Doc Who Tied Vaccine To Autism Was ‘Unethical”
108 CommentsBy Ed Silverman // January 29th, 2010 // 7:35 am
The doctor who first suggested a link between MMR vaccinations and autism acted unethically, the official medical regulator has found. Andrew Wakefield’s 1998 study in The Lancet caused vaccination rates to plunge, resulting in a rise in measles, although the findings were later discredited, the BBC reports. The General Medical Council ruled he had acted “dishonestly and irresponsibly” in doing his research (back story).
Afterwards, Wakefield said the claims were “unfounded and unjust…and that the science will continue in earnest.” The GMC case did not investigate whether Wakefield’s findings were right or wrong, instead it was focused on the methods of research. The panel said Wakefield, who was working at London’s Royal Free Hospital as a gastroenterologist at the time, didn’t have the ethical approval or relevant qualifications for such tests.
The GMC also took exception with the way he gathered blood samples. For instance, Wakefield paid children 5 pounds for samples at his son’s birthday party. Panel chair Surendra Kumar said Wakefield acted with “callous disregard for the distress and pain the children might suffer,” and that he should have disclosed that he had been paid to advise lawyers acting for parents who believed their children had been harmed by the MMR.
UPDATE: On Feb. 2, The Lancet retracted Wakefield’s research and issued this statement: “Following the judgment of the UK General Medical Council’s Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al are incorrect, contrary to the findings of an earlier investigation. In particular, the claims in the original paper that children were ‘consecutively referred’ and that investigations were ‘approved’ by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.”
patrons99
From where I stand, Wakefield is a hero. This is a witch hunt much like the “inquisition” that the WHO is revving up in defense of its indefensible handling of the H1N1 “pandemic”, calling those few brave dissident voices “irresponsible”.
I suspect that Florence Nightingale, more than a century ago, was attacked in much the same way that Wakefield has been. Anyone who ever raises serious questions as to mainstream medical doctrine is made an outcast and labeled a pariah, e.g. Andrew Moulden.
“The specific disease doctrine is the grand refuge of weak, uncultured, unstable minds, such as now rule in the medical profession. There are no specific diseases; there are specific disease conditions.” - Florence Nightingale, circa 1860
Pharma has an enormous vested interest in global healthcare policy. The global healthcare puppet masters, Pharma and the WHO, have no interest whatsoever in a “philosophical exemption for vaccinations”.
For a cogent medicolegal perspective on this topic, A cogent medicolegal perspective is provided by Mayer Eisenstein, M.D., J.D., M.P.H. in a video presentation titled “Don’t Vaccinate before You Educate”.
http://homefirst.com/info-1/vaccine-choice.html/?___store=default
http://www.vaccineinfo.net/releases/parent_groups_support_texas_law.shtml
We may be stuck in a rut from which we cannot extricate outselves unless we are willing to consider that some long held medical doctrine may, at least in part, be wrong.
There is a tacit assumption by the WHO that vaccines are a social good. This assumption may be wrong. Is it irresponsible to raise concern as to whether there may be a downside to a global program of serial immunizations from cradle to grave? It is irresponsible to raise concern as to whether there might be cummulative, synergistic toxicity of the metals, adjuvants, preservatives, and uncertain biologic recombinants, found in many of the vaccines administered over a lifetime, which begins in childhood?.
Before we are committed to a path from which there may be no return, might it be reasonable to critically examine whether vaccines are truly effective and safe, rather than just accepting it on faith. There may be something fundamentally wrong with a theory that says, in effect, that we should be vaccinated serially to prevent infections by every potential pathogen on the planet, both new and old, including every mutated and evolved pathogen.
Stephanie
Couldn’t agree with you more patrons99! And NJ is the worst holding our children’s education hostage unless we vaccinate them to the hilt!
patrons99
Yikes! Sorry for the typos and cut and paste errors.
JR
My kids no long wake up in the screaming in pain because thanks to the research Wakefield has courageously pioneered.
For the GMC to say that he was “callous to the suffering of children” because he paid kids $5 for blood samples at a birthday to use as controls shows what a biased fraud this was. Wakefield was one of the first docs to recognize and treat the suffering of kids with autism, an act which even the not-so-autism-friendly AAP now endorses.
ethical?
compared to what?
http://clinicaltrials.gov/ct2/show/NCT00988533
Cindy
Andy Wakefield is brave indeed and has earned my greatest respect.
When my child was diagnosed with autism nearly a decade ago, I refused to believe that vaccines were responsible. I was a typical parent who trusted the CDC, the FDA, and the AAP. As my child got physically sicker, I began to investigate the vaccine connection. I was SHOCKED by the poorly designed and executed studies that supposedly exonerate vaccines. Whenever I’ve asked a physician or journalist about these studies, invariably they haven’t read them. They simply place their full trust in the powers that be and push the party line.
Fast forward 8 years. Thanks to biomedical treatment to address the underlying causes of my child’s ASD, she has made enormous progress. Sleep disturbnces, gone. Chronic constipation, gone. Frequent colds/viruses, gone. Hyperactivity, irritability, volatility, gone. Eye contact, restored. Happy mood, restored. Cognitive function and communication skills, vastly improved. The list goes on …
I hope I live long enough to witness the day when the so-called quacks are given the respect they deserve. I will NEVER place blind faith in any organization again.
Kudos to Dr. Wakefield for actually giving a damn about our kids. He’s paid a hefty price.
pharmavet
Just a few excerpts from the January 29 UK Daily telegraph, reporting on the GMC investigation of Dr. Andrew Wakefield and colleagues
“If we have research ethics approval systems for anything, then it is to protect vulnerable people from unwarranted onerous research interventions and experiments – and I can think of few more vulnerable groups in our society than autistic children and their distressed parents”.
Dr Evan Harris, Liberal Democrat MP, who has previously been a member of the research ethics committee in Oxford, said: “That the GMC has found Wakefield guilty of unapproved and unnecessary invasive tests, including spinal taps, on young children, is the most damning indictment possible. The findings of failure to declare financial interest are a secondary consideration.”
“In researching links between autism, bowel disorders and the measles, mumps and rubella vaccine he ordered unnecessary invasive tests on children without proper ethical approval”.
“Children were enrolled in the study who should not have been and were subjected to tests including brain scans, colonoscopies and spinal taps, that were not justified or necessary, the panel said”.
“In March 1999, at his son’s birthday party, Dr Wakefield paid children to have blood taken for the research, later describing the event in humours terms, Dr Kumar said”.
He added: “You showed a callous disregard for the distress and pain that you knew or ought to have known the children involved might suffer.
“The Lancet article should never have been published, and its peer review system failed. The article should now be expunged from the academic record, and journals now need to check that experiments described in submitted papers actually match the research protocol which was given ethical approval.”
“It is tragic that the otherwise distinguished careers of Prof Walker-Smith and Prof Murch have been dragged down by their insistence on trying to stand or fall with Dr Wakefield.”
“Shadow Health Secretary, Norman Lamb said: “The impact of Dr. Wakefield’s conduct on public health in this country has been profoundly and deeply damaging”.
“The dramatic decline in take up of the MMR vaccine resulting from unfounded fears generated by Dr. Wakefield have set back this key health initiative in the most serious way”.
“This has been a long, drawn out process. The critical thing now is to rebuild public confidence and finally lay to rest the suggestion that children’s health is at risk from this vaccine.”
elmore
I wonder which would be the greater trauma-getting 5 pounds for voluntarily giving blood, or having autism?
There’s a lot I don’t know about this, but wasn’t there some indication that giving vaccinations singly rather than in groups was a better route? If that’s the case, I wonder why that is not done routinely.
Josh
So doing research in which you are going to be an expert witness isn’t a conflict of interest?
patrons99
Pharmavet,
Rather than focusing this discussion on an ad hominen attack upon the messenger (as the mainstream media is doing), why not let the facts as to vaccine safety, speak for themselves?
Personally, I maintain that the issue as to risk from ALL vaccines is far from settled. Does this make me “irresponsible”?
Here is a copy of the package insert for the MMR vaccine:
http://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf
The MMR vaccine is made from chick embryo and aborted human embryo tissue. Side effects include diabetes, arthritis, deafness, Guillan Barre Syndrome, and death. It has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.
harry
This is a classic pharma counter-attack. The General Medical Council are no angels. General election in the UK, May/June so politicians have to be careful.
pharmavet
The link below is to the UK General Medical Counsel and their Conflicts of Interest, which they are required to declare per Code of Conduct. I don’t see any glaring COI’s, although perhaps someone from or with knowledge of UK affairs could better comment. Harry, you seem to know something since you say that the GMC “are no angels”. Perhaps you could explain further.
http://www.gmc-uk.org/about/council/register_interests.asp
Lisa Van Syckel
Elmore,.. I wasnt aware that they gave them singly either, I learned about this after my daughter told me that, that, is how my grandson receives his, and if I remember correctly, they have to be specially ordered.
harry
Niall Dickson, is the CEO. Previously employed by The King’s Fund’s and the BBC (reason why BBC is promoting this junk)
look up the The kings fund’s…
“The IMPACT Awards have been running since 1997 and are designed to recognise and reward charities that are doing excellent work to improve people’s health. They are funded by GlaxoSmithKline and managed in partnership with The King’s Fund. The awards are open to registered charities that are at least three years old, working in a health-related field in the UK, with a total annual income between £10,000 and £1 million.”
That says it all!
Reality Check
This article turns out to be an interesting Rorschach test for all of those who regularly blast pharma for conflicts of interest, poor research, etc. Clearly, Wakefield has been shown to have conducted unethical and poorly constructed research. Moreover, he had a blatant unreported conflict of interest. Finally, it has been proven that the science is not on his side (at least according to every study conducted since his tiny study was published and then withdrawn and according to every mainstream science group in the UK and the US). These are all activities for which patron99 and others excoriate pharma, yet you patrons99 leap to Wakefield’s defense. This simple demonstrates that you are no better leap to pharma’s defense. Moreover, your creative use of scientific misinformation and you blatant hypocrisy I think your position is actually worse.
Christopher
The original story concerns the way that Wakefield conducted his research and whether he was qualified to perform it, not the outcome. That is what the case was about and why he was reprimanded. The GMC is there to oversee and administer proper standards in medicine. If his study had been performed by a pharma or biotech company I assume there would be similar recriminations and no complaints here.
pharmavet
Reality Check, I don’t know if this is your first post, but be prepared to be blasted between thew eyeballs by the anti-pharma crowd on this site. My rough calculation indicates that you and I are outnumbered 10/1, although statistically you just halved that ratio. Still we are vastly outnumbered. Since this is a UK centric piece, my only suggestion is to keep a stiff upper lip. I’m sure you can handle it.
Yours in Solidarity,
Pharmavet
Evelyn Pringle
Wakefield’s attackers have a great advantage because unless a person has a month to spend researching this issue, a defender cannot come to his defense.
I say this because back in 2004 and 2005, I did spend months researching the vaccine-autism matter and I should have retained enough info to jump in and defend Wakefield. However, the matter is so complex that I don’t know where to begin, especially in a short blog.
But in regard to destroying anyone who poses a threat to the vaccine industry, I would advise people to review the history of other industries, such as the concealment of harm caused by tobacco, lead and asbestos.
Robert
Could be a smear campaign, though. Big Pharma has tried things like this before.
Christopher
Putting aside talk of smear campaigns, wilful destruction of reputations and the like, can anybody share how the GMC was brought into this in the first place? I can’t find the source but, as I said above, the purpose of the GMC is to oversee good medical practice. That assumes impartiality and adherence to established guidelines. It seems that Dr Wakefield did not follow such guidelines. I don’t see anywhere comment from the GMC as to whether they agreed with his findings. I’d be interested to see how they were influenced to kill this particular messenger. Thanks for any insight.
patrons99
Reality Check,
“your creative use of scientific misinformation and you blatant hypocrisy”. You offend me, Sir. I will not dignify your post with a specific response.
I would simply ask that read the article titled, “The Danger of Overvaccination with the Present Vaccine Policy” by Dr Russell Blaylock, M.D., of March 2007.
http://www.thenhf.com/vaccinations_125.htm
Lisa Van Syckel
Christopher,
This issue has always baffled me, cant make heads or tails of it all. Would love to hear from Dr. Wakefield and the GMC, would be good for them to further elaborate the issue,..yes?
Christopher
Lisa,
I imagine that complaints can be brought to the GMC anonymously or overtly, so perhaps there is room for abuse - if that’s the word - by those with an agenda who wish to drive a case which might benefit their cause. However, that does not mean the GMC would operate with anything but objectivity in assessing the case.
This may be extreme but this story makes me think of today’s trial of the killer of the abortion doctor in Kansas. The case was to determine whether Roeder, the defendant, was guilty of murder and yet the issue became (inevitably) about abortion and the impact of his beliefs in right to life on his actions. As you will know the case attracted impassioned protesters of both persuasions and took on a very high profile. And yet the case in question was not about the rights and wrongs of abortion, but a matter of law.
I can understand the passion and genuinely strong feelings of the anti-vaccines people, but can also see how that strong feeling can distract from the real issue under consideration which, again, is whether Dr Wakefield undertook research in an inappropriate way and failed to disclose COI.
JR
The complaint was brought by a reporter, Brian Deer.
No parent of the scoped children complained that they were used or exploited by Dr. Wakefield. In fact, they are still standing by him.
It’s like doing an MRI, finding cancer, treating the cancer and then being charged for ordering an unwarranted MRI by someone other than the cancer patient who is grateful for your treatment. A witch hunt indeed.
harry
two debates, wakefield debate and the vaccine debate.
wakefield took blood samples from kids in exchange for five pounds and other invasive techniques which he received ethics approval for he maintains.
it took the GMC 2 1/2 years and 1 million pounds or 2 million dollars to come up with the verdict against wakefield. Despite the cost the GMC added no helpful information to the vaccine debate.
He was unethical, strike him off the medical register then, no problems with that. we have seen much worse breaches of ethics since then. Pfizer in Nigeria for instance, can’t strike Pfizer doctors off the global medical register though!
anyway, the vaccine debate hasn’t changed. parents still have unanswered questions and rightly so.
Why don’t the GMC investigate Dr. Ian Hudson of the MHRA and paxil scandal fame. Shouldn’t Dr. Hudson be struck off the UK medical register. Evan Harris could do the honors and file the complaint? But wait Mr. Hudson was in the employ of GSK so he receives immunity from the GMC/GSK investigators. conflict of interest I suppose!
Christopher
harry - don’t understand why working for a company (GSK) would make a physician immune if (s)he had done anything that warranted investigation and punishment. Not sure I understand how or why that would work.
Lisa Van Syckel
I think JR just answered the question I had, and that was what did the parents think, and did they approve. Bazzaare!!! if you ask me.
Christopher, My take is this, folks really do need to stay out of the private lives of women and their families, and the guy who killed the Doctor, got what he deserved.
Reality Check
I guess Time Magazine must be part of the conspiracy: http://www.time.com/time/health/article/0,8599,1957656,00.html.
Here are some quotes:
“Wakefield’s study has since been discredited, and the MMR vaccine deemed to be safe….The panel’s ruling follows a refutation of Wakefield’s research from the scientific community. Ten of 13 authors in the Lancet study have since renounced the study’s conclusions. The Lancet has said it should not have published the study in the first place, and various other studies have failed to corroborate Wakefield’s hypothesis….Despite this, the effects of the media frenzy surrounding Wakefield’s research — a study found that MMR was the most written about science topic in the U.K. in 2002 — continue to be felt in Britain. Vaccination rates among toddlers plummeted from over 90% in the mid-1990s to below 70% in some places by 2003. Following this drop, Britain saw an increase in measles cases at a time when the disease had been all but eradicated in many developed countries. In 1998, there were just 56 cases of the disease in England and Wales; by 2008 there were 1,370.”
Of course, you can go to the the Times of London and read the history of this scandal since its reporter, Brian Deer, broke the story. That stories newspaper must also be part of the conspiracy along with the NY Times, AP, etc. Of course, these are all known to be pharma-friendly, right?
This isn’t some smear campaign, but a serious case of malpractice that has resulted in significant morbidity and mortality. If a pharmaceutical company was behind this, patrons99, Condor, Former, and others would be calling for congressional investigations and jail sentences.
Jan Henderson
“[Y]our creative use of scientific misinformation.” Ah, but that is precisely the nature of scientific and health information in the media today. “Doubt is our product.” Tobacco. Global warming. Vaccines. Mammograms.
An excellent book, which includes a chapter on Wakefield, is Ben Goldacre’s Bad Science. Goldacre is a British MD who writes for The Guardian. He argues that the media is to blame for the MMR scare, not just Wakefield.
“Wakefield was at the centre of a media storm about the MMR vaccine, and is now being blamed by journalists as if he were the only one at fault. In reality, the media are equally guilty.
“Even if it had been immaculately well conducted – and it certainly wasn’t – Wakefield’s “case series report” of 12 children’s clinical anecdotes would never have justified the conclusion that MMR causes autism, despite what journalists claimed: it simply didn’t have big enough numbers to do so. But the media repeatedly reported the concerns of this one man, generally without giving methodological details of the research, either because they found it too complicated, inexplicably, or because to do so would have undermined their story.
“As the years passed by, media coverage deteriorated further. Claims by researchers who never published scientific papers to back up their claims were reported in the newspapers as important new scientific breakthroughs, while at the very same time, evidence showing no link between MMR and autism, fully published in peer reviewed academic journals, was simply ignored. This was cynical, and unforgivable. Then, after Tony Blair refused to say if his son had received the vaccine, the commentators rolled in. … The media have developed no insight into their own role, and for this reason, there will be another MMR.”
Christopher
JR - respectfully, I think it’s not like doing an MRI, finding and treating cancer etc. Based on what I understand from the article it’s more like doing a lumbar puncture in kids with unexplained seizures, finding say, antibiotics in their csf, and deciding that those drugs are causing the seizures.
Thanks for identifying the journalist btw.
Casey
What was the GMC’s reason for not investigating Dr. Wakefield’s findings? Vaccinations are an important issue; they are the cause of stress for a lot of parents– many of whom are having their children home schooled just to avoid such injections. We need honest answers, but how are we going to get them when someone who challenges the status quo is made to look “unethical?” Is that good science, or good marketing?
Reality Check
Casey,
The science was discredited a long time ago. His study included a grand total of 12 kids. Moreover, his case reports didn’t match records from physicians and hospitals. A number of larger, well conducted studies have refuted all of his findings to the point that no credible expert or government organization in the UK or US gives it any relevance.
Elaine
I’ll take my vaccination(s)if I can have assurances a latex-free (i’m allergic)glove wearing doc who changes gloves between patients already gave it to his family, that it has never been touted as entirely safe or advertised on television or pharmacy parking lot billboards — that it is labeled accurately and with all ingredients disclosed to me in advance, administered with a never-before-used sterile glass syringe and needle (no plastic with bisphenol-A and/or phthalates thank you)with the pre-loaded dose sans mercury and aluminum, with ingredients maintained, manufactured in US and stored securely at the proper temperatures without fail from start to finish all the way up until it becomes part of my DNA.
BTW:
USA Today - 5 hours ago
Bill Gates commits $10 billion for vaccines over the next decade
Bill and Melinda Gates gave a big hat tip to vaccinations today at the World Economic Forum in Davos, Switzerland. Indeed, the pair, who head up the Bill …
Cindy
Reality Check,
Would you provide citations for the number of larger, well conducted studies so I can read them? Thanks.
pharmavet
I can speak from experience attempting to do clinical trials with endoscopies in small children, having directed a number of GI studies. I can tell everyone flat out that unless you are doing a study of a SERIOUS illness, i.e. cancer, pediatric ulcerative colitis, etc., no reputable IRB in the United States would ever approve a clinical trial protocol exposing childrenn to the rigors and risks of endoscopy of any sort. I have had entire protocols which were otherwise clean refused simply because they included childhood endoscopy. Dr. Wakefield would never have been able to obtain IRB approval in the United States (again I emphasize reputable; I can’t speak for the less reutable commercial IRB’s). I don’t believe that Dr. Wakefield would have been able to obtain approval of childhood endoscopies by a reputable IRB in any country with a developed civilization and respect for the rights and safety of childhood study subjects.
Reality Check
Cindy,
No IRB would ever approve any sort of a head to head trial; it would be unethical. However, there are a multitude of independent analyses, mostly case controlled that all say the same thing. Here is a sample:
Hornig M, Briese T, Buie T, Bauman ML, Lauwers G, et al. 2008 Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study.
Lack of Association Between Measles-Mumps-Rubella Vaccination and Autism in Children: A Case-Control Study.
Mroek-Budzyn-Dorota, Kieltyka-Agnieszka, Majewska-Renata.
The Pediatric infectious disease journal, {Pediatr-Infect-Dis-J}, 1 Dec 2009 (epub: 1 Dec 2009), ISSN: 1532-0987.
Lack of association between measles virus vaccine and autism with enteropathy: a case-control study.
Hornig-Mady, Briese-Thomas, Buie-Timothy, Bauman-Margaret-L, Lauwers-Gregory, Siemetzki-Ulrike, Hummel-Kimberly, Rota-Paul-A, Bellini-William-J, O-Leary-John-J, Sheils-Orla, Alden-Errol, Pickering-Larry, Lipkin-W-Ian.
PloS one, {PLoS-ONE}, 2008 (epub), vol. 3, no. 9, p. e3140, ISSN: 1932-6203.
Fombonne, E. & Chakrabarti, S. No evidence for a new variant of measles–mumps–rubella induced autism. Pediatrics 108, E58 (2001).
Taylor, B. et al. Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association. Lancet 353, 2026–2029 (1999).
Chen, W., Landau, S., Sham, P. & Fombonne, E. No evidence for links between autism MMR and measles virus. Psychol. Med. 34, 543–553 (2004).
Honda, H., Shimizu, Y. & Rutter, M. No effect of MMR withdrawal on the incidence of autism: a total population study. J. Child Psychol. Psychiatry 46, 572–579 (2005).
Madsen, K.M. et al. A population-based study of measles, mumps, and rubella vaccination and autism. N. Engl. J. Med. 347, 1477–1482 (2002).
DeStefano, F., Karapurkar, T., Thompson, W.W., Yeargin-Allsopp, M. & Boyle, C. Age at first measles–mumps–rubella vaccination in children with autism and school-matched controls: a population-based study in metropolitan Atlanta. Pediatrics 113, 259–266
Smeeth, L. et al. MMR vaccination and pervasive developmental disorders: a case–control study. Lancet 364, 963–969 (2004).
Verstraeten, T. et al. Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases. Pediatrics 112, 1039–1048 (2003).
Cindy
For anyone who’d like a deconstruction of these studies or to read them yourself, try fourteenstudies.org.
Josh
Cindy, out of curiosity could you provide actual clinical studies that prove that vaccines cause autism?
The problem is that other factors could come into play, because if vaccines were truly causing autism, then it should be more widespread than the current percentage.
patrons99
As Harry points out earlier in the thread, “two debates, wakefield debate and the vaccine debate.”
A very succinct enunciation of the risks of ALL vaccines is found in an article of December 2009, by Russell Blaylock, M.D. titled “Forced Vaccinations, Government, and the Public Interest”.
http://www.thenhf.com/vaccinations/vac_299.htm
Cindy
Josh,
I can’t point them out because there none. Neither are there clinical studies that prove the opposite. The evidence on both sides has been largely epidemiological.
The etiology of autism is likely genetic predispositions combined with environmental triggers. As Bernadine Healy has noted, what’s necessary is a study on 300 or so kids with autism that includes complete medical testing. Let’s look at the immune system, gastrointestinal system, functional MRIs, etc. Once we know what’s actually happening in their bodies, perhaps we can find commonalities and look for actual risk factors. Genetics alone CANNOT explain the rapid increase in the disorder. And the nonsense about doctors getting better at diagnosis cracks me up. Ask any parent how long it took for them to get an actual diagnosis. The current 1 in 110 numbers are based on kids who were born in 1996, the year my child was born. It took us almost two years and a series of docs to get to a diagnosis of PDD. At the time, the developmental ped who diagnosed did us a big favor. She told us not to look to the medical community for treatment modalities because they knew very little about autism. She said it would be up to us as parents to figure it out. It was frightening but she was right.
I’m not anti-vaccine. First, my child was fully immunized according to the CDC’s schedule. Second, if I had to do it again, I would immunize but on a different schedule and I’d leave a few out (HepB, Varicella). I’d also separate the MMR into 3 shots (which BTW is what Andrew Wakefield actually suggested until further studies could be done). But the current vaccine schedule hasn’t been studied. The vaccines are studied as administered singly. My child had vaccines against 8 diseases at one time. How do we know what that does to an infant’s immune system? We don’t because nobody’s ever studied it.
I’m not going to change anyone’s mind so these comments are probably an exercise in futility. And Harry and patrons99 are right about the two distinct debates. This probably isn’t the appropriate venue for the vaccine arguments. I’ll end by saying that no child should have to endure the very real physical suffering that many of our children have endured. Until researchers with no conflicts of interest can credibly tell us why and explain how it can’t possibly be the aggressive vaccine schedule, we parents will continue to question. We would be negligent in our duty as parents if we didn’t.
pharmavet
This year marks the 65th anniversary of the liberation of the Auschwitz Nazi death camp. The blatant disregard for the rights and safety of children by Dr Andrew Wakefield reminds me of the camp “doctor”, Dr. Josef Mengele. Wakefield and Mengele used somewhat similar recruiting methods to lure unsuspecting children into their studies. Mengele used sweet chocolate. With Wakefield, all that was needed was a crisp five pound note.
Justice in MI
Vet–It happens that I’ve been teaching and writing about the Holocaust for more than thirty years. So this is something I actually know about.
I don’t know anything about the Wakefield case (beyond what I read here) and have not done the background work to make any judgment. So I’ll leave that one alone.
What I will say is this:
If Wakefield did what he is accused of, it is, indeed, heinous. I’m not sure it’s at a different level, though, than say Lilly or AZ covering up risk data about Zyprexa or Seroquel in order to market them more effectively to kids. It’s using kids’ lives for one’s own ends either way–whether commercial or whatever else.
On this anniversary, we should probably also recall that Auschwitz III (the section where Elie Wiesel and Primo Levi were imprisoned) was operated by I.G. Farben. Farben was two-thirds pharma–Bayer AG and Hoechst (now Aventis). And, indeed, as those companies have acknowledged–willingly and, at times, begrudgingly–their medical experiments on Auschwitz prisoners was precisely what you accuse Wakefield of doing, but it was on an enormously larger scale, for profit, and supported by the SS and wider regime.
So it is, indeed, a time to reflect on what we have, and have not, learned from Auschwitz.
Justice in MI
Perhaps also worth saying that the kids Mengele “lured” were the lucky ones. The vast majority of kids who arrived at Auschwitz he and his colleagues simply gassed and burned.
Christopher
Poor comparison pharmavet and way out of proportion. Often I agree with you.
Christopher
Making any connection between what Dr Wakefield supposedly did and what happened in Auschwitz - or insinuating into that context a reference to pharma companies - is utterly inappropriate and way off this particular topic.
Christopher
Update from journalist Brian Deer at Times (UK) Sunday edition.
Link here http://tinyurl.com/yla96zg
pharmavet
Sometimes extreme comparisons must be drawn in order to draw people’s attention, even if the analogies may be off target, which I readily admit.
Nancy
According to the BBC Profile for Andrew Wakefield, dated 01/27/10, “…[Dr. Wakefield] continued to see patients at the Thoughtful House, a centre for autistic children in [Austin] Texas, where he is currently the executive director.”
A search of the Texas Medical Board’s automated medical license records on 01/30/10 produced no record for Andrew Wakefield.
A search of ClinicalTrials.gov revealed Andrew Wakefield directed a study of hyperbaric oxygen therapy for children with autism from 11/2006 to 08/2009 [NCT00406159]. According to the History of Changes, Jerrold J. Kartzinel, MD, was the Principal Investigator, and the last actual study follow-up date was 12/2008.
The Texas Medical Board’s automated medical license records reflected the following licensure information for Jerrold Jay Kartzinel, MD:
License issued: 02/03/2006
Delinquent non-payment: 05/04/2006
Active: 08/14/2006
Expiration Date of Physician’s Annual Registration Permit: 02/28/2008*
Delinquent non-payment: 03/29/2008*
Inactive: 10/04/2008*
Cancelled by request: 03/01/2009*
A statement on Thoughtful House’s Web site reflected “Informed consent is a crucial element of the foundation upon which ethical medical practice rests. Providing patients, parents, or guardians with an honest assessment of the risks and benefits of any medical procedure requires the physician to be, to the best of his or her ability, ‘informed.’
Andrew J Wakefield, MB, BS, FRCS, FRCPath”
http://tinyurl.com/yc3cqqy
Nancy
A search of ClinicalTrials.gov revealed that Bryan Jepson, MD, (one of Dr. Wakefield’s colleagues) is currently conducting a study of antifungal therapy for children with autism [NCT00936182].
A search of the Texas Medical Board’s automated medical license records on 01/30/10 revealed the medical board took the following action against Bryan Jepson on 12/19/05:
“…[JEPSON] HAS BEEN ISSUED A TEMPORARY LICENSE UNDER A NON-DISCIPLINARY PUBLIC AGREED ORDER. THE ORDER REQUIRES THE PHYSICIAN TO PAY AN ADMINISTRATIVE PENALTY IN THE AMOUNT OF $1,000.00 WITHIN 30 DAYS AFTER ENTRY OF THE ORDER. THIS PENALTY WAS ASSESSED DUE TO THE PHYSICIAN REPRESENTING HIMSELF AS BEING ENTITLED TO PRACTICE MEDICINE IN TEXAS ALTHOUGH A MEDICAL LICENSE HAD NOT AS YET BEEN ISSUED.”
The licensure record for Dr. Jepson included the following information:
Temporary license issued under board order: 12/21/2005
Permanent license issued under board order: 02/03/2006
Delinquent non-payment: 05/04/2006
Active 08/17/2006
patrons99
Thank you, Christopher, for injecting some sanity back into this discussion. Talk about a “rush to judgment”. Some ideas are worth dying for, e.g. freedom, justice, fairness. To be comparing Wakefield to Mengele, seems far beyond the pale, given that he’s not here to defend himself against these accusations. While I am not privy to the details surrounding Wakefield’s research, I concede that if he did violate the Declaration of Helinski and/or the Nuremberg Code, he should face a reckoning. I don’t have enough information to know whether he did or did not violate these ethical codes. It does sound to me, as though the press is hell-bent to destroy the man, and by destroying the man, destroy his work. Why now?
Reality Check
Patrons99, why now you ask? Because this man is killing kids through misinformation. Measle rate in the OK have climbed by more than 20 times. Some of these kids suffer significant morbidity and, occassionally, mortality. He’s also ripping off parents of autistic kids at his clinic in Austin by encouraging the use of completely unproven treatments. You expect pharma to be held accountable–fine by me. But be consistent, Wakefield must be held accountable as well. You’ll see, when this is over, he’ll lose his right to practice medicine in the UK. Of course, he left there one step in front of the authorities.
patrons99
Does anyone know how to contact Dr Wakefield? He deserves to be notified of this thread. He is being pilloried and his character assassinated by a number of posters. I’d love to hear his defense of these accusations. We can handle the truth. We need to hear his side of the story.
pharmavet
Patrons, assuming hypothetically that Dr. Wakefield came on this site. What would you expect him to say in defense of his record of clinical trial misconduct? Given the unlikelihood of that happening, let’s do some role playing. How would you defend him? My suggestion would be to do a point-by- point reading of the Nuremberg code, for example, and ask him to address each point. If the press is out to destroy his work, which aspects of his work do you think are worthy of preservation in the harsh light of scientific scrutiny? If he is guilty as charged, what should be his “reckoning”, to use your words.
Christopher
There are numerous people who are pilloried and whose characters are assassinated on here but usually they are pharma executives, academics who have worked with pharma, or those who work in businesses that support pharma. But then it’s usually OK it seems.
patrons99
Vet, I would not, could not, and should not presume to speak for Dr Wakefield. A link between ALL vaccines and autism does not live or die based on Wakefield’s work. Despite the media hype, I believe that this issue is far from settled. As for a reckoning, if indeed he is guilty of ethical misconduct, we will all be held accountable to our Maker, or to our consciences (unless we are sociopaths).
Just as an aside, have you ever looked into Andrew Moulden’s work on the internet? Have you not noticed the eye and facial findings of some of the pediatric patients that he has studied before and after vaccination? I am not a neurologist, but I have seen many stroke victims over the years.
patrons99
Christopher, It’s definitely not OK for anyone to be slimed or smeared without the opportunity to speak up on their own behalf. Doesn’t matter whether they are pharma-shills, pharma-independent, or anti-pharma.
patrons99
Sometimes a picture is worth a thousand words! There was a time when I was very naive when it came to vaccinations, and I’ve had more than my share of jabs. Raised in a military family, we were jabbed with great regularity. Then, I started questioning the wisdom of the current stupendous vaccination schedules we are all subjected to. Initially, I entertained the possibility of taking a nuanced approach to risk/benefit as to vaccines, considering each one on an individual basis. But then, in trying to ramp up my knowledge base on the topic of vaccines, I came upon Andrew Moulden’s work. I have since adopted the view that a nuanced approach to vaccine safety is not possible. Please follow this link to see what I mean.
http://911thinktank.org/wp-content/uploads/2009/11/andrew-moulden-slide103.jpg
I’m sure there are those of you who can come up with alternative explanations for the eye and facial findings when comparing before and after vaccination photographs, but I believe you must stretch to explain these findings away. Then I realized how many times in my medical practice I saw brain MRI reports with small lacunar infarcts and nonspecific small vessel ischemic changes. The light bulb went on. Is there cummulative, synergistic toxicity of the metals, adjuvants, preservatives, and uncertain biologic recombinants, found in many of the vaccines administered over a lifetime, which begins in childhood? Is microvascular ischemia and infarction the common mechanism of their toxicity? Moulden’s theories as to vaccine safety warrant serious discussion, consideration, and formal validation. Any theory can be proven wrong. On the other hand, we have a whole lot to lose, by not listening to what he has to say, if his theories are correct. It is not “irresponsible” to want to know.
Christopher
Well patrons I’m not qualified to comment scientifically or medically on your suggestions/questions but please help me with the following: what percentage of vaccinated children do these photos represent? Isn’t is possible that a similar number of reactions - perhaps not so severe - would result from amoxicillin or another ‘benign’ treatment? Or any treatment come to think. It’s pretty easy to find and show exceptions to make a point.
(The photos also look old. I saw these kids on Mad Men.)
You also ask what is the cumulative lifetime effect of exposure to metals, adjuvants etc. How do we know without the ability to isolate other exogenous factors which could feasibly affect outcomes over a period of what - 20 years?
And, as has been asked before, how often in your practice did you have to treat smallpox, diptheria and measles?
patrons99
Christopher:
I don’t want to mislead anyone into thinking that I’m an expert on vaccines or even that I am especially knowledgeable about Dr Moulden’s work. I would certainly welcome Dr Moulden to join our discussion and present his theories to the group. Having said that, my impression is that he views microvascular infarctions, ischemia, and anoxia, as the final common pathway of nearly all disease processes (disease conditions).
I would highly recommend visiting the scribd website where Dr Moulden has posted several copyrighted articles representative of his work.
I do not believe that he accepts Pasteur’s Germ Theory of Disease. “Specific germs do not cause disease…it is the body’s generic immune response that causes disease”. He does reference Virchow’s triad, a concept that I’m sure pharmavet is very familiar. He also references a hemorheologic property called zeta potential, which relates in part to why blood flow does not follow Newtonian fluid dynamics, and explains why aluminum salts, and other highly charged metals, have such a strong pro-coagulant (clot-forming) effect in our bodies.
I recall seeing similar, if not identical, photographs in his scribd articles. As to where he got these photos and whether he has more recent photos, we should ask him.
http://www.intheory.tv/2009/08/video-dr-andrew-moulden-answers-to-autism-and-vaccine-damage/
Moulden claims to have “invented new functional brain imaging protocols”. Functional imaging is near-and-dear to my heart, since Nuclear Medicine was my first board certification, those many years ago. I was once an associate medical director over clinical research and drug safety at DuPont Pharma’s Radiopharmaceutical divison. Nuclear medicine’s strong suit is the ability to image and quantitate organ function and ischemia (with SPECT and PET imaging techniques), whether it be due to large vessel or small vessel disease. Perhaps, tracer studies of radiolabeled vaccine components, targeted at elucidating the biodistributiion and clearance from the body of the various vaccines in an animal model, would shed some light on the question of cummulative toxicity. Alternatively, perhaps EEG or evoked potentials could be studied longitudinally, in before and after vaccination protocols. Regretably, I’m not neurology trained. I am eclectic though.
As to what happened to smallpox, diptheria, and measles, I would refer you to the two articles by Russell Blaylock, M.D., which I’ve already provided links to, earlier in this thread.
It’s difficult to thoroughly address the questions you pose, at a keyboard.
harpy
Pharmavet - by breaking Godwin’s Law, you automatically lose the thread. try again next time
pharmavet
Harpy, you also broke Godwin’s Law, because according to the Law, whenever someone invokes Hitler or one of his supporters, that is supposed to end the thread right there. You broke the rule by continuing the thread. Since that makes us a couple of rule breakers, I claim innocence with respect to the corollary to Godwain’s Law, i.e. Reductio ad Hitlerum. If I had said that Josef Mengele owned a dog, and Andrew Wakefield owned a dog, then Andrew Wakefield would be like Josef Mengele.
JR
I don’t recall scores of Jews picketing outside the Nuremberg trials in SUPPORT of the Nazis like the parents did for Wakefield.
The parents of the children he treated are universal in their support of Dr. Wakefield.
And nothing in the GMC hearings or findings even remotely challenged the truth of his research, there is not even an implication that his findings were not true. Just that maybe he didn’t have the right paperwork in line to do the tests he did. That doesn’t change the results. And his research has helped thousands of kids lead pain-free lives, my twins being two of them.
I’ve met the man and proudly shaken his hand and thanked him for his continued work and recognize the tremendous personal sacrifice he made for the health of children. He could have easily retracted to save himself, but then in what hell would my kids be living in?
patrons99
Did the ethics committee at Royal Free give its conditional approval for Wakefield’s study or did it not? How can anyone hired to do “experimental gastroenterology” perform their job without doing endoscopic and barium studies? Barium studies, endoscopic studies, and lumbar punctures are done all the time, in both hospitals and in specialty clinic settings. How else can radiologists, E.R. physicians, gastroenterologists, neurologists, and infectious disease specialists make diagnoses? Were informed consents properly executed? Do we have access to the GMC panel’s transcript of the proceedings?
pharmavet
I would like to see copies of the informed consents as well. In the United States, even a NON-invasive procedure requires both consent of the child AND assent of the parent after a thorough explanation of the procedural risks. If this was just a “paperwork problem”, it wouldn’t have even been important enough for the GMC or any other regulatory to bother with; a letter and slap on the wrists would have sufficed. Any veteran of clinical research who is intellectually honest will tell you that this was far more serious than not dotting a few i’s or crossing a few t’s.
JR
Here is the complete finding of fact from the GMC, all 143 pages of it:
http://www.rescuepost.com/files/facts-wwsm-280110-final-complete-corrected.pdf
No copies of the informed consent that I could see in there. You will see such statements on most patients about how the procedure wasn’t warranted because there is no record of GI distress in the GP’s records, etc. And quite a few pages of the heinous crime about making a joke about kids at a birthday party getting 5 pounds for a blood draw to use as healthy controls. OH THE HORROR!!!!
Here is where you need a little education in being an autism parent. We all complain about GI problems but he GP (or Pediatrician) never writes it down. They just blow it off as “autism” and say he probably eats a weird diet or is withholding, etc. My kids records won’t show it, but GI pain and diarrhea was our constant battle, our living hell.
But now even the AAP just put out a consesus paper on the importance of looking for GI problems in kids with autism, so maybe this will change and was Wakefield that got the ball rolling, for which he was curcified.
JR
This may end up being a duplicate post but here is the complete report from the GMC, all 143 pages of it:
http://www.rescuepost.com/files/facts-wwsm-280110-final-complete-corrected.pdf
No copies of the consent, but it details the charges. Such horrific crimes as enrolling patient #2 two weeks before the ethic review board signed off on the protocol. Not scoped yet, just enrolled. I’m sorry, but that is a documentation problem. So, yes, a reasonable person would ask, “why is he being so punished for a documentation error?”
Also lots about the GI scopes weren’t warranted because the GP records showed little history of GI distress. Here is where you need an education on being an autism parent. We complain about GI pain and diarrhea every time we see a doctor and they blow it off and don’t write it down. Ask any parent. The answer is always the same, “oh, that’s autism, because they are picky eaters or are with-holding, etc. etc.”
Now even the AAP issued a consensus paper on the importance of looking for GI pain in the ASD population and it is Wakefield that got that ball rolling, to the benefit of tens of thousands of children, and for which he is crucified.
Jan Henderson
The UK’s NHS has a statement on Wakefield and the GMC in Behind the Headlines (http://www.nhs.uk/news/2010/01January/Pages/MMR-vaccine-autism-scare-doctor.aspx). Lots of good links, plus they address questions such as: Why did The Lancet publish the flawed research in the first place?; Is there any evidence that MMR causes autism?; Why did a single flawed study trigger such a huge health scare?; Why has it taken the GMC more than five years to rule on Wakefield’s actions?; and How much damage has the MMR scare done?
Former Pharma Marketing Director
You might want to read what the Cochrane Collaboration had to say about it:
Objectives
We carried out a systematic review to assess the evidence of effectiveness and unintended effects associated with MMR.
Search strategy
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2004, Issue 4), MEDLINE (1966 to December 2004), EMBASE (1974 to December 2004), Biological Abstracts (from 1985 to December 2004), and Science Citation Index (from 1980 to December 2004). Results from reviews, handsearching and from the consultation of manufacturers and authors were also used.
Selection criteria
Eligible studies were comparative prospective or retrospective trials testing the effects of MMR compared to placebo, do-nothing or a combination of measles, mumps and rubella antigens on healthy individuals up to 15 years of age. These studies were carried out or published by 2004.
Data collection and analysis
We identified 139 articles possibly satisfying our inclusion criteria and included 31 in the review.
Main results
MMR was associated with a lower incidence of upper respiratory tract infections, a higher incidence of irritability, and similar incidence of other adverse effects compared to placebo. The vaccine was likely to be associated with benign thrombocytopenic purpura, parotitis, joint and limb complaints, febrile convulsions within two weeks of vaccination and aseptic meningitis (mumps) (Urabe strain-containing MMR). Exposure to MMR was unlikely to be associated with Crohn’s disease, ulcerative colitis, autism or aseptic meningitis (mumps) (Jeryl-Lynn strain-containing MMR). We could not identify studies assessing the effectiveness of MMR that fulfilled our inclusion criteria even though the impact of mass immunisation on the elimination of the diseases has been largely demonstrated.
Authors’ conclusions
The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate. The evidence of adverse events following immunisation with MMR cannot be separated from its role in preventing the target diseases.
The design and reporting…..are largely inadequate….
They only draw their conclusions based on the worldwide decrease in incidence since vaccination programs. Does anyone actually look at the increase in diagnosis versus vaccines?
I am not sure what side of the argument I am on, - to vaccinate or not to vaccinate. I didn’t bother with the H1N1 shot this year, and I am done with flu shots. Last year I had Hep vaccines updated, so I am not completely against vaccines.
I am concerned about batching them all together and giving them all in one big shot. Logically this doesn’t make sense. I think we also have to look at what changes there are in making the vaccines.
As for Dr. Wakefield, in research we all have to dot our i’s and cross our t’s….That being said, I feel his frustration and the frustration of all patients. Who will fund the appropriate studies? I can’t imagine Pharma stepping up to do this and the data has been so spun out of control now it will be hard to get a credible independent organization to put up the money.
A great travesty and I deeply regret this and feel the frustration of parents coping with autistic children…
I hope more people boycott vaccines only to make the issue more urgent and make it become an important problem to be addressed - fairly and squarely….
Reality Check
Former,
How disingenuous can you be? The written summary from the Cochrane report that you reference concludes, “No credible evidence of an involvement of MMR with either autism or Crohn’s disease was found.” So much for Wakefield’s studies. In addition, it is next to impossible to do a field trial testing the effectiveness of an accepted vaccine since no respectable IRB would ever approve such a study. The report acknowledges that “Measles, mumps and rubella are three very dangerous infectious diseases…” and concludes (as you mention) “…the impact of mass immunisation on the elimination of the diseases has been demonstrated worldwide.”
Clearly the reason why the GMC doesn’t need to rule on Wakefield’s unethical science is that it has been clearly refuted already.
Reality
pharmavet
Speaking from the vantage point of someone who has actually done studies in pediatric gastroenterology, the overwhelming majority of pediatric dysmotility disorders in normal and autistic children are functional in nature, do not require endoscopic verification and can be managed by biopsychosocial support. I have interviewed leading experts in the area of functional GI motility disorders in children, and can state categorically that the overwhelming majority of these kids do not need to be scoped. If anyone professes otherwise, please state your professional credentials in responding.
Former Pharma Marketing Director
Reality,
How disengenouds can I be? I didn’t write the Cochrane report….This report was reference by the the UK NHS….
I think Dr. Wakefield should have been more ethical…
Christopher
From BBC News: Lancet has issued a full retraction of the MMR study in question. I believe this is a new development:
http://tinyurl.com/ycy38ss
pharmavet
Confirmed on CNBC. Case closed. Time to button this one up, Ed.
http://www.cnbc.com/id/35197885
Condor
True enough, Christopher and ‘Vet.
Now, to be fair, here is Wakefield’s statement about The Lancet retraction decision, mentioned above:
. . .”The allegations against me and against my colleagues are both unfounded and unfair. We invite anyone to review the record, and to draw their own conclusions,” Wakefield said in a statement. . . .
In a related development, Merck’s NYSE stock price is rising modestly on the news.
Namaste
patrons99
The Lancet has simply decided to cut it losses in the court of public opinion. The clinical question Wakefield sought to answer was, and still is, an important one. The ethics board is not beyond reproach on this one. Further, the GMC has not rendered its final rulings.
In seeking to answer the question as to whether the GI symptoms of MMR vaccinated/autistic kids is functional or organic, you have to perform invasive testing. “Biopsychosocial support” doesn’t answer the clinical question. Perhaps, a better study could be designed.
As to the larger question of a possible link between any vaccine and autism, the answer does not live or die based on Wakefield’s work. There may be other ways to address the question.
I have a brother with congenital rubella syndrome. I take this topic personally.
pharmavet
Since you brought up congenital rubella, it is known that even with the best vaccines immunity can fade over time, so that a pregnant woman whose vaccine immunity has faded can still transmit the virus if she is infected during the first trimester of pregnancy. I’m sorry for your brother, but scientifically it simply does not compute that this is necessarily the fault of the vaccine in the absence of a medical history here.
Former Pharma Marketing Director
Agreed Patrons, besides, why should we care about what a medical journal says anyway? We, as in the pharma industry have done a lovely job of corrupting them. Does it matter to me that they have retracted - not in the least…
Problem is that we have skewed the system so much that “anything” goes…..
Just say “No” to vaccines….And we should just say No to a lot of other things. Patients are better off doing what they want, otherwise they are just doing what the marketing department of pharma thinks they should so….
There is no medicine or science left
pharmavet
Patrons I should also state, using your terms “cutting its losses”, when a journal has to issue a retraction, it’s pretty embarrassing, so the best way to “cut its losses” without attracting attention and not lose circulation is to bury the retraction in a future issue. It would be in the Lancet’s worst interest economically speaking to issue such a public retraction. No, this very public retraction was done in the name of scientific and journalistic integrity, not to “cut its losses”. I’ve been onn the editorial board of several journals, and I know first hand how the retraction process works.
Christopher
FPMD - if journals have been corrupted to the point you suggest, and so nothing that appears in them can be trusted, what should we trust for sources of honest, clean data? I agree that some journals have been used as vehicles for pharma interests, but everyone knew which they were anyway and took them as such. Lancet and many others were nothing of the sort and operated appropriately.
I’m not arguing this specifically in relation to the Dr Wakefield case, but because you the point you raise is, in my opinion, overstated and misleading. What are we to believe then? There are many links on here to blogs, meta-analyses by special interest groups, reviews and so on that have never passed scrutiny by peer review. Unfortunately some will read these and believe them.
I think I see where you are going with this but believe you do a disservice to legitimate scientific publications with your comments.
Jan Henderson
Christopher – I took FPMD’s post to be tongue-in-cheek.
What about the suggestion by Spielmans and Parry in their article under discussion in a recent Pharmalot post (“The Rise Of Marketing-Based Medicine”): “A former editor of BMJ, Richard Smith, suggests that journals should cease the publication of clinical trials. Rather, trial protocols and results could be published in some form of online registry. Journal articles would then discuss the validity of these trials. This may seem like an odd solution, but there is in fact little evidence that peer review is linked with notably better reporting of trial results.”
pharmavet
Jan, it’s a simple matter of economics. Drug ads are the major source of revenue for journals. If journals stopped publishing clinical trials their ad revenue would dry up. They would have to significantly raise subscription costs, which are astronomical anyway or be faced with extinction. To put in perspective, in 2009 I went back to the medical school library where I used to study, looking for a recent article. I noticed that the most recent journals were no later than 2006. Upon questioning the librarian I was told that the high cost of journal subscriptions precludced the library from renewing their subscriptions for three years running. My only other option was to order the article online for $25; to me it was an Hobson’s choice.
Christopher
Jan - fair point. I assumed that FPMD’s comments were broadly consistent with the tone of previous ones, but I missed the tongue-in-cheekiness, I’m sorry.
pharmavet rightly comments that journal publishing is about economics. It’s a business that must be sustained, and deliver profits, primarily thorugh subscription and advertising. The latter, as is obvious, flows from parties whose interests are covered by content in the journal. Subscriptions are down partly due to free or selectively paid for access via internet. So journals’ business model is brittle.
I would imagine that restricting journals’ involvement in clinical trial reporting would be limiting because the impact of publication, discussion, and follow up correspondence would be dliuted if comment followed only after publication on a third party site. Advertising would decline too.
Whether the peer review process results in ‘better’ reporting of clinical trial results is open to discussion: all I want is to know that professional consideration of content and its associated conclusions has taken place before publication. Perhaps in some way that review provides a filter that would not prevail if studies and results were published on a third party site - as you describe - where those results were open to egregious manipulation and interpretation by those so motivated.
I think also that medical publishing, like every other sort, is undergoing massive change and that charging for content will have major repercussions on how journals and the like are accessed in the future.
Former Pharma Marketing Director
They were tongue in cheek comments.
Christopher, you are an annoying self serving idiot…
You Jan and Pharmavet probably all sit next to each other in your cubicles and pretend to play medicine….
Christopher
FPMD - whatever you say. So, I’m an idiot and you are a savant, but you didn’t answer my question did you?
Windbag…
Lisa Van Syckel
Pharmavet,.. you are a wee bit misguided, it is the “assent” of the child,.. and “consent” of the parent.
pharmavet
Sorry, Lisa, I had it backward. Point is the same. You need the double approval.
pharmavet
Dear FPMD:
Just for the record, I don’t work in a cubicle anymore. I work in a fairly spartan office furnished by Ikea, not the lavish mahogany-paneled offices that some seem to think that all Pharma folks work out of.
Lisa Van Syckel
Pharmavet,. in the real world, double approval doesnt exist. Children are incapable of giving informed consent, except, when consenting to an abortion, a little different then consenting to meds, or receiving a teen screen test in school.
pharmavet
I’m all for greater empowerment of children in the consent process. In fact, older adolescents are pretty much capable of giving consent on their own. I think that it’s silly to make these subjects get parental consent when in some states they are old enough to drive a car or even marry.
John
Many of the scientific (non-medical) journals that I subscribe to carry no advertising and cost less than $200 per year for a subscription.
I agree that it would be better if medical journals did not accept ads. But claiming that the pharma companies own the journals lock stock and barrel because $300K/year physicians don’t want to pay $200 for a subscription seems like a bit of a stretch.
pharmavet
I find about 6-7 papers that are important to me out of 52 issues of NEJM each year. I don’t plan to pay $200 for the priviledge.
patrons99
Before we all hold a Requiem for Dr Wakefield, we should perhaps heed his call for us to “review the record”. There is clearly much more to this story than meets the eye.
See the article titled “Secret British MMR Vaccine Files Forced Open By Legal Action”, posted on January 13, 2009 by childhealthsafety, where it states,
“The CEO of the owners of Richard Horton’s “The Lancet”, Crispin Davis, was appointed to the MMR litigation Defendants’ parent company GlaxoSmithKline’s board of directors in July 2003.”
http://www.whale.to/vaccine/mmr666.html
http://www.whale.to/b/horton_h.html
http://www.whale.to/vaccines/davis_h.html
http://childhealthsafety.wordpress.com/2009/01/13/secret-british-mmr-vaccine-files-forced-open-by-legal-action/#US_Developments
Moulden Is A Quack
At least Wakefield does not advocate not giving vaccines to any child. There are other complete nutcases like “Dr” Andrew Moulden who claim nobody should ever be vaccinated. Are you kidding me? Nobody? This guy says vaccines cause AIDS, cancer and SIDS through strokes and takes pictures of people to prove it. Look at his site, if you need a laugh. He thinks JFK was killed by vaccines apparently. I guess Lee Harvey Oswald put a syringe in his rifle in 1963. If Moulden was in charge, no child would be vaccinated. Moulden’s world would be filled with crippled children suffering from polio, and dead youngsters with measles, mumps and rubella. Sometimes, you have to think about what you say and write. Cure AIDS and cancer by eliminating vaccines? Really? Open your eyee people. Someone like Wakefield may be a hero, but he may simply hurt people and has no place in this debate.
patrons99
I will not respond to anyone’s ad hominem attack. I do not speak for Wakefield or Moulden. They can defend their views themselves. For some time now, I have been trying ramp up my knowledge as to vaccine safety and efficacy as, I hope, everyone else is too.
Here are some links that bear directly on this topic:
A letter titled _Les Incompetants: Open Letter to the AAP_ by K. Paul Stoller, M.D. on 02/26/2008, can be found at this link:
http://www.whale.to/a/stoller.html
K Paul Stoller, MD, FACHM, on January 13th, 2009 at 3:42 pm Said:
The truth that vaccine policy is not about science or safety but about money and politics is finally seeing the light of day.
We have a choice to make about not only holding responsible parties accountable for destroying the lives of untold children around the world, but whether we want to destroy the human genome by the continued injection of dirty vaccine that punches holes in our immune systems.
The history of vaccine in littered with horrible mistakes and skulduggery – from the SV40 virus given to millions in the polio vaccine to the continued use of mercury and other heavy metals. The fact is even the best MMR vaccine is contaminated with avian retro virus and reverse transcriptase. This is criminal!
Jennifer Craig, Ph.D, on January 16th, 2009 at 8:19 am Said:
Having read the history of all vaccines, this does not surprise me at all. The first smallpox vaccine was never shown to decrease smallpox incidence or deaths and hundreds of people were injured by the vaccine. Yet this nonsense has gone on now for over 150 years. When are people going to realise that injecting a toxic brew straight into a child’s bloodstream is voodoo medicine. The wonder is that so many children survive.
Sunday Times Journalist Challenged Over Role in US MMR Cases & Denying Being Complainant In UK MMR Case « Child Health Safety, on February 16th, 2009 at 11:43 am Said:
[...] In the UK Brian Deer’s first attacks in The Sunday Times on Wakefield [Sun 22/Feb/04] was also made just days before a crucial Court decision [Fri 27/Feb/04] which took away legal funding from the British MMR vaccine damage children’s case. The Judge who took the money away, Judge Nigel Davis, is the brother of Glaxo board director Crispin Davis who had been hired onto the Glaxo Board only 2 months before The Sunday Times hired Deer to trash Wakefield. Crispin Davis was conveniently for Glaxo, the CEO of the owners of The Lancet. Judge Davis later claimed that it had not occurred to him there might be a conflict of interest. Read more about it all here: British Government & Establishment’s Efforts to Deny Compensation to MMR Vaccine Child Victims. [...]
Jennifer Craig, Ph.D, on March 11th, 2009 at 6:47 pm Said:
Most people assume that a vaccine is composed of selected viruses in a sterile fluid to which preservatives have been added. Not so.
Vaccines are suspensions derived from the manufacturere’s ‘incubation tanks’ in which the viruses are produced from substrates of mashed bird embryo, minced monkey kidneys or cloned human cells. These suspensions are filtered before use but only to remove particles larger than viruses. The point of the vaccine is that it contains viruses, so these must not be filtered out. Therefore, anything smaller than a virus remains.
These remains include what the manufacturers call ‘degradation products’ – parts of decayed viruses or cells, unknown bits and pieces, foreign protein particles, viral oncogenes (might cause cancer), added chemicals and DNA fragments.
How to remove contaminating DNA has caused some concern to the Authorities, which is comforting. In 1986, the US government recommended a weight limit of 100 picograms of contaminating DNA per vaccine dose. However, this has proved so impossible a standard to achieve that they now allow one hundred times that amount, i.e. 10 nanograms per vaccine dose.
In other words, the vaccines we inject into our children are liquids filled with unknown particles, most of which come from cells of non-humans: from chickens, monkeys, and even from cancer cells. Plus the DNA of other species. No wonder so many of them are chronically sick.
john
This is what the WHO has to say about it.
http://www.who.int/immunization_safety/aefi/immunization_misconceptions/en/index.html
The overwhelming consensus of tens of thousands of people who study a subject for a living is not always correct. But betting against it has poor odds.
http://www.alaska.net/~clund/e_djublonskopf/Flatearthsociety.htm
annonyed
John, Pharmavet and others opposed to thoroughly questioning the vaccine situation, here is some advice.
Please go eat Sh*t - because with your logic 10,000,000,000 FLIES cannot be all wrong!!!!!
Patrons 99 is telling you and all of us to put aside our pay checks and “self-Interest” and scrutinize the situation…
You call yourselves scientist, doctors? Give us all a bloody break, you are suits from wall street dressed up in lab coats…
patrons99
O.K. John, I will read your links. Thanks.
Here are two links that you might wish to look at. They both bear relevance to this very important topic:
http://www.ageofautism.com/2010/02/a-statement-from-jenny-mccarthy-jim-carrey-andrew-wakefield-scientific-censorship-and-fourteen-monke.html
http://fourteenstudies.org/pdf/primates_hep_b.pdf
john
Annoyed, I will be happy to debate this issue with you provided we agree to discuss data and its interpretation. Telling someone to eat Sh*t is not a rebuttal. Its just a sign that someone has challenged your beliefs, and you are not willing to engage in a discussion that might force you to reappraise your beliefs.
Patrons99, I will take a look at your links. I don’t really have a problem with throughly investigating any issue. The overwhelming majority of the scientific community is wrong sometimes, I just don’t think the general public recognizes how uncommon it is or how strong the pro-vaccine consensus is among those who worry about these things for a living. Vaccine safety is really not one of the hot topics of debate in the biomedical community, the debate is all about how to quell people’s fears and get their kids vaccinated.
I will add that I’m not really a big fan of mercury, and am pleased that it is being phased out. I know that at least one study has concluded that it is not a problem, but it just seems like a bad idea.
patrons99
John, vaccine safety should be at the very center of the debate, for all of the reasons already mentioned in this thread and related threads. I share your concern as to mercury. What about the aluminum salts and their effect on zeta potential of blood? What about the risk of uncertain biologic recombinants?
http://www.pharmalot.com/2010/01/was-swine-flu-a-false-pandemic/
http://www.pharmalot.com/2010/01/anti-vaccine-activist-sues-vaccine-advocate/
John
Patrons, clearly safety (or as I am so fond of repeating, risk/benefit ratio) is the core issue for any medical technology. I think the mainstream scientific community has concluded that this issue has been settled, and moved on. Not having a lot of detailed knowledge of the subject, I am just working off the observation that the scientific mainstream is usually on the mark, though there are certainly exceptions.
With apologies for posting another link before I have had time to look at yours, I found this one interesting. No doubt you are familiar with the data and have a different interpretation than my own, but what the hell….
http://www.visionofbritain.org.uk/data_cube_page.jsp;jsessionid=8E8035838DAFE60ACE22AF8FD3C8E1E5?data_theme=T_VITAL&data_cube=N_CoD_QR_SUBD&u_id=10001043&c_id=&add=Y
annonyed
John,
Your beliefs are being challenged. Mine are not…
You are the one who doesn’t like it.
Let us know when you have read the links Patrons sent you…
Jan Henderson
A thoughtful Salon article by Dr. Rahul K. Parikh. “Public distrust” refers to the MMR news following closely on the handling of mad cow disease in the UK:
As a pediatrician, I grapple daily with what Wakefield wrought: parents who are twisted in knots — to the point of tears — about whether to immunize their child.
The Lancet, one of the world’s most well-known medical publications, played an enormous role here, showing us how medical journals are at risk for their own kinds of malpractice. Offit’s “False Prophets” details how Richard Horton, then the journal’s editor in chief, seemed enamored of the notion of publishing something muckraking. As Offit writes, “By ignoring the criticisms of several reviewers, the warnings of an accompanying editorial, Wakefield’s history of holding press conferences, a British press primed for controversy, and a public distrustful of pubic health officials, Richard Horton allowed the public to question the safety of a vaccine based on flimsy, irreproducible data. The loss of the public trust that followed was entirely predictable.”
Jan Henderson
I forgot the link: http://www.salon.com/mwt/feature/2010/02/04/autism_debunked/index.html?source=newsletter
SKFinston
As the mother of a child on the autism spectrum who received MMR, etc., in the early to mid-1990’s I have watched this circus unfold from just about the time of our initial diagnosis.
Now we know the following: Dr. Wakefield had an undisclosed financial interest in both a competing product (single dose vaccine in place of MMR) and as a paid consultant to a lawyer seeking support for a related medical malpractice case. This is outrageous and unethical, and is not in dispute.
The original study itself was tiny and I thought always overblown in terms of the attention it received for questionable data. More generally, I also have read a lot about possible causes of autism, genetic, medical, etc., and have never seen convincing data, or even correlation, between vaccinations and autism trends. (It is like the recent study in California that found that the level of education of the parents is the single biggest determinant of whether a child receives an autism diagnosis.)
And in our case, we have tried GF, Dairy Free, Auditory Training, Cod Liver Oil, Epsom Salt Baths, Secretin clinical research and more . . . so before the attacks come, we are not captives of “Big Pharma” . . . . Sorry, but the data is just not there (for those who care about empirical data).
My suggestion: Let’s focus on getting our kids better support and stop kicking this dead horse.
Sometimes bad things happen and it is not possible to know why. This used to keep me awake nights.
Now I am much more concerned about what happens when all of our kids reach the age of 18+ and are no longer in school or on our insurance. I have seen no obvious game plan at the national, state or local level and this is a disaster in the making.
patrons99
In an article on February 11, 2010, titled “Mumps outbreak spreads among people who got vaccinated against mumps”, Mike Adams makes some very interesting points.
http://www.naturalnews.com/z028142_mumps_vaccines.html
http://edition.cnn.com/2010/HEALTH/02/08/mumps.outbreak.northeast/index.html?hpt=T2
“Just this week, an outbreak of mumps among more than 1,000 people in New Jersey and New York has raised alarm among infectious disease authorities. The outbreak itself is not unusual, though. What’s unusual is that the health authorities slipped up and admitted that most of the people infected with mumps had already been vaccinated against mumps.”
Andrew
In Canada (I suppose also globally) no one can trust medical establishment controlled by PHARMACEUTICAL INDUSTRY.
Citizens become a resource of immense profits. People inflicted by medical conditions are in DEMAND.
More sick/ suffering people = more business/ profits.
OUT of one medical disorder Industry generates many more disorders and unnecessary medical proceedings!
General Public is being exploited, abused, subjected to horrifying suffer and sacrificed by Pharmaceutical industry. MEDICAL ESTABILISHMENT IS CONTROLLING GOVERNAMENT AGENCIES AND SOME /MANY POLITICIANS.
Nancy
From the Austin American Statesman:
“British doctor resigns as head of Austin autism center”
http://tinyurl.com/ykc8nlw
Ross Coe
As a father of a vaccine damaged son, I believe Andrew Wakefield is the victim of “WHISTLE-BLOWER SYNDROME” He threatened, albeit indirectly, the reputation, product, and profits of a powerful industry, with close ties to government and medical realms in the UK. He was dragged in front of a kangaroo court, convicted via a predetermined judgement, meant to castrate him professionally, and to send a message to all whistle blowers that you had better not mess with the status qou, or the billions of dollars this industry receives for their products. Its not about vaccine safety, its not about truth, its about revenge, its about profit, its about power, its about corruption.