I am constantly amazed at the low level of proof people use to demonstrate that vaccines cause autism.
Case in point, David Kirby and his recent post on the Age of Autism blog (and, a I write this, The Huffington Post).
He takes an abstract from a poster session and declares victory in the war to prove vaccines cause autism.
Here’s the abstract:
HEPATITIS B VACCINATION OF MALE NEONATES
AND AUTISM
CM Gallagher, MS Goodman, Graduate Program in Public
Health, Stony Brook University Medical Center, Stony Brook, NY
PURPOSE: Universal newborn immunization with hepatitis
B vaccine was recommended in 1991; however, safety
findings are mixed. The Vaccine Safety Datalink Workgroup
reported no association between hepatitis B vaccination
at birth and febrile episodes or neurological adverse
events. Other studies found positive associations between
hepatitis B vaccination and ear infection, pharyngitis, and
chronic arthritis; as well as receipt of early intervention/
special education services (EIS); in probability samples of
U.S. children. Children with autistic spectrum disorder
(ASD) comprise a growing caseload for EIS. We evaluated
the association between hepatitis B vaccination of male
neonates and parental report of ASD.
METHODS: This cross-sectional study used U.S. probability
samples obtained from National Health Interview Survey
1997–2002 datasets. Logistic regression modeling was used to
estimate the effect of neonatal hepatitis B vaccination on
ASDrisk amongboys age 3–17 years with shot records, adjusted
for race, maternal education, and two-parent household.
RESULTS:Boyswho received the hepatitis B vaccine during
the first month of life had 2.94 greater odds for ASD (nZ31
of 7,486; OR Z 2.94; p Z 0.03; 95% CI Z 1.10, 7.90)
compared to later- or unvaccinated boys.Non-Hispanicwhite
boys were 61%less likely to haveASD(ORZ0.39; pZ0.04;
95% CIZ0.16, 0.94) relative to non-white boys.
CONCLUSION: Findings suggest that U.S. male neonates
vaccinated with hepatitis B vaccine had a 3-fold greater risk
of ASD; risk was greatest for non-white boys.
What did they do? They looked at data from the National Health Interview Studies, and looked at autism and hepatitis B vaccination. They used surveys from 1997 to 2002, with children aged from 3 to 17.
Mr. Kirby was kind enough to post an image of the poster to the EOHarm group.
The autism group had 33 kids total. Of these, 9 of 31 (29%) were given the HepB vaccine. Compare this to 1,258 of 7,455 (17%) of the non-autism group who were given the HepB.
9 out of 31.
Are the red flags up yet? They should be.
Take for example kids aged 17 in the 1997 survey. When were they born? That’s right, 1980.
When was the Hepatitis B vaccine introduced? 1991. According to Mr. Kirby himself, the HepB vaccine didn’t get fully implemented until about 1996.
A lot of the kids were born before the “epidemic” of autism. No one disputes that the number of people identified with autism has gone up significantly in the last 30 years.
So, pretty much anything that changed in that time would “correlate” with autism.
This is how we get studies that “show” that Cable TV causes autism. And, now, the Hepatitis B vaccine causes autism.
How should a pediatrician tell you your child may have a disability?
That’s a big question. This is one that comes up a lot in the autism world. Many people say, “my doctor told me that my kid would never be able to talk, walk or take care of him/herself but he/she made big gains” Others complain that diagnosis of disability was missed, delayed or downplayed.
The AAP has issued guidelines on screening for autism, for example. But what is the correct balance of how to warn a parent that his/her child may have autism or another disability?
OBJECTIVES: The goals were to investigate parents’ and early intervention (EI) specialists’ beliefs and experiences regarding discussing child development in primary care and to identify communication barriers and opportunities.
METHODS: Focus groups were held with (1) mothers of young children with typical development, (2) mothers of young children who received EI services, and (3) EI specialists. Seven groups (N=46 participants) were conducted in the greater Cleveland, Ohio, area. Meetings were audio-recorded, transcribed, coded, and analyzed, to identify themes.
RESULTS: Most mothers reported a preference for a nonalarmist style of communication when developmental delays are suspected. In contrast, some mothers preferred amore direct style, including the use of labels to help them understand their child’s development. The importance of preparation to accept information about developmental delays emerged as a theme in all groups. Elements contributing to preparedness included information about expected developmental skills, suggestions for promoting skills, and a specific time frame for follow-up evaluation. Mothers of children with disabilities perceived that early reassurance of normalcy by providers in response to their concerns led to self-doubt and increased difficulty accepting the diagnosis.
CONCLUSIONS: Mothers and EI specialists have clear ideas about factors that promote or impede communication regarding child development. This information can inform primary care providers’ approaches to monitoring and screening the development of young children and to communicating with parents regarding suspected developmental delays. Pediatrics 2009;124:e705–e713
The researchers worked with focus groups of parents of children who were in early intervention, parents of children who were not in early intervention and early intervention professionals.
Separate focus groups were held with 3 types of participants, that is, (1) mothers of children who were receiving/had received EI services (EI parents), (2) mothers of children <5 years of age who had not received EI services (non–EI parents), and (3) EI specialists.
The groups were small (the total number of participants in all groups was 46).
The study found that most parents don’t express concerns directly. Rather than say, “Is my child delayed?” a parent is more apt to say, “Should my child be talking by now?”.
It is important that providers recognize that parental expressions of concern may be stated subtly, indirectly, or briefly. A related theme that emerged was the perception of not being heard. Previous studies indicated that providers’ failure to acknowledge or to address patient concerns is unfortunately widespread.
That isn’t going to be a shocker to any parent reading this–some parents feel like their pediatricians aren’t listening.
But, how should a doctor approach the issue of possible developmental delays? Unfortunately, there isn’t a clear answer. Some parents say go slow and gentle, others say be direct.
Parental preferences for direct (straight talk) versus indirect (sugarcoating) communication approaches seemed to be related to preparation to hear about suspected delays. Some
parents needed weeks to months to prepare to hear such news, beyond the brief “warning shot/forecasting” recommended for medical encounters
The sugar-coater parents recommended:
Nonalarmist wording by providers, maintaining optimism and acknowledging that the child’s development might not be delayed, was recommended. Parents also recommended providing information regarding what to observe, possible next steps for further evaluation, and a plan to check in with the provider within a short time
I am not a sugar-coater. But, I like the idea of giving information of what to observe. I don’t really see the value in just saying, “Let’s wait and see”. Let’s wait and see what, exactly? Give parents some homework, things to watch for.
The “straight talkers” recommended a more direct approach:
Other parents cautioned against sugarcoating and favored a direct approach, emphasizing the importance of straight talk. By inquiring systematically about parents’ developmental concerns, providers can obtain information regarding parents’ readiness to hear about suspected developmental delays and can tailor communication to the level of preparation.
I’d probably go even beyond the “straight talkers”. I’d say it’s better to hear the possible situation as soon as the doctor has suspicions rather than to wait for the parent to be prepared.
What’s the value to “let’s wait and see”? Is there any downside to early intervention besides the logistics of getting a kid here and there for therapies and the worry about possible delays? I don’t think so. OK, there is the financial cost to an already overloaded system. But in general, what’s wrong with saying, “Well, junior is now 3 and the speech and occupational therapy is no longer needed”? Compare that to, “Well, Junior is about to turn 3 and, yep, we should have gotten him started in early intervention last year”.
In other words, since doctors are going to make mistakes in their suspicions they should err on the side of possibly “alarming” a parent.
One problem doctors face is that parents are not always going to give the doctors accurate information:
Negative communication experiences included parents’ feeling blamed by providers for the child’s developmental delay. In 1 group, mothers reported that they might respond in the affirmative to questions regarding developmental milestones even when their child was not yet demonstrating a skill, out of concern that lack of attainment would be seen as evidence of neglect.
Doctors are definitely faced with a dilemma. There is no one approach that will fit what all parents want. Some don’t want to be alarmed. Some want to know all suspicions right away. Some are not going to express their fears or questions. Doctors are going to make “mistakes”.
Again, I am more in favor of a “straight talker” as my kid’s pediatrician. Yes, I am a consumer when I go to the doctor. But what I am paying for is to be told what I need to hear, not what I want to hear. It isn’t whether I am prepared to hear that my child may be delayed, but whether my child may need to start therapy. I can get over the shock. Even if I can’t, my kid counts more.
Dr. Andrew Wakefield, not of Thoughtful House in the U.S., has recently been called before the General Medical Council for a “fitness to practice hearing”. The allegations stem from activities related to his research of about 10 years ago on children (many autistic).
I recently discussed two of incidents being investigated: a birthday party where blood was drawn from typically developing children (for controls) and activities related to his invention and the subsequent patent his hospital (the Royal Free) applied for. I found it interesting to see these layed out, so I decided to post them here for others to read as well.
These are allegations. The process has not concluded, nor has any decision been reached.
This is a short version. A detailed list (93 pages) can be found on Brian Deer’s website. Note that these 93 pages include allegations against Doctors Murch and Walker-Smith.
Dr Andrew WAKEFIELD GMC Reference number: 2733564
Professor John WALKER-SMITH GMC Reference number: 1700583
Professor Simon MURCH GMC Reference number: 2540201
The GMC’s statutory purpose is to protect, promote and maintain the health and safety of the public by ensuring proper standards in the practice of medicine.
We investigate complaints about individual doctors in order to establish whether their fitness to practise is impaired and whether to remove or restrict a doctor’s registration.
The GMC does not regard its remit as extending to arbitrating between competing scientific theories generated in the course of medical research.
The following is a summary only of the allegations which will be made before the Panel at the forthcoming hearing.
The Panel will inquire into allegations of serious professional misconduct by Dr Wakefield, Professor Walker-Smith and Professor Murch, in relation to the conduct of a research study involving young children from 1996-98.
Dr Wakefield, Professor Walker-Smith and Professor Murch, were at the relevant times employed by the Royal Free Hospital School of Medicine with Honorary Clinical contracts at the Royal Free Hospital.
It is alleged that the three practitioners were named as Responsible Consultants on an application made to the Ethical Practices Committee of the Royal Free Hospital NHS Trust (“the ethics committee”) in 1996 to undertake a research study involving children who suffered from gastrointestinal symptoms and a rare behavioural condition called disintegrative disorder. The title of the study was “A new paediatric syndrome: enteritis and disintegrative disorder following measles/rubella vaccination”. The Panel will inquire into allegations that the three practitioners undertook research during the period 1996-98 without proper ethical approval, failed to conduct the research in accordance with the application submitted to the ethics committee, and failed to treat the children admitted into the study in accordance with the terms of the approval given by the ethics committee. For example, it will be alleged that some of the children did not qualify for the study on the basis of their behavioural symptoms.
It is further alleged that the three practitioners permitted a programme of investigations to be carried out on a number of children as part of the research study, some of which were not clinically indicated when the Ethics Committee had been assured that they were all clinically indicated. These investigations included colonoscopies and lumbar punctures. It is alleged that the performance of these investigations was contrary to the clinical interests of the children.
The research undertaken by the three practitioners was subsequently written up in a paper published in the Lancet in February 1998 entitled “Ileal-Lymphoid-Nodular Hyperplasia, Non-Specific Colitis and Pervasive Developmental Disorder in Children” (“the Lancet paper”).
It is alleged that the three practitioners inaccurately stated in the Lancet paper that the investigations reported in it were approved by the ethics committee.
The Panel will inquire into allegations that Dr Wakefield and Professor Walker-Smith acted dishonestly and irresponsibly in failing to disclose in the Lancet paper the method by which they recruited patients for inclusion in the research which resulted in a misleading description of the patient population in the Lancet paper. It is further alleged that Dr Wakefield gave a dishonest description of the patient population to the Medical Research Council.
The Panel will inquire into allegations that Dr Wakefield and Professor Walker-Smith administered a purportedly therapeutic substance to a child for experimental reasons prior to obtaining information about the safety of the substance. It is alleged that such actions were irresponsible and contrary to the clinical interests of the child.
The Panel will inquire into allegations that Dr Wakefield was involved in advising solicitors acting for persons alleged to have suffered harm by the administration of the MMR vaccine. It is alleged that Dr Wakefield’s conduct in relation to research funds obtained from the Legal Aid Board (“LAB”) was dishonest and misleading. It will be alleged that Dr Wakefield ought to have disclosed his funding from the LAB to the Ethics Committee but did not.
The Panel will inquire into allegations that Dr Wakefield ordered investigations on some children as part of the research carried out at the Royal Free Hospital from 1996-98 without the requisite paediatric qualifications to do so and in contravention of his Honorary Consultant appointment.
The Panel will inquire into allegations that Dr Wakefield failed to disclose his involvement in the MMR litigation, his receipt of funding from the LAB and his involvement in a Patent relating to a new vaccine to the Editor of the Lancet which was contrary to his duties as a senior author of the Lancet paper.
The Panel will inquire into allegations that Dr Wakefield acted unethically and abused his position of trust as a medical practitioner by taking blood from children at a birthday party to use for research purposes without ethics committee approval, in an inappropriate social setting, and whilst offering financial inducement.
We cannot guarantee that all those wishing to attend the hearing will be able to do so, as seating is limited. If you plan to attend the hearing please email the GMC press office press@gmc-uk.org. In the event that we have to allocate seats those people who have notified the press office will be seated before others.
-Ends-
Greater detail can be found in this document, hosted on Brian Deer’s website. It is 93 pages of details of the allegations against Dr. Wakefield, Dr. Walker-Smith and Dr. Murch.
As a bit of background: before Dr. Wakefield’s 1998 Lancet article was published, his hospital, the Royal Free, had submitted a patent application for an invention of Dr. Wakefield’s. The application was titled, “PHARMACEUTICAL COMPOSITION FOR TREATMENT OF IBD AND RBD”
IBD is “inflammatory bowel disease”
RBD is “regressive behavioural disease” “(also referred to as pervasive developmental disorder)”
(definitions taken from Dr. Wakefield’s Great Britain patent application 2,325,856)
As you might assume from the title, the patent has as a main thrust the idea that certain transfer factors could be used therapeutically. In other words, the main point appears to be to use this as a treatment. This does not exclude the fact that the patent also includes a claim for a classic, preventive vaccine.
The original patent application, filed June 6 1997 (before Dr. Wakefield’s first autism paper in The Lancet), is shown on Brian Deer’s website.
There are nine claims to the patent. Eight of which relate to the proposed treatment. Claim two, however, states:
The composition according to claim 1 adapted for use as a vaccine for the prophylaxis of measles virus.
The existence of such a patent application raises the obvious question of conflict of interest. In other words, was there the possibility that Dr. Wakefield’s invention could result in royalty payments to Dr. Wakefield for a vaccine? Could he profit from what amounts to a single vaccine for measles (as opposed to the combination virus MMR vaccine)?
Dr. Wakefield in a previous statement (again hosted on Brian Deer’s website):
The reference to the possible use of TF [transfer factor] to protect children against measles infection – the thrust of the Sunday Times’ conspiracy theory – was put in as an afterthought in the patent. It was entirely speculative and never pursued in any shape, manner or form.
The provisional patent filing was entirely speculative and was for a possible therapy; as such, it had no bearing on the 1998 Lancet paper.
Note that Dr. Wakefield acknowledges that his invention was claimed to be able to protect against measles infection. As we will see below, this is in direct contrast to his statements on Dateline.
Before we delve into that, I must strongly disagree with Dr. Wakefield as to whether this had bearing on the 1998 Lancet article. Part of the patent application clearly claims the use of the invention as a vaccine. Whether the invention was speculative or that the main use was as a therapy is immaterial. The appearance of a financial conflict of interest should have been reported to The Lancet, the referees, and to the press, in my opinion.
In his statement, Dr. Wakefield goes on to say:
It constituted no potential conflict until the patent was awarded.
Again, I strongly disagree. If the patent was a potential conflict of interest, so was the application. Both are a potential to profit.
Also, if the patent itself is a potential for profit, how can one justify the previous argument that the application was not a conflict since it was merely “for a possible therapy”? Again, if the language of the patent was a potential conflict due to the inclusion of the vaccine, the application was a potential conflict as well.
So, after that long introduction, what did Dr. Wakefield have to say to Matt Lauer?
Dr. Wakefield is back to denying that the invention was for a vaccine to prevent measles and is claiming it as merely a therapeutic agent.
But as we have already seen above, this is not what the patent states. This isn’t even consistent with Dr. Wakfield’s own previous comments.
Here is the section where Matt Lauer of Dateline interviewed Brian Deer on the topic:
First impression: Matt Lauer’s team messed up with the statement that the vaccine was “for the elimination of MMR”. I heard that statement as though the purpose of the Wakefield vaccine was to eliminate the MMR as a vaccine. The wording of the first sentence of the patent application is:
The present invention relates to a new vaccine for the elimination of MMR and measles virus and to a pharmaceutical composition…
I read this as the vaccine for the elimination of the MMR viruses from someone with a persistent infection of one or more of measles/mumps/rubella, not as for the elimination of the MMR vaccine itself.
It is not well worded.
The statement from the patent application that most clearly shows that it covers the invention as a vaccine is claim 2. It is short, clear and direct to the point.
The composition according to claim 1 adapted for use as a vaccine for the prophylaxis of measles virus.
This is what Dateline should have used, in my opinion.
I think the segment below clearly shows that part of the intention of the invention was as a vaccine for the prevention of measles which is purported to be safer.
fragment of Dr. Wakefield's original patent application
Back to the interview, I think that Mr. Deer makes a key point in stressing that the patent application discussed the invention as a “safer” vaccine. This makes it more clearly a possible contender to replace the MMR vaccine as a product.
Brian Deer notes on his website:
A letter from his lawyers dated Jan 31 2005 said: “Dr Wakefield did not plan a rival vaccine.”
It is very difficult to ascertain intentions. At a very real level, what Dr. Wakefield planned is immaterial. The fact of the matter is that there was a possibility (however remote) that Dr. Wakefield could profit if the combination MMR vaccine were removed. The appearance (at least) of a potential conflict of interest was there and should have been disclosed in the paper and press conference, in my opinion.
The information I would like to see on this would be Dr. Wakefield’s lab books (or notes, as the case may be). In particular, he is reported to have applied his “transfer factor” on at least one child. Were there any tests performed (say, measles titers?) that could have been used to justify development as a vaccine? For example, measles titers?
It is also worth noting that as far as I can see, all of the patents on this potential vaccine have been abandoned. In other words, Dr. Wakefield and/or the Royal Free Hospital do not appear to have continuing financial interests in the proposed measles vaccine, or the IBD/autism therapy.
As a final word–I find it interesting that in one of the patents Dr. Wakefield states that that the autism prevalence is about 1%. This from a document dated 1998, 10 years ago. So much for that epidemic, eh?
If you are like me, when it comes to speech (or augmentative and alternative communication) devices, the image that comes to mind is often a big, dedicated device like a dynavox.
Even more, text-to-speech and icon based programs are available for laptops and, get this, the iPhone/iPod-touch.
Imagine a device that not only helps with communication, but can be surf the web and play games and videos and music and do even more. Imagine a device that has a “cool factor”. Imagine a device that fits in your pocket.
Can you imagine it? Well, it seems insurance companies can’t.
You see, if it can do something in addition to speech, it isn’t covered. If it hasn’t been approved yet, it isn’t isn’t covered. And, let’s face it, insurance companies aren’t that fast at approving new technology.
The funny thing is, this could save them money.
“We would not cover the iPhones and netbooks with speech-generating software capabilities because they are useful in the absence of an illness or injury,” said Peter Ashkenaz, a spokesman for the federal Centers for Medicare and Medicaid Services. Private insurers tend to follow the government’s lead in matters of coverage. Two years ago, iPhones and netbooks barely existed, so it may not be surprising that the industry has yet to consider their role as medical devices.
A dynavox system costs about $8,000. An system based on an iPod touch can be under $400 plus external speakers (I don’t think the speakers on the iPod touch would be loud enough if there is any background noise. But I could be wrong.)
But, remember, insurance companies aren’t paying for the iPod becuase it isn’t tested yet. That and they don’t like devices that do more than one thing. They dislike devices that do more than one task so much that they pay a lot extra ($8,000 vs. $500) and, get this, they turn off the extra features.
DynaVox, a leading maker of devices for the speech-impaired, has computers that start at $8,000 and run Windows, just like 90 percent of all PCs. To meet insurance rules, DynaVox disables the general computing tools. After the insurer pays, customers can pay $50 to DynaVox to reactivate the full functions.
This strikes me as bureaucracy getting in the way. Other devices, which would save the insurance company money, should be easy to test and get approved.
I just don’t get what the hold up is.
Thanks to a very cool reader who pointed me at this story.
Addendum:
This story is being picked up by a few other bloggers as well:
One of the strangest parts of the story of Dr. Wakefield’s research is the birthday party where blood was drawn from his child’s friends who were given five pounds each.
Dateline NBC included this in their recent story, A Dose of Controversy. Here are two clips from that show, spliced together:
The first thing that struck me was the explanation of the money. If I understand Dr. Wakefield correctly, he didn’t “pay” the children, they were “rewarded” at the end of the party. That makes it a different situation “in ethical terms”.
I’d like to have one of the kids at the party explain the ethical differences, as I am confused.
I guess if the kids gave the blood of their own free will, and only later the were “rewarded”…they didn’t know they would get money…in that case the money wasn’t an incentive or a coercion? Is that what is being said?
Again for those who’ve heard the story, you can put your hands over and you can take time out here, but this is again my son’s birthday party, 32 healthy controls. And you line them up – with parental informed consent, of course. They all get paid £5, which doesn’t translate into many dollars I’m afraid.
So, were they were paid? I thought we just heard that they were “rewarded”, which is different in an ethical sense.
And, what about that “at the end of the party” statement? Again, a quote attributed to Dr. Wakefield:
“One child, who’s my son’s best friend, Ollie, he put his arm out, very bold, had the tourniquet put on, and then went very pale and sort of … wait till next year. He was nine at the time, and his four year old sister came up, stuck her arm out, had the blood taken, took her five pounds and went off.
Is it important that the children were rewarded at the end of the party? My guess is that makes it less of a coercion. But, that little girl got her money right away, didn’t she?
I guess if she was the last child to have blood drawn, and this was the end of the party, this could fit in with Dr. Wakefield’s description of “end of the party.” Possible, I guess, but that is not how I saw this playing out when I first read that quote.
“And (NAME) burst into tears. Ruined his birthday party. But people said to me, Andrew, look, you know, you can’t do this, people, children won’t come back to you. [laughter]. I said you’re wrong, I said: ‘Listen, we live in a market economy. Next year they’ll want ten pounds!'”
I am having trouble figuring out how to reconcile “rewards” with “a market economy” and the children wanting a higher amount the next time.
I gather that at least part of the problem Dr. Wakefield is facing is that blood is not bought or sold in the UK (at least, there is a statement to this effect on Brian Deer’s website). As a U.S. citizen, I am used to the idea that blood is bought and sold. Paying people for blood is still a bit strange to me, but not unheard of. But from my perspective, I would have greater respect for Dr. Wakefield if he had just said (assuming it is true) that he had made a mistake.
Just in case Dr. Wakefield’s comments in print seem a bit too surreal to be true, Here is a video with a bit more of Dr. Wakefield discussing the birthday party:
note–I made a number of clarifications after this post was published.
Misinformationists love a vacuum. Unfortunately, Dr. Paul Offit left them a big opening by not disclosing how much his hospital, the Childrens Hospital of Philadelphia (CHOP), paid him as his share of the royalties from the sale of the rights to his rotavirus vaccine invention.
Dr. Offit invented a rotavirus vaccine, together with CHOP faculty members Dr. Stanley Plotkin and Dr. Fred Clark. This vaccine was commercialized as RotaTeq. CHOP is reported to have been paid $182M, with a net income of $153M.
From that, Doctors Offit, Plotkin and Clark would have been paid an inventor’s share.
In my opinion, it was sufficient for Dr. Offit to acknowledge that it was a significant amount of money.
Mr. Mark Blaxill and Mr. Dan Olmsted of the Age of Autism blog felt differently. They felt it necessary to put an number to Dr. Offit’s royalty payment from CHOP.
Dr. Offit and CHOP declined to respond to their request for information on this subject.
As a point of interest: CHOP didn’t respond to my request, made at that time, either.
In this information vacuum, Misters Blaxill and Olmsted used public information from a scattering of sources to estimate that Dr. Offit was payed between $29M and $55M.
They were off by about a factor of 10.
As noted in a recent post, I showed how one could easily make an accurate estimate of the royalty payment from that sale, and it was about $6M. Misters Olmsted and Blaxill, who spent a considerable amount of time scouring information from the University of Arkansas to the University of California missed the easily obtainable public information on the CHOP website.
Before I wrote that piece, I contacted Misters Blaxill and Olmsted with the correct information, even including a statement that Dr. Offit had acknowledged that the estimate I came up with was accurate. I was informed that a public statement was necessary by Dr. Offit.
I found this odd because on Sept. 9, a statement by Dr. Offit was reported.
In an email correspondence with David Brown August 18, 2009, Dr. Paul Offit writes:
David,
CHOP sold its patent for $182 million. This information was made publicly available and was published in the Philadelphia Inquirer at the time. The inventors, Fred Clark, Stan Plotkin, and me split 10 percent of that three ways. This means that we each received about $6 million. It was a ridiculous amont of money and certainly far more than any of us needs, but it is also a far cry from what has been claimed.
But the part that hurts the most is the continued claim that we did this for the money. I don’t know any scientist who does it for the money (you certainly don’t make much in salary). You do it because it’s fun and because you think you can contribute. And the reward for creating a vaccine was also never financial. The reward was watching this vaccine dramatically reduce the incidence of rotavirus hospitalizations in the US and now getting to watch the vaccine enter the developing world in countries like Mali, Bangladesh, Vietnam, Ghana, and Nicaragua. That’s why we did it.
It hurts to watch people slander me the way they do. They just don’t know me. Or any of us that work so hard to get a technology like the rotavirus vaccine to the countries where it will save the most lives.
Paul
Reprinted with permission from David Brown and Dr. Paul Offit.
The National Autism Association put out a press release last week that was an amazing piece of work. Just not in a good way.
I was not the first to comment on it. Below is a post from the Countering Age of Autism blog that I asked to rerun here.
So, with permission:
On the 8th, NAA sent out a press release rehashing the same misinformation that AoA habitually runs (it’s almost like they got it right from them and Wakefield. They probably did). AoA picked it up and ran with it, and I spent a fair portion of my day trying to figure out who NAA was as well as mount an adequate rebuttal. I don’t know that it’s an adequate rebuttal, but it is what I can do.
I appreciate the researchers who work tirelessly in labs trying to figure out ways to save lives. I admire the diligence and commitment it takes to work for over two decades on one vaccine because you believe in it that strongly. Now, I don’t reach the level of adoring fan like Wakefield’s groupies apparently do (if you saw the Friday morning piece on the Today show before the Sunday Dateline, you know what I’m talking about), but I’m not a groupie kind of gal. Maybe those women are. My point is, this isn’t blind adoration speaking. I’ve read Dr. Offit’s books, all of them, because I wanted to know more about vaccines (read those first), and I read Autism’s False Prophets, as well, because I wanted to see what he’d found out.
For most of my son’s (who will be 20 this year) life, I have been focused on HIM. I homeschooled him for ten years, I spent the years before that often all day in the school system with him. He was the center of my world as I worked with him to help him. I didn’t join support groups; I didn’t talk to a lot of parents with autistic children. My husband and I labored alone for the most part. I wasn’t desperate; I was determined. I read everything I could on autism, mostly the science because I am so not into the woo. If it was woo, I stayed away from it. Until March of this year when I realized how much was out there.
Why did I start looking, now, after all these years? My daughters are on the spectrum as well. They are 12 and 14 years younger than their brother and it seemed like I needed to see what was out there. Especially since I have students who ask about vaccines and autism. I delved deep into the science of it, and then into the woo. Not all the woo, mostly the easy access free stuff at Huff and AoA and like autism organizations. Gods, but there is a frakload of woo out there. And really nasty behavior on the part of the woo-ites. Like the threats that Dr. Offit receives. Not acceptable behavior period.
So, when this stuff hit, I emailed Dr Offit to ask if he’d like to rebut this latest round of trash talk. And, thankfully, he did.
And here is the email that Countering Age of Autism posted:
Run with the permission of Dr. Offit:
Dear Kim,
Thanks for the support. At some point those who believe that vaccines cause autism will realize that I’m not their problem. The data are their problem. But I guess, absent supportive data, it’s easier and more satifying to attack me (I would also like to point out that I didn’t do any of these studies that exonerated vaccines as a cause of autism; I just explain them to the media).
Although it might sound crazy, I take some solace in the fact that those who oppose vaccines continue to get the facts wrong. It’s somewhat reassuring to know that they hate me for the wrong reasons. And the Huffington Post blog by James Moore, a well-respected journalist, is completely off the mark. I would have expected more.
1) I am not a paid consultant to Merck.
2) I never “voted myself rich” while I was on the ACIP. RotaTeq came up for a vote in 2006, three years after I was no longer a voting member. And even if I were a member, I wouldn’t have been allowed to vote. Further, I consistently declared my potential conflict. Although some people may find this hard to believe, I’m actually proud to be the co-inventor of the rotavirus vaccine and was more than happy to declare this at the beginning of every meeting.
3) What (the hell) does being the co-inventor of a vaccine have to do with standing up for the science of vaccine safety. It certainly doesn’t affect my financial position one way or the other. I do it because I think that children are getting hurt by all of this (the same reason I went into pediatrics and worked on vaccines). The logic of the anti-vaccine folks escapes me here. Let me see if I’ve got this right; I invent a vaccine that can save as many as 2,000 lives a day so that I can make money so that I can lie about vaccine safety so I can hurt children.
4) I do not receive salary support or laboratory support from the Hilleman endowed chair. Five percent of that endowment does go to support members of our division, but not me.
5) I never received one penny of the $350,000 claimed in the Burton report. All of that money went to Dr. Fred Clark. I was totally supported by grants to NIH.
I really do appreciate your support, Kim. Few seem to be willing to stand up for me. And it does occasionally get me down. But mostly it just makes me angrier and more determined to hang in there.
The press release has the header: “Doctor Who Made Millions Off MMR Manufacturer Does Not Tell Public of His Financial Relationship during NBC Dateline Broadcast”
The NAA state further,
Dr. Paul Offit of Children’s Hospital of Philadelphia (CHOP), who was interviewed for a Dateline NBC television special, failed to tell millions of viewers that while he was promoting MMR as safe he had also made tens of millions of dollars from selling another vaccine patent to Merck, which is the manufacturer of MMR.
Let’s take a look at what was actually said, shall we?
Matt Lauer states (about 1:45 into the video clip), “Dr. Offit is a target. Not just for supporting vaccine safety, but because he himself made millions of dollars for inventing a vaccine.”
Quite frankly, the NAA is lying. Matt Lauer knew that Dr. Offit invented a vaccine and made money from his vaccine and Matt Lauer informed his audience of this. My guess if pressed the NAA will likely hide behind the Merck connection. Yeah. Like Matt Lauer and his producer didn’t know that RotaTeq is sold by Merck. (if so, that Merck logo on the RotaTeq box should have been a big clue, don’t you think?)
A minor point: Dr. Offit did not sell a vaccine patent to Merck. He assigned the rights to his invention the Children’s Hospital of Philadelphia (CHOP), a standard arrangement for an academic or industry employee. CHOP then applied for and was granted patents. CHOP (not Dr. Offit) licensed the patent to Merck, and then sold the license rights to a third party for a lump sum. Out of that sum, CHOP payed Dr. Offit, Dr. Plotkin and Dr. Clark.
The NAA press release further states:
According to CHOP documents, Offit’s share of a royalty sale for the Rotateq vaccine to Merck is a minimum of $29 million and may approach $50 million.
This is wrong. This is wrong on two counts. First, there are no CHOP documents which state that Dr. Offit’s share of the sale of the patent rights for $29 to $50M. There can’t be documents that say this because Dr. Offit’s share was about 1/10 of this amount.
How did the NAA get such incorrect information? There is a blog post, written by Dan Olmsted and Mark Blaxill which estimates this based on information they gleaned from the CHOP website. Their misinformation has been spread far since that post.
The only problem is, Dan Olmsted and Mark Blaxill were wrong. They made some big (and easily avoided) mistakes.
First mistake is that they used the incorrect Patent and Intellectual Property Policy in their calculation. That agreement wasn’t in effect when Dr. Offit and his co-inventors invented what became RotaTeq. Even Misters Blaxill and Olmsted acknowledged this in their post.
payment to inventors was based on gross income, with 50 percent distribution on the first $250,000, 30 percent on the next $250,000, 15 percent on the next $4.5 million and 10 percent on the remainder.
The bulk of the payout was 10% of net income. Not 30% as Misters Blaxill and Olmsted assumed.
The second mistake is that Misters Olmsted and Blaxill neglected the fact that Dr. Offit shared the CHOP payment with his co-inventors, Dr. Stanley Plotkin and Dr. Fred Clark.
As part of its distinguished legacy of developing vaccines to improve the lives of children, Children’s Hospital investigators Paul Offit, M.D., chief, Division of Infectious Diseases; H Fred Clark, D.V.M., Ph.D.; Stanley Plotkin, M.D.; and The Wistar Institute developed RotaTeq®, the oral rotavirus vaccine that was licensed and further developed by Merck & Co. Inc.
Dr. Plotkin is the former chief of infectious diseases at CHOP, and Dr. Clark was a research professor of Pediatrics at CHOP. Both easily confirmed through the CHOP website.
It is unequivocal that CHOP considered Dr. Clark and Dr. Plotkin to be a part of the CHOP team. The Intellectual property policy (and all standard IP policies) divide the inventors’ share amongst all inventors.
Sorry to go into such detail, but I can not figure out why Misters Blaxill and Olmsted have not corrected their mistake. One commenter to their blog pointed out that Doctors Clark and Plotkin were CHOP faculty, only to have Mr. Blaxill respond that “…Offit would have received the entirety of the CHOP inventor’s share”. I’d be interested what Mr. Blaxill based that statement upon.
CHOP is reported to have sold their rights to RotaTeq for $182M. Using the correct information, this leads to an estimated payout of about $6M. (Note, Mr. Blaxill and Mr. Olmsted report that the net income to CHOP was $153M. This would lead to about $5M payment for each inventor).
Using the correct CHOP policy, one can calculate (based on $182M):
Inventor share
50% of first $250k is $125,000
30% of the next $250k is $75,000
15% of the next $4.5M is is $675,000
10% of the remainder ($176,750,000) is $17,675,000
Total inventor share $18,550,000
This is split amongst the three inventors, leading to:
each inventor getting $6,183,333
I have confirmed that this is is an accurate estimate with Dr. Offit.
I post this calculation not as an estimate, but as a demonstration that the accurate amount could have been calculated by Misters Olmsted and Blaxill with publicly available information at the time they did their blog post Misters Blaxill and Olmsted took great efforts to find information about the inventor policies at multiple other institutions–much more effort than was required to find the accurate information on CHOP’s own website.
$6M is a lot of money, don’t get me wrong. Dr. Offit has acknowledged this in his statements. But, it is much lower than the estimate that Mark Blaxill and Dan Olmsted have publicized. The honorable thing for these two gentlemen to do now is to correct their mistake.
The real honorable thing to do is to not only correct their error, but to correct the error wherever it has propagated.
What is more important than the amount of the sale is the fact that CHOP sold its interest in the patent. Why is that important? Because that means that the amount of money CHOP can make from this patent will be unaffected by just about anything Dr. Offit does or say.
But, I’ve strayed a bit on this post, away from the NAA. The source of the misinformation is the Age of Autism blog and Misters Blaxill and Olmsted. Perhaps the NAA could use the argument that they didn’t create the misinformation, they were just passing it along? Except that the NAA sponsors the Age of Autism blog.
Back to the rest of the press release. It is an amazing piece of work. I found it especially odd when the NAA interview themselves and make it sound like news. They don’t try to hide it, they give quotes from Wendy Founier and Jim Moody…and then list themselves as the contact people for the press release.
They also interview Dr. Wakefield, who calls Dr. Offit “disingenuous” at the beginning of the paragraph, and finishes the paragraph showing concern for how people like Dr. Offit might impact the integrity of the swine flu vaccine.
Anyone detect the irony there? Dr. Wakefield (and the NAA) are so concerned about the swine flu vaccine program that they worry about Dr. Offit impacting the integrity of the program?
Talk about disingenuous.
The press release repeats one of the stranger of the accusations against Dr. Offit–the claim that he does not treat patients with autism:
Beyond Offit’s financial conflicts, autism advocates are also dismayed about the physician’s credibility on speaking about autism in general, as he does not treat patients with autism.
Unless the NAA wants to state that autistics in Philadelphia do not get infectious diseases, it is pretty certain that Dr. Offit has treated a number of autistics in his long career.
To cap this all off, the Age of Autism blog, sponsored by the NAA, ran a post advertising the NAA press release. However, instead of calling it what it is, a press release, they framed it as being “reported by Reuters”.
Yeah. They tried to make it sound like news reporting by a major outlet rather than a press release.
David Brown, please read the article before making incorrect statements. The payment to CHOP was $182 million (Wistar received a separate and earlier $45 million dollar payment). From this, Offit would have received the entirety of the CHOP inventor’s share. Benchmarks show the inventor’s distribution can range from 15-35% of royalty income, with the current CHOP policy set at 30% (a share we didn’t feature in our calculations because it is a new standard and may not have been the relevant one for Offit’s distribution). In other words, our estimate is conservative and uses a percentage that is at the very low end of the relevant range.
I informed Mr. Blaxill and Mr. Olmsted ahead of publishing this post of this information, specifically that (a) Dr. Offit did not receive the entirety of the CHOP payout and that (b) their calculation of the CHOP inventors’ share was incorrect and not even a conservative estimate. I included links they could use to confirm the information. I encouraged them to make the correction. Mr. Blaxill and Mr. Olmsted have declined.
In preparation for the workshop, each of the five workshop panels will be holding pre-workshop planning conference calls from September 14, 2009 to September 25, 2009. These phone calls will be open to the public via conference call lines. Members of the public who call-in will be able to listen, but will not be heard.
The Contact Person for this meeting is:
Ms. Lina Perez
Office of Autism Research Coordination
National Institute of Mental Health, NIH
6001 Executive Boulevard, NSC
Room 8200
Rockville, MD 20852
Phone: 301-443-6040
IACCPublicInquiries@mail.nih.gov
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