Respectful Insolence

There’s been a bit of bad news on the vaccination front:

ATLANTA - More than a million doses of a common vaccine given to babies as young as 2 months were being recalled Wednesday because of contamination risks, but the top U.S. health official said it was not a health threat.

The recall is for 1.2 million doses of the vaccine for Hib, which protects against meningitis, pneumonia and other serious infections, and a combination vaccine for Hib and hepatitis B. The vaccine is recommended for all children under 5 and is usually given in a three-shot series, starting at 2 months old.

Drug maker Merck & Co., which announced the recall after testing this week showed a sterility problem in a Pennsylvania factory, said concerned parents should contact their child’s doctor.

“The potential for contamination of any individual vaccine is low,” said Merck spokeswoman Kelley Dougherty.

The health risk:

Parents will probably be concerned, CDC officials acknowledged. Should the vaccine later prove contaminated, health officials believe most children will experience, at worst, a skin irritation around the vaccination site. Problems could be worse for children with compromised immune systems.

Such problems would have appeared within one week of the vaccination, Schuchat said, adding that there have been no reports suggesting vaccine contamination so far.

The contamination involved unspecified equipment used in making the vaccine, which involves taking concentrated Hib virus, diluting it and combining it with other agents. Kuter said that during a routine evaluation of Merck’s West Point, Pa., vaccine plant, a sterility test determined that the equipment was contaminated with a bacteria called Bacillus cereus, or B. cereus.

In other words, very, very low. However, expect antivaccinationists to milk this incident for all it’s worth:

The recall is likely to heighten a debate over childhood vaccines and their safety and whether too many are required. Some parents are distrustful and suspect some vaccines of being linked to autism, although scientific studies have not shown such a connection.

At least the writer acknowledges what science has shown: that there is no credible scientific evidence linking vaccines to autism. What also should have been mentioned is that the reason thimerosal, the mercury-containing vaccine preservative blamed for autism, used to be used in the manufacturing process of such vaccines is to prevent contamination of this very sort creeping in. I don’t know if it was used here, which would have been useful information. (The reasons that some multidose containers of vaccines still contain trace amounts of thimerosal far below what was contained in vaccines before 2002 is because it is still used during steps in the vaccine manufacturing process.) If it wasn’t, then it would be an indication to me that its removal, which although unnecessary from a scientific viewpoint but irresistible from a political standpoint, was not without a price.

From my perspective, this incident actually demonstrates that the vaccine monitoring system works. After all, no contamination has been detected, and there have been no reports suggestive of problems due to contaminated vaccines; yet as a preemptive measure a huge supply of vaccines is going to be recalled. It also demonstrates how precarious our vaccine supply is, given that a recall by a major supplier of a very important vaccine that has saved many lives can disrupt the Hib vaccine supply for the nation for nine months. The number of vaccine suppliers has dwindled since the 1950s because, contrary to the claims of antivaccinationists, most childhood vaccines aren’t that profitable to develop and manufacture, and the liability concerns are huge given the millions of children who are vaccinated. What worries me about this incident is that it brings to light just how little it would take to jeopardize our supply of critical vaccines.

Comments

  1. #1 MartinM
    December 13, 2007

    Occasionally, food is recalled due to contamination or the possibility thereof. I don’t recall anyone using this as evidence that food is inherently a bad thing.

    Still, logic never was the anti-vax tool of choice.

  2. #2 jre
    December 13, 2007

    I heard this story on the radio this morning.
    One expert called for comment pointed out that the pool of Hib infection is very low right now, precisely because the vaccine has been in widespread use for a while. She said that we have some time, but not unlimited time, to reintroduce the vaccine.

    I recall Dr. Flea’s post on Hib, and the comical furor that erupted in comments. He was right, and the post was a good one. It is only within the last few minutes that I tried to look it up, and discovered to my dismay that Flea knows a lot more about medicine than he does about law. A belated goodbye, Dr. Flea. I predict that, when the dust settles, you’ll at least be vindicated on the subject of Hib.

  3. #3 PlanetaryGear
    December 13, 2007

    Shame that the vaccinations dont have some kind of preservative in them to keep any contamination from growing during shipping… but they just took that out…

  4. #4 Travismc
    December 13, 2007

    The problems is going to be with the media, our local CBS affiliate here Portland, Me ran a piece making it seem like the vaccines were already contaminated.

  5. #5 bsci
    December 13, 2007

    I first saw the AP article on the SF Chronicle which allows comments. The article left the front page rather quickly so only a few people commented. Follow the link to read the comments if you enjoy either a good laugh or for a significant increase in your blood pressure.

    http://www.sfgate.com/cgi-bin/article/comments/view?f=/n/a/2007/12/12/national/a132300S87.DTL

  6. #6 TheProbe
    December 13, 2007

    I visited the SF Chronicle site and left a few blood pressure raising comments. A pediatrician posted and chewed out the loons, too.

    The bottom line with this story is that the system worked. Too bad the CDC and FDA are spineless and allowed it to happen by removing thimerosal.

  7. #7 #1 Dinosaur
    December 13, 2007

    The contamination involved unspecified equipment used in making the vaccine, which involves taking concentrated Hib virus…

    Didn’t anyone pick up that Hib (Hemophilus Influenza type b) is a bacterium and not a virus?

  8. #8 Orac
    December 13, 2007

    Ack! I should have noticed that.

    But, hey, to some science journalists it’s, “Virus, bacteria, what’s the difference?”

  9. #9 CleveDan
    December 13, 2007

    how is the new world order supposed to maim these kids if they keep doing voluntary recalls. someone get Alex Jones and Jenny McCarthy on the phone!

  10. #10 DLC
    December 13, 2007

    I can already see the hysteria-storm on the horizon.
    Get your sou’westers and oilskins out.

  11. #11 Mike O'Risal
    December 13, 2007

    But… why would a whole industry replete with high-priced attorneys and dedicated to poisoning children in the first place bother with a recall? I mean, what’s a little skin rash when you’ve set out to make everybody’s kids autistic and spend all your time covering it up?

    You know, baby-eaters and all that.

  12. #12 wfjag
    December 13, 2007

    In “The Culture of Fear: Why Americans Are Afraid of the Wrong Things” (1999), at pp. 175 to 179, Prof. Glassner discusses the DPT vaccine scare of the 1980’s to mid 1990’s. Barbara Loe Fisher and her National Vaccine Information Center (NVIC), getting coverage from such scientifically minded reporters as Katie Couric, and the 1994 Miss America, Heather Whitstone (who is deaf, and whose mother attributed that to her receiving the DPT vaccination at 18 months old), helped generate a huge vaccine scare (as well as generated significant numbers of new member for NVIC). In showing the ineffectiveness of strong government action and findings of medical science, Prof. Glassner states at p. 177:

    “Instead, the vaccine scare underscores a fundamental if regrettable reality about metaphoric illnesses, and more generally, about the persistence of fear in American society. A scare can continue long after its rightful expiration date so long as it has two things going for it: it has to tap into current cultural anxieties, and it has to have media-savvy advocates behind it.”

    Events since then: Wakefield published his “study” in Lancet in 1999 claiming that the MMR vaccine caused autism, which study has been de-published by Lancet, almost all of his co-authors have withdrawn their names from the article, the “findings” were exposed as frauds by the UK courts, and the “experts” relied upon by plaintiffs in the trial in the US Vaccine Court last summer were shown to lack a sound scientific basis for their opinions.

    It only took 8 years and hundreds of thousands (maybe millions) of dollars in costs to refute the Wakefieldians.

    Now, you can look at an Hib vaccine scare. Ironic, isn’t it, that Prof. Glassner notes at p. 178 that Miss Whitestone’s deafness was, in fact, caused by infection by the haempphilus influenzae bacteria, “which can be prevented by means of a vaccine that became available in the late 1980s.”

  13. #13 Schwartz
    December 13, 2007

    In Canada today, doctors were told to stop using MMR-II.

    “All six people, who were treated and have fully recovered, received an inoculation from the same batch of a product known as MMR-II, which is sold by Merck Frosst Canada Ltd. They experienced anaphylaxis, a potentially fatal reaction.”

    http://www.theglobeandmail.com/servlet/story/RTGAM.20071213.wmumps13/BNStory/specialScienceandHealth/home

    I would also not be so confident in the monitoring process:

    “The Food and Drug Administration can withdraw a vaccine batch if there is any question about that particular lot’s safety or effectiveness. It has not recalled a vaccine lot because of safety concerns since 1955.” — Paul Offit.

    I would be very skeptical that there has not been a single “hot” lot in the United States since 1955 or even since Vaers has been running. I would be especially skeptical since the FDA had been asking Chiron for years to clean up it’s act regarding the flu vaccine manufacture until the UK finally shut them down a few years back.

  14. #14 Schwartz
    December 13, 2007

    wfjag

    That may be very true, but there are other examples from that time frame.

    “She discovered that the Trivax vaccine used on her son, from a batch numbered 3,741, had been released by the company despite it having failed to pass a critical safety test. Documents revealed that the 60,000 individual doses within this batch were known to be 14 times more potent than normal.

    At the time the Irish judge accused GlaxoSmithKline – then known as Glaxo Wellcome – of negligence and attacked the company’s poor quality control at its Kent laboratory. Immunology experts condemned Glaxo in court for what one US scientist described as an ‘extraordinary event’.”

    http://observer.guardian.co.uk/uk_news/story/0,6903,746568,00.html

  15. #15 Schwartz
    December 13, 2007

    Another good example from Canada (letter in CMAJ):

    “After retrieving the lot numbers of the vaccines given to my anaphylactic child I sent in an Access to Information request to Health Canada for 1) the 100% composition of the vaccines my child received and 2) a list of vaccine adverse events reported for the 8 lots he received. Health Canada can’t provide me with a 100% composition because it’s proprietary information. For the adverse event information I was asked to pay $600 down and $1200 in fees. This information, from 1993-95, was not on a computerized database – why wasn’t it?

    After waiting a year and paying only for photocopying, I received the data from Health Canada. I had to manually count the 975 reactions: death, seizure/convulsion, dysopnoae, speech disorder, allergic reaction, adenopathy, hypotonic-hyporesponsive episode, severe pain and/or swelling, screaming episode, hypokinesia, persistent crying, severe vomiting and/or diarrhea, lethargy, fever, cyanosis, rashes, eczema, pneumonia, lymphocytosis, sterile abcess/nodule/necrosis, infective abscess, tachycardia, gait abnormal, ataxia, bulging fontanelle, sepsis, vaso-vagal reaction, tremor, arthritis, cellulitis, bradyapnoea, delirium, reduced consciousness, shaking, somnolence, anaphylaxis, apnoae, encephalopathy, asthma, injection site reaction, shortness of breath, and confusion.

    Repeated attempts to get an explanation as to why one particular lot was able to rack up 664 reactions (including 34 seizures/convulsions) without being pulled from the market have gone unanswered by local and Ontario health officials, officials with Health Canada and participants of IMPACT. Also unanswered: The National Report on Immunization, 1996 states: “If the number and type of reports for a particular vaccine lot suggested that it was associated with more serious adverse events or deaths than are expected by chance, the federal government has the responsibility and will, as well as the legal authority, to immediately recall that lot.” The U.S. Centers for Disease Control considers a vaccine “hot lot” one that generates reports of more than two deaths or two convulsions or a total of 10 adverse reports. Health Canada officials reported an investigation should be initiated after a “cluster of reports” and that means “3 or more.” This being the case the majority of vaccines my child received should have been recalled? Why weren’t they?”

    http://www.cmaj.ca/cgi/eletters/170/4/437

  16. #16 Schwartz
    December 13, 2007

    I think I would actually feel more comforable if there were more forced recalls. That would at least be a better indication that the detection system was working. A system that never finds any problems (as quoted by Paul Offit above) is always suspect.

    A great example is the BSE fiasco in North America. They claimed for years that NA was BSE free but even naturally occurring rates would have dictated that some cases should have spontaneously shown up naturally. Once they started to do “better” testing, more cases were found.

  17. #17 Freddy the Pig
    December 14, 2007

    I was wondering when the small number of anaphalactic reactions to a Mumps vaccine in Alberta would get dragged into this, What Scwartz did not mention was “She, as well as public health officials, also pointed out that at least five of the six patients who fell ill in Alberta had a history of allergic reactions.” In other words there is no real smoking gun here, but the lot has been withdrawn as a precaution.

    As to the apparent horror story about effects retrieved under the FOIA – since there is no indication of how many doses resulted in the number of adverse events, there is no indication how many of these adverse events were due to the vaccine or were coincidental. For example, one of the adverse events was “persistent crying”. There is plenty of post hoc in all of these adverse events.

  18. #18 isles
    December 14, 2007

    The thimerosal removal aspect didn’t occur to me when I first heard about this. Excellent point, Orac.

  19. #19 wfjag
    December 14, 2007

    Schwartz:

    Interesting point, but different than the one I made. The DPT vaccine scare described by Glassner in the 1980s to early 1990s was over uncontaminated vaccines. The DPT vaccine caused no anticipated side-effects, when side-effects were experienced, they were minor, and the DPT vaccine likely prevented many children suffering the serious effects or death had they not been vaccinated against the diseases the DPT vaccine prevented. Miss Whitstone’s deafness was due to Hib infection, and not caused by either the DPT vaccine or vaccination with a vaccine that was contaminated in any way. Thus, it’s directly comparable to the MMR vaccine scare and the disabilities or deaths of children who contracted wholly preventable diseases because their parents were scared by Wakefield, and others spreading his Road-Apples, and so did not have their children vaccinated.

    The case you refer to resulted from Glaxo’s knowing release of a contaminated product, the contamination in which caused the injury.

    While that is somewhat comparable to the current matter which is the subject of Orac’s blog, the difference is that the manufacturer recalled the Hib vaccine suspected to be contaminated, before any government action. Further, according to the press reports so far (which may or may not be accurate, I’ll concede) there’s no confirmation that the Hib vaccines were, in fact, contaminated. Rather, laboratory standards were not met, raising the possibility of contamination, and that was sufficient to prompt the recall.

    Contrast this with Wakefield. The evidence presented in the Vaccine Court last summer is that one of the reasons for Wakefield’s bogus results was that his lab was contaminated with Measles virus from his own lab (DNA testing showing the virus to be the strain supposedly being used as a control, and neither a wild strain of Measles virus nor the strain used in the MMR vaccine), but that Wakefield’s lab techniques and standards were so deficient, he did not realize that his lab was contaminated, and that was the source of his findings. Autism Diva has extensive coverage of the evidence in the trial.

  20. #20 Schwartz
    December 14, 2007

    Freddy,

    I did not intend to mislead anyone as I did include a reference to the full article. I still believe that 6 severe reactions (in adults I believe) is far higher than normal otherwise Health Canada would not have suspended use of the vaccine (almost unprecidented).

    If it’s not unusual, then allergies would have to become a serious contraindication for the vaccine, and that would either indicate improper labelling or improper application by the doctors. Either way, there is a problem.

  21. #21 Schwartz
    December 14, 2007

    Isles and Orac,

    You crack me up about the inferred possible Thimerosal link.

    The main usage for Thimerosal in childhood vaccines was for preventing contamination during USE not manufacture.

    From the FDA website:

    “Preservatives are compounds that kill or prevent the growth of microorganisms, such as bacteria or fungi. They are used in vaccines to prevent bacterial or fungal growth in the event that the vaccine is accidentally contaminated, as might occur with repeated puncture of multi-dose vials. Vaccines, both in the United States and throughout other parts of the world, are commonly packaged in multi-dose vials. In some cases, preservatives are added during manufacture to prevent microbial growth; with changes in manufacturing technology, however, the need to add preservatives during the manufacturing process has decreased markedly.

    Preservatives have been used in vaccines for over 70 years. The requirement for a preservative in multi-dose, multi-entry vials was placed into the Code of Federal Regulations (21 CFR 610.15) in January 1968. There are exceptions to this requirement for preservative, primarily involving the live-attenuated viral vaccines.

    The general need for preservatives in multi-dose vials has been underscored by cases in which multi-dose vials that did not contain preservatives become contaminated during use and caused fatal infections in vaccine recipients; cf. the Narrative Section on Thimerosal.”

    http://www.fda.gov/cber/vaccine/thimfaq.htm

    Time to get off that bandwagon…

  22. #22 Uncle Dave
    December 14, 2007

    Flu shots now mandatory for New Jersey preschoolers

    TRENTON, New Jersey (AP) — New Jersey on Friday became the first state to require flu shots for preschoolers, saying their developing immune systems and likelihood of spreading germs make them as vulnerable to complications as the elderly.

  23. #23 notmercury
    December 14, 2007

    Schwartz,
    Not only was thimerosal routinely used to prevent contamination DURING the manufacturing process, it’s use was greatly curtailed in response to mercury hysteria.

  24. #24 Schwartz
    December 14, 2007

    wfjag,

    You’re right that my examples have more applicability to Orac’s article (i.e. faith in inspections).

    I would be careful about stressing the “voluntary” nature of the recall though. I guarantee you that the regulators were well informed and aware of the situation, and I’ll wager that the contamination was severe enough that a “voluntary” recall was easily negotiated. Similar situations occur all the time with product recalls which are “voluntary”. i.e. The company voluntarily withdraws them before the regulatory body forces them too — witness the recent “voluntary” withdrawal of cough medicine one day before the regulators met to decide on the issue despite complaints of lack of efficacy for over a decade on the issue.

    Regarding the Omnibus hearings, I hope that you’re not using Autism Diva’s account as your only source — she is admittedly biased on the matter. One interesting point about Dr Bustins testimony is that he was not called as a witness in the GMC hearings. I find his exclusion very surprising since the GMC hearing is actually about Wakefield and accusations of scientific fraud, yet this key witness was not brought forward by the prosecution from what I’ve read to date. I have no explanation.

    I totally agree that the press combined with scaring people almost always leads to an overreaction. Unfortunately, the only alternative is hiding information from people, and that leads to a very slippery slope which can’t be justified ethically. I am absolutely convinced that vaccine problems are silently dealt with to preserve the assumption of safety of the program because the doctors in charge feel it is justified to protect the program. The example I noted above from Canada is a good example of this or it’s due to pure incompetence. I suspect the former.

  25. #25 Schwartz
    December 14, 2007

    Notmercury,

    If you read the quote from the FDA, they stated it was indeed used in manufacturing, but that requirement has drastically decreased due to changes in technology.

    Thimerosal was hardly the only preservative historically used in vaccines — Canada and other European countries removed Thimerosal from vaccines many years before the United States without incident. To even suggest that this contamination was linked to a lack of Thimerosal usage is ludicrous and disingenious.

    You’ll note that multi-vial vaccines are still very much in use without it, and still using some form of alternative preservatives which have been in use for a long time.

    You’re barking up the wrong tree.

  26. #26 Catherina
    December 14, 2007

    Thimerosal should never be a substitute for good manufacturing practise.

  27. #27 notmercury
    December 14, 2007

    No tree, no barking.

    Thimerosal is used, still used, to clean and sterilize manufacturing equipment, in other words to avoid microbial contamination.

    It can be more effective than alternatives so why is it so ludicrous to think that limiting thimerosal may lead to process contamination?

  28. #28 Half MD
    December 14, 2007

    I’m consistently amazed by the stupidity of the American public. Vaccines are probably one of the most impactful healthcare innovations in the history of mankind. They have severely decreased morbidity and mortality of communicable diseases. That the anti-vaccination crowd continues to amazes me. Even more jaw-dropping is that they have such a strong audience. If I were a pediatrician, I would refuse to treat patients whose parents refused vaccinations.

  29. #29 Schwartz
    December 14, 2007

    Notmercury,

    “It can be more effective than alternatives so why is it so ludicrous to think that limiting thimerosal may lead to process contamination?”

    Because many others have successfully eliminated it years ago and replaced it with alternatives. Where is there a shred of evidence to suggest that this contamination was the result of Thimerosal elimination?

    If I recall, Chiron was having all sorts of contamination problems while using Thimerosal in their flu vaccines for years.

    If those arguments aren’t enough, a simple check on the FDA website shows that the combination Hib/Hep B vaccine NEVER contained Thimerosal (not even a trace), and the Hib vaccine had it’s Thimerosal removed in 1999.

    You’ll have to look elsewhere for damage due to Thimerosal elimination.

  30. #30 Schwartz
    December 14, 2007

    Half MD,

    I don’t disagree that some vaccines have greatly benefited our society, however your proposal to refuse to treat patients who refused vaccinations certainly explains why you shouldn’t be a paediatrician.

    What ethical justification could you possibly give for such reasoning? I suppose you would refuse to treat all overweight people? Or people who have high colesterol from poor diets? Or how about someone who smokes? An Alcoholic?

    You wouldn’t be treating too many people.

    I have a friend who’s doctor told them that they would remove them from their practise if they refused vaccination for their children, because the diseases were so rare, that she wouldn’t recognize it. That is a good example of incompetance. Vaccines aren’t 100% effective, and if my Paed. couldn’t recognize the illness, then I would want another Paed. anyways.

  31. #31 HCN
    December 14, 2007

    Half MD wrote “I’m consistently amazed by the stupidity of the American public.”

    Mr. Schwartz is Canadian:
    http://www.autismvox.com/a-not-so-religious-exemption/#comment-246141

  32. #32 Schwartz
    December 14, 2007

    HCN,

    LOL, you got me there. ;)

  33. #33 Orac
    December 14, 2007

    Regarding the Omnibus hearings, I hope that you’re not using Autism Diva’s
    account as your only source — she is admittedly biased on the matter. One
    interesting point about Dr Bustins testimony is that he was not called as a
    witness in the GMC hearings. I find his exclusion very surprising since
    the GMC hearing is actually about Wakefield and accusations of scientific
    fraud, yet this key witness was not brought forward by the prosecution from
    what I’ve read to date. I have no explanation

    Dr. Bustin’s testimony was utterly devastating to Wakefield and his methods.

  34. #34 Schwartz
    December 15, 2007

    Orac,

    I didn’t say otherwise. I agree based on reading the transcript.

    I also know that he was not on trial in the US and did not defend himself there. So why no testimony in the GMC where a proper defence could be mounted?

  35. #35 MartinM
    December 15, 2007

    What ethical justification could you possibly give for such reasoning? I suppose you would refuse to treat all overweight people? Or people who have high colesterol from poor diets? Or how about someone who smokes? An Alcoholic?

    Those conditions aren’t transmissible.

    One interesting point about Dr Bustins testimony is that he was not called as a witness in the GMC hearings.

    I was under the impression that the GMC is considering only the circumstances surrounding the original study which kicked off the MMR scare.

  36. #36 Schwartz
    December 15, 2007

    MartinM,

    I believe that is exactly what Dr. Bustin’s testimony applied to, the PCR results used in the original MMR study. I can only think of 4 reasons that he wouldn’t testify:

    1) Dr. Bustin refused to testify
    2) Dr. Bustin was unable to testify due to some sort of agreement (perhaps a settlement?)
    3) Dr. Bustin wasn’t considered a credible witness
    4) The GMC didn’t think the testimony was applicable

    I fully expected him to testify after reading the Omnibus transcripts, and am still quite surprised that he has not come up, nor has any part of his testimony come up at all in the GMC hearing from the accounts I’ve seen. I will qualify, that I have not seen a transcript of the GMC hearing and only have access to biased reports so far but I would have expected to see some sort of information since his testimony is so potentially damaging.

  37. #37 Schwartz
    December 15, 2007

    Freddy the Pig,

    More facts for you.

    Historically in Canada > 90% of Anaphylaxis reactions to vaccines reported were ruled “possible”, or “probably” related to vaccination based on followup analysis (the vast majority being “probably”.

    http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/06vol32/32s3/index.html

    According to the Canadian Immunization guide, anaphylaxis is a rare serious reaction and occurs < 2 times per million applications.

    http://www.phac-aspc.gc.ca/publicat/cig-gci/pdf/cig-gci-2006_e.pdf

    Only 62K vaccinations had occurred in Alberta as part of the new program that got kicked off there.

    From the same guide, there is no contraindication stated based on other allergies (including eggs) unless a previous reaction to the vaccine was reported.

    “The minute quantity of egg proteins contained in the MMR vaccine seems to be insufficient to cause an allergic reaction in egg-allergic people.”

    Given that context, your comment that this is “a small group” is very misleading since until further investigation is performed, it is very significant statistically. Given the facts, I think it is very prudent for them to suspend the use of that vaccine and investigate further. For you to allude otherwise is irresponsible.

    I highly doubt it is a problem with the vaccine itself, as it has been in use for quite a while and no clustered problems like this have been in the past. It is much more likely there is a problem with a specific lot or set of lots. For bumbling Canadian health officials to actually suspend anything indicates the problem must have been viewed as quite serious.

    Or maybe it’s a new trend in safety awareness here, since we also cut off half the worlds supply of medical isotopes because of brand new safety considerations (backup power for the reactor) despite having ignored the problem for decades.

  38. #38 Schwartz
    December 15, 2007

    Posting error above:

    It should read: “According to the Canadian Immunization guide, anaphylaxis is a rare serious reaction and occurs in less than 2 per million applications”

  39. #39 MartinM
    December 16, 2007

    I believe that is exactly what Dr. Bustin’s testimony applied to, the PCR results used in the original MMR study.

    There were no PCR results in the original study. The claim that measles virus had been found in the guts of autistic children came later.

  40. #40 daedalus2u
    December 16, 2007

    Bustin only had testimony that related to how sloppily and poorly the PCR tests were run. Being a sloppy and a poor researcher is not a crime, and is not what Wakefield is being charged with.

    In the Omnibus hearing, Bustin testified that the PCR results which were interpreted as a finding of measles virus in the gut were wrongly done and there was no legitimate way they could be interpreted as evidence for measles virus being found. That is important in determining whether in fact, measles virus from the vaccine did cause autism in that particular case.

    It is my understanding that Bustin never spoke with Wakefield, and so can’t testify about if and why Wakefield fraudulently published results indicating the presence of measles virus after he was told by one of the researchers who actually did the PCR testing that they were all false positives. I presume that researcher did testify.

    There are many reasons why a working scientist would not want to testify. It is a pain, it wastes a lot of time, it doesn’t advance science or a scientists’ career a single bit. No doubt Bustin has better things to do than waste his time slapping down Wakefield. The scientific community has already addressed Wakefield’s work. None of it is reliable. Until Wakefield successfully addresses the credible allegations of fraud that cloud all of his work it is and will continue to be considered unreliable and of zero value. No one has to “prove” Wakefield’s work is unreliable. The onus is on Wakefield to prove it is reliable.

    Being a sloppy or bad researcher is not a crime. Lying about research results to influence a court proceedings is a crime. Lying to patients to defraud them is a crime. Abusing a position of trust for self-gain through fraud and lies is a crime. These are serious crimes which Wakefield appears to be guilty of, and should be punished for. Being sloppy is insignificant.

  41. #41 Daedalus2u
    December 16, 2007

    You are correct. I appologize that I mixed up Chadwick with Bustin.

    It was Chadwick that provided the evidence of Wakefield’s results being contaminated which I believe is what wfjag was referring to:

    “The evidence presented in the Vaccine Court last summer is that one of the reasons for Wakefield’s bogus results was that his lab was contaminated with Measles virus from his own lab (DNA testing showing the virus to be the strain supposedly being used as a control, and neither a wild strain of Measles virus nor the strain used in the MMR vaccine), but that Wakefield’s lab techniques and standards were so deficient, he did not realize that his lab was contaminated, and that was the source of his findings.”

    Again, I mixed these two up. It would make no sense for Bustin to testify as his testimony was directed at the laboratory the Cedillo’s used. Chadwick is the one who’s testimony speaks directly to Wakefield’s procedures and ethics which is what he is on trial for.

    My question still stands for why Chadwick would not testify. He certainly took the time to testify in the Omnibus trial. I’m sure he got paid for that testimony, but I doubt he would be paid for the GMC hearing.

  42. #42 Schwartz
    December 16, 2007

    Posting too fast, and cutting pasting issues again. That last post was by me.

  43. #43 wfjag
    December 17, 2007

    Schwartz:

    “I would be careful about stressing the ‘voluntary’ nature of the recall though. I guarantee you that the regulators were well informed and aware of the situation, and I’ll wager that the contamination was severe enough that a ‘voluntary’ recall was easily negotiated.”

    No, I’m not implying an action based on altruism. Still, the manufacturer could tie up a government mandated recall for years. However, it has to weigh the costs and time of the proceedings, plus the time and expense of defending any suits filed, plus the loss of “good will” (used in the accounting sense of the term) by its customers, plus the PR black eye. Moreover, as possible contamination was identified, to not recall meant that the manufacturer would have to extensively test the vaccines to ensure that there was no contamination — and could never reach a 100% level of confidence. Finally, likely there’s insurance or other similar risk speading mechanism that the manufacturer has, and if the contamination can be traced, in whole or in part, to negligence by a contractor, or a contractor’s failure to follow standards set in its contract, the manufacturer can seek contribution or indemnity from such contractor. There’s a lot of factors militating in favor of a “voluntary” recall anytime a problem is identified.

    No, I didn’t depend on Autism Diva as my sole source. Orac responded to that. I also checked other sources, too. I am, also, aware “she is admittedly biased on the matter.” Everyone has biases (or points of view, or agendas — pick your term – the difference between a “bias” and an “opinion” depends on whether you disagree or agree with the speaker.) When a source’s biases (or point of view) are known, that helps in evaluating the source’s credibility on an issue. As for Wakefield and the Lancet article, that 10 of the 13 co-authors have signed a formal retraction of the article’s claims is, also, telling. See,
    http://briandeer.com/mmr/lancet-retraction.htm

    “I totally agree that the press combined with scaring people almost always leads to an overreaction. Unfortunately, the only alternative is hiding information from people, and that leads to a very slippery slope which can’t be justified ethically.”

    There’s another alternative — having science issues reported upon by reporters who have basic scientific competency, and who are willing to investigate the facts before rushing to report breathless allegations. This problem is hardly limited to reporting on scientific issues. See, e.g., MEDIA MYTHS ABOUT THE JENA 6 (OCT 24, 2006)www.csmonitor.com/2007/1024/p09s01-coop.html

    Granted, the author of that article lives in Jena, La, and is Asst. Editor of the local paper — so his assertions have to be taken with a grain of salt. Still, the Christian Science Monitor typically does a good job of fact checking, so there’s some assurance that the allegations have a substantial basis. However, the points of this illustration are (1) if even a few of the assertions are true, then what the major news reports presented about a story that received significant national coverage are reports of dubious accuracy; and (2) unless you’re willing and able to do considerable digging, it’s unlikely you’ll learn material facts about the story.

    Science stories are seldom so dramatic, and seldom receive nearly the coverage that the Jena 6 story did. How often do you think what you find “reported” are merely sensational simplifications? While you check blogs such as this one, and so obtain material information that isn’t otherwise reported, how many people have the time, knowledge and willingness to do so? Unfortunately, probably not many. Basic subject matter competence and verification of facts reported are, I believe, things we are entitled to from professional news organizations. However, too often, I believe we fail to receive those. One of the benefits of the alternative media of the blog-sphere, is that it is possible to identify sites which will present information that isn’t reported by the traditional news media. However, that doesn’t imply uncritical acceptance — everyone has (as you correctly noted) “biases.” And, while I don’t believe that Orca, Dr. Novella, Prometheus, or Autism Diva, to name a few, are “unbiased” (i.e., they all have opinions), I believe that all of them are much more credible than say, RFK, Jr., who was widely quoted and interviewed about the safety of the MMR vaccine because he published an article in Slate.

    I’m also paying attention to your thoughts, and thank you for them and the links.

  44. #44 Schwartz
    December 17, 2007

    wfjag,

    You’ll get full support from me for calling for informed science journalism as the current state of affairs is pitiful at best. I’ve stopped taking my national papers’ health column seriously, as they pretty much parrot the press release of any study they cover. That is not journalism, that is a headline service. The irony is that the columnist (actually pretty good on occasion) wrote an article covering a paper that highlight serious issues with health reporting today, and it hit the nail on the head as admitted by the newspaper. But no changes ensued, sigh.

    My bigger issue, is that without a competant independent press, it is extremely difficult to find an independent opinion, let alone proper analysis of the mostly industry funded research. Add to that the difficulty of actually getting reasonable access to the studies if you’re not in the industry (I’ve already spent a couple hundred dollars buying individual studies). I find it outrageous that the government mandates a medical narcotic or vaccine, yet does not force the manufacturer to make the safety information easily available to the general public for scrutiny.

    These blogs are a good source of debate and information, and yes, everyone has a bias and I suppose most people have an agenda too. I guess my minor complaint is that most of the blogs have a strong bias. There are very few that tread close to a purely objective viewpoint.

    The JFK’s et al, do perform a service of sorts though. Without them, a lot of people wouldn’t even be aware that a debate was going on and perhaps that is a small positive to be taken from the gross exaggerations that result. I am certain it causes at least a small number of people to seek out more information and attempt to inform themselves.

    The topic of Wakefield is obviously incendiary. I was aware of the retraction but I read your link and it confirms a little noticed detail that people tend to ommit. It was the study conclusion that the authors rejected. From the retraction, there is little mention of the methods or results in the study and this was confirmed by the biased account of the GMC hearing I’ve seen. The conclusion is certainly brash and expansive, but the science is what is being discussed during the trial currently underway. Again the testimony from the Omnibus trial that you referred to (Chadwick) has been notably missing in the UK — the proper forum to address issues with Wakefield — as it would apply directly to a discussion of the science and ethics involved.

    Again, in this case, we’re not getting independent coverage (only one biased account that I can find) but the coverage I have seen indicates the outcome is far from conclusive. I look forward to reading both sides after the verdict is in. I have given up hope for an independent account. I especially look forward to Brian Deer’s account, as he has a large stake in the outcome.

  45. #45 Schwartz
    December 17, 2007

    wfjag,

    I found more detail on the retraction:

    “We wish to make it clear that in this paper no causal link was established between (the) vaccine and autism, as the data were insufficient. However the possibility of such a link was raised, and consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper, according to precedent.”

    Note that the retraction is very specific and even gives the political fallout as part of the excuse for retracting the interpretation. The science itself was never retracted from what I can tell.

    No one ever talks about that detail and all references to the retraction imply that the whole thing was retracted. Apparently, there was a second study that was blocked from publication after the fallout and that second study was supposed to compliment the first. You also never hear about that either.

    Even a biased reading of the GMC trial has proven very informative.

  46. #46 wfjag
    December 18, 2007

    Schwartz:

    People like you — who take the time to try to investigate and analyze the facts and issues, and then provide reasoned, thought provoking comments — is the major reason I follow this blog. There are too many echo chamber blogs out there. Thank you for the responses.

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