them can change their mind or shake their commitment to their position. They are forever reading studies and articles, looking for the smallest shred of evidence that supports their position, and happily discarding anything that doesn’t.

So the wavering, for me, was just a sign that maybe I am still the kind of thinker that I hope to be: always open to some new bit of evidence, some new well-constructed study that would cause me to begin to question the beliefs that I currently hold, and someday perhaps, some evidence that completely topples them. I’d like to see this all over the vaccine debate, instead of all the made-up minds, the complicated machinations to defend one’s position, and the double standards for evidence that supports or denies one’s position. I hope I can live up to this myself; I think it’s a worthy aim.


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