Tuesday, April 20, 2010

Left Out - Hewitt's Explanation at Age of Autism

The comment as posted at Age of Autism  begins after the line of dashes.
  
August 24, 2010, added reference showing the definition of research in the US Regulations goes back to at least 1991 and added excerpts from the five sources.


Added April 23,2010.In case anyone doubts that my comment was saved at Age of Autism, here are pdf screenshots.


Added April 22, 2010,  I value honest debate highly and I've considered myself part of the skeptical movement from the time when Skeptical Inquirer was published in the weird small format. I know that others don't put the same value on debate. Yet, I'm still surprised at how desperately Age of Autism ensures there readers only learn of the approved facts. Actually, that's overkill by Age of Autism, because it very unlikely that what follows or anything else could change the mind of the faithful.

Martin Hewitt wrote and Age of Autism published  How the GMC Framed Doctors Wakefield, Walker-Smith and Murch, yet another defense of the three doctors. It does not explain why the GMC panel decided that the doctors had flouted the rules governing medical research. How the GMC Framed Doctors Wakefield, Walker-Smith and Murch by Martin Hewitt is better written than past attempts. I wrote a nice, polite comment on Hewitt's article and posted it at Age of Autism on April 20, 2010 at 7:54:01 pm. I wonder if it will be published. -------------------
Comment as Posted Starts Now
Hewitt's blog entry does not explain why the GMC decided that the only relevant ethical permission for The Lancet paper was 172-96, granted in January 1997. This comment explains the reasoning of the GMC.

If providing its reader with the most accurate information possible is a goal of Age of Autism, then this comment will be published.

This comment deals solely with whether The Lancet paper should be judged against the ethics committee approval from 1995 (162-95) or the January 1997 approval (172-96).   Hewitt and I agree that "the fitness to practice (FtP) panel faced the apparently small issue of  deciding which of two ethical approvals applied to the 1998 Lancet paper: approval 162-95 in 1995 or approval 172-96 in 1996 [should be 1997]. For the doctors, however, this one year's difference was momentous, even after 15 years of passing. The entire case would be won or lost on this one decision."

According to Hewitt, "The [162-95 approval] approval was generic and applied to children being treated by Walker-Smith. This included the Lancet case series of 12 children with autism and gastroenterological symptoms, a study describing clinical symptoms for which no research protocol was needed as the children were admitted for treatment -- ie they would be subject to the same tests whether or not they were included in the research study."

That's the defense of the three doctors to the ethics charges which Hewitt accepts:  They did not need Ethics Committee research approval because almost everything they did to the children was clinically indicated and 162-95 covered the tiny bit needing approval.

That definition is wrong. Worldwide, medical research is identified by the intent of the doctor. Is the doctor merely treating the patient or does the doctor have any plans to use the information gained from the patient for other purposes?  Does the doctor intend to take the information gathered from the patient, along with the information from other patients and generalize the information?   If the answers are yes, then the doctor is doing medical research and needs Ethics Committee (IRB in the US) approval in advance. Why is this definition used?  Because there can easily be a conflict of interest between the interests of the patient and the interests of the doctor.  In the references below is information from the UK, South Africa and the United States.

A classic example of intent requiring Ethics Committee approval  is planning to publish the results of tests and procedures. That was the plan of the three doctors from day one.  The charges against the doctor were designed to be as watertight as possible. Rather than asking the panel to make a general finding that the doctors had a general medical research intent, the panel was asked to decide if there was a research intent for each patient, for each doctor, when the child was admitted for a week of nasty scheduled tests and procedures.

Hewitt writes, "In cross examination the chair of the Ethics Committee [Dr. Pegg]  in 1995 and 1996 conceded that no EC approval was required to write up a retrospective case series for a journal. "  Dr. Pegg did say that.  But a retrospective case study means that you are not thinking of publishing or otherwise generalizing the clinical treatment of the patients. and that only when you have finished the tests and procedures on those you wish to include in a paper that you think, "Ah-ha, there is  something useful to others in what we did and that should be published."   That is a retrospective case studies for a journal.   That is not the situation here. Dr. Pegg made this clear when, according to Martin Walker, he testified  "[That] If the doctor concerned knew from the beginning of a case that he was going to write it up, then he needed ethical approval. If he did not initially intend writing up the case but did anyway, then he didn’t."**

With this 'intent' definition, it is easy to see why the three doctors were properly found to have been unethical because they were rightly judged against the 172-96 Ethics Committee approval of January 1997.


Five References to intent definition
The landmark US 1979 Belmont report section 'Boundaries Between Practice and Research"  

"By contrast, the term "research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective."  http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm#xethical

US Federal Regulations 45 CFR 46.102(d)   Unchanged from at least 1991 to the present
(d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
(http://www.hhs.gov/ohrp/references/comrulp2.pdf (1991)
 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102  (Current)

The Royal College of Physicians of London, August 1996."Guidelines on the practice of ethics committees in medical research involving human subjects"
"6.4. The distinction between medical research and innovative medical practice derives from the intent. In medical practice the sole intention is to benefit the individual patient consulting the clinician, not to gain knowledge of general benefit, though such knowledge may emerge from the clinical experience gained. In medical research the primary intention is to advance knowledge so that patients in general may benefit: the individual patient may or may not benefit directly.""  http://briandeer.com/wakefield/research-intent.htm

What is the South African Medical Research Council's ethics policy? (Web page last updated 2006) 
2.1.1 Clinical practice
When an activity is undertaken with the sole intention of benefiting an individual patient, and where there is a reasonable chance of success, that activity may be considered to be part of clinical practice. The progressive modification of methods of investigation and treatment, in the light of a clinician's experience, is a normal feature of clinical practice and should not be considered as research.

2.1.2 Research 
Research is a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalisable knowledge. Any such investigation raises ethical issues. The issues themselves may be small, but because studies may involve subordination of at least the immediate interest of the individual participant to the objective of the advancement of knowledge, they must be subject to ethics review.

2.1.3 Clinical practice and research
The distinction between clinical practice and research is often less clear than is suggested above, because both may be practised simultaneously on the same person. Any activity aimed at obtaining knowledge affecting a person in any way, and which is additional to ordinary clinical practice, is to be regarded as research (see also 7). A useful rule of thumb8 is that if this new knowledge is generalised or transferred to others, or presented at a scientific meeting, or submitted for publication or for a higher qualification, it is research.
http://www.sahealthinfo.org/ethics/ethicspolicy.htm 

Testimony of Dr. Pegg, Chairman  the Ethics Committee at the relevant times at the GMC Hearing in 2007 as  reported by Martin Walker
"A second key matter on which the defence was eager for commitment from Dr Pegg was whether a ‘case study’ - that is a clinical report of one or more similar cases – did or did not need ethical committee approval. On this matter, Pegg was hardly helpful to anyone. If the doctor concerned knew from the beginning of a case that he was going to write it up, then he needed ethical approval. If he did not initially intend writing up the case but did anyway, then he didn’t. This was a ridiculous explanation and one suspects it was made up on the hoof. What he probably meant to say, was that if individual children were examined for the sake of a scientific study then the doctor concerned needed ethical committee approval. If, however, all the children were seen on the basis of clinical need and at some point a number of the cases were written up, no ethical committee approval was needed."
http://www.cryshame.co.uk//index.php?option=com_content&task=view&id=48&Itemid=65&limit=1&limitstart=3










7 comments:

  1. Sheldon,

    Try as I might, I have asked this question over and over at many places and only ever received abuse or obfuscation. So I will ask you - after all what better place to ask this question than this website.

    How do vaccines work? How do T-cells, B-cells, antibodies, Q-cells or whatever they are called remember how to fight off either a pathogenic virus or bacteria and where is the in vitro evidence that they do?

    I asked this question at Orac's and on top of about a hundred responses of abuse I got one reference to a paper which only referred to a study done on non-living pathogens (presumably that means poison or venom although it didn't say).

    Please help.

    ReplyDelete
  2. It is all about time. You get exposed to measles for the first time and you aren't vaccinated almost certainly you will get the measles. However, while you have the measles the immune system creates memory cells that match the shape of the measles virus. Next time you get exposed to the measles, the memory cells are used to create enough cells to wipe out the virus before it can create enough copies to make you ill.

    The messles vaccine has the same effect and you end up with in a couple of weeks with an immune system that will destroy any wild measles strain you are later exposed to.

    That's incredibly simplified. As to proof that vaccines work in vitro, just google that and up come a lot of articles.

    There are course available on the internet you might look into. Here's one that has a chapter on vaccines.
    http://pathmicro.med.sc.edu/book/welcome.htm

    ReplyDelete
  3. I am sorry, but that in no way answers my question. How does the immune system create these memory cells?

    And telling me to consult google for the proof is pretty ordinary on your part. You don't think I have?

    As for the online course - are you serious?

    The fact is that I recently spoke to one of the top immunologists in my country (Australia) and he admitted that in actual fact they have no idea how the immune system remembers. Nor did he have an explanation as to why some viruses mutate so often (flu, HIV etc) and some never seem to mutate (measles, small pox) despite the theory of evolution (natural selection if you like) stating that mutations are random.


    And while you are answering these questions (properly if you don't mind this time) could you provide an explanation as to how it came to be that ever since the polio vaccine was introduced a brand new disease - viral meningitis - cropped up out of nowhere and started infecting large numbers of people with the same symptoms as did polio (of course bacterial meningitis was diagnosed before that). Isn't that an astonishing coincidence? And is it also an astonishing coincidence that the exact same phenomena occurred with diphtheria (increases in severe tonsillitis), small pox (severe/fatal chicken pox), bacterial meningitis (different strains of bacterial meningitis)?

    Just wondering. I know that vaccines work but it troubles me that these things could have happened after vaccination and that evil anti-vaccine lunatics might use these as evidence that the whole thing is a sham. Could you please put my fears to rest by providing the explanation as to how it is that every one of the vaccine success stories seemed to be coincidentally replaced by some other disease with the exact same symptoms?

    Thanks in advance.

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  4. If one of the top immunologists couldn't answer your questions satisfactorily, what are the chances that someone who never took high school biology will do better?

    I think you're arguing that vaccines don't work. And that the disease continues under a new name. Remembering that this type of research is carried out worldwide, it no longer is difficult to determine how long one virus broke off from another.

    For example, "Using HIV-1 sequences preserved in human biological samples along with estimates of viral mutation rates, scientists calculate that the jump from chimpanzee to human probably happened during the late 19th or early 20th century, a time of rapid urbanisation and colonisation in equatorial Africa."
    http://en.wikipedia.org/wiki/Origin_of_AIDS



    If you want, consider asking your questions on mutation and continuing disease/different name to TWIV. I heartily recommend the podcast and they do eventually answer email.

    ReplyDelete
  5. Who or what is TWIV?

    At any rate I fail to see how your third para provides evidence for the statement that it is easy to determine the path of a virus. The wiki quote is nothing more than a guess. What is more, it is a guess based on their presumed belief about what causes AIDS - ie a virus. This is why science is so appalling at the moment. Scientists don't use observations to develop a theory they use their preconceived theory to contrive observations. A classic one is the notion that outbreaks of measles (or similar) are caused by unvaccinated children. This is a convenient - and completely baseless - explanation. Doctors have absolutely no idea how the disease spreads, and they certainly don't observe viruses/bacteria jumping from one person to another. However, their preconceived theory tells them that unvaccinated children are dangerous and this is how they interpret events. So if 1000 kids get measles and one of them is unvaccinated then that kid gets blamed - without the slightest shred of evidence whatsoever. Simply because it is consistent with doctors' beliefs and it enables them to cast certain people in a bad light.

    I find your statement in the first para quite amazing. You have a website that is titled - vaccineswork. You would think the revelation that an immunologist has absolutely no understanding of how they do would give you pause for concern that maybe this whole thing is a complete crock. Of course you might think I am lying and every immunologist knows exactly how they do, but then wouldn't the information be out there available and wouldn't a guy with a website devoted to the wonders of vaccines know about it regardless of his high school biology record? I never took much biology either. But unlike you I ask questions, I don't simply blindly assume that experts must be right just because they agree with each other.
    I ask doctors/scientists a bunch of simple questions. For example, if we are supposed to ignore the correlation between the rise in autism, allergies, asthma, diabetes, arthritis, gastor issues, earaches etc and the increase in vaccinations because correlation doesn't prove causation, then how can we use the fact that polio incidence fell after vaccination as proof that the polio vaccine worked? Why does correlation prove causation for one but not the other? This question has never been answered. Nor has the question that I posed to you before about the renaming of the same disease been answered. The medical community don't like these questions and doesn't want them to be asked. Nor do they want people to ask the question as to why there are some people out there with disease symptoms and no corresponding pathogenic virus/bacteria or virus/bacteria but no corresponding disease symptoms? That is a nuisance for doctors too.

    Here is my advice Sheldon. You actually seem like a really nice bloke (as distinct from Orac and most in the so-called skeptic community (they seem remarkably non-skeptical of authority)) so given that you don't understand how vaccines work you should take a hiatus from your blog. Research how they do and either come to the conclusion that I have - which is that the whole thing is a complete lie - or find the answer and post it on your site. That should be the minimum you should do. Find some explanation as to how vaccines could possibly work (even in theory) find some evidence that they do (physical evidence (ie in vitro)) and while you are at it you may as well try and answer the other questions that I have posed. If you are anything like me you won't even be able to answer the first, let alone the subsequent questions. But maybe you are better at research than I am and you know to ask and what are the right questions. Frankly I hope that you succeed. I really wish a little pin-prick would protect my children from all manner of dread diseases. I just can't find any reason to think that it is so.

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  6. Top result from Googling TWIV This Week in Virology.

    I think that's about all I'm going to say in reply to you.

    ReplyDelete
  7. Nice blogging, My review is very good example.
    Lindsay Rosenwald http://www.lindsayrosenwald.biz/lindsay-biotechnology/dr-lindsay-rosenwald-leader-drug-development/ Dr. Lindsay Rosenwald- A Leader of Drug Development

    ReplyDelete