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Inside Autism: Dr. Paul Offit responds

5 Aug

I figured I was pretty well done with the Paul Offit/CBS story.  But, I think anyone who has been following these posts would like to read Dr. Paul Offit responds, on the Inside Autism blog.

I’m glad someone else approached him for a discussion of this.

I’ll pull just a couple of points out:

Dr. Offit explains that he did supply CBS news with information including

* The sources and amounts of every grant he has received since 1980;

* The details of his relationship, and Children’s Hospital of Philadelphia’s relationship, with pharmaceutical company Merck. Offit co-invented a Rotavirus vaccine that is manufactured by Merck. Children’s Hospital of Philadelphia, Offit said, holds the patent.

* The details of every talk he has given for the past three years. CBS asked for the past 28 years, but Offit said he hasn’t saved that information.

He notes that a followup email from Sharyl Attkisson stated:

You’re clearly hiding something and you need to be straightforward, the public has a right to know who its advisers are

Nope. No bias there.

I can fully understand why Dr. Offit declined the interview.

The story closes with a statement about why he keeps talking about vaccines:

“You’re asking me the question I spend the most time thinking about: Should I still be doing this? I’m just going to do it until people stop listening. It’s the thing I struggle with the most, and I think it’s unfair.

Well, if he looks at the last week of blogging here, he will see that at least this person is listening.

I hope people are listening in September.

Fax to Katie Couric

4 Aug

As you may have guessed if you’ve been reading this blog lately, the recent CBS story on the independence of vaccine supporters bothered me.

It bothers me that a news organization I grew up with would act the way they have.

Today I sent a fax to Katie Couric at CBS.  The text is below:

August 4, 2008

Katie Couric, Managing Editor
CBS Television Network
524 West 57th Street
6th Floor
New York, NY 10019-2902

VIA FACSIMILE

Dear Ms. Couric,

It is with great dismay that I, a parent of a young child with autism, have watched the ongoing series on autism by Sharyl Attkisson. This series’s angle was illustrated in her interview with Dr. Healy, which was tainted by the unfounded statement, “There is a completely expressed concern that they don’t want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people.” I feel a good journalist would have asked for Dr. Healy to support this statement. Given the stakes involved, that would be the minimum required before airing it.

I expect you will not be surprised that I also have concerns over the recent piece questioning the independence of vocal supporters of vaccines. In particular, the part discussing Dr. Paul Offit was lacking in facts and in real analysis of those facts .

A) The statement by Dr. Offit that a child can theoretically handle 10,000 vaccines at once was made, but with no discussion. This is often quoted out of context by Dr. Offit’s detractors, intended to create the impression that his views are somehow extreme. Nothing could be farther from the truth: the statement shows the minimal demands that vaccines make on the immune system, even that of a young infant. In fact, given the number of immunological challenges in the human environment, children do receive the equivalent of thousands of vaccines every day. Dr. Offit’s statement is also not a mere opinion: it is based on calculations he has performed and published in the peer reviewed literature. No one has published a paper showing this calculation to be false or exaggerated in any way.

Given that, I would ask that if CBS wishes to present this statement in the future, they either discuss it in context or, should CBS disagree with Dr. Offit’s analysis, present a reasoned discussion of why they disagree.

B) The statement that Dr. Offit holds an endowed chair joint with the University of Pennsylvania School of Medicine and the Children’s Hospital of Philidelphia (CHOP) was presented as a potential conflict of interest, because much of the funding for this chair came from Merck. (Unreported by Ms. Attkisson was the fact that CHOP supplied the rest of the endowment.) As stated, it implies that this is some form of a grant, giving Merck leverage over Dr. Offit. Those of us familiar with academia know that the opposite is true: the endowment is a gift to the University, not to the individual who holds the chair, and the donor (Merck in this case) retains no control over the disbursement of funds. The recipient of the chair is chosen in a competitive process. Thus, the holder of the chair is fully independent – both of any obligation to the donor and of the continuing obligation to cover one’s salary with research grants. Ms. Attkisson’s piece implied exactly the opposite.

C) It was noted that future royalties from Dr. Offit’s patents have been sold for $182 million. First, it is worth noting that Dr. Offit and his co-inventors do not “hold” the patents, but assigned the rights to their institutions: the Wistar Institute and the Children’s Hospital of Philadelphia. These are the groups which have negotiated the sale of future royalties. Second, it is worth noting that this sale of future royalties means that whatever statements Dr. Offit makes about vaccines can no longer have even the possible influence on his finances implied by the story.

I will not discount the fact that Dr. Offit likely has benefited financially from his efforts to produce a vaccine. Frankly, I hope he did. His vaccine saves lives throughout the world. But, the point for this discussion is that the value of these financial gains has already been determined.

Of note is the fact that no other patents or patent applications are published at present. His laboratory is closed down. Thus, there is no future vaccine which could present a possible conflict of interest for Dr. Offit.

Given these facts, what we have is a scientist who has over 25 years’ experience researching vaccines and infectious diseases, and has no financial conflicts of interest in the present or future. Isn’t this exactly what we want in a spokesperson?

This is a key point. The reason why Dr. Offit is being targeted in some quarters is that he has a book about to be published, “Autism’s False Prophets: Bad Science, Risky Medicine, and the Search for a Cure.” Not only is it obvious that non-mainstream autism organizations like Generation Rescue would like to defuse the impact of this book before it hits, but leaders of the organization have baldly stated their plans to attempt to discredit Dr. Offit and the findings revealed in the book. The fact that Dr. Offit is willing to face their attacks, with no prospect of personal gain, bespeaks a purity of intent, not only in this venture, but also in his past statements about vaccines.

The recent incident whereby a fax from Lisa Randall of Voices For Vaccines was given within hours to Generation Rescue, an organization outside of CBS, begs the question: what is the connection between Ms. Attkisson or members of the CBS News staff and Generation Rescue? This is a serious question which I hope CBS News publicly addresses.

It also seems appropriate to ask in closing: Does Ms. Attkisson or other members of the CBS news staff involved with these stories have any conflicts of interest, real or potential, in discussing autism and/or vaccine injury? Again, I would hope that CBS News would publicly address this.

CBS made a highly unprofessional decision in sharing the fax from Ms. Randall with Generation Rescue, an organization which insults, smears and attempts to intimidate those with whom they disagree. This is unfortunate, because I would like to demonstrate the fact that I have no ties whatsoever to the pharmaceutical industry by giving my full identity. Instead, I will sign simply:

Sullivan
Autism Parent
LeftBrainRightBrain.co.uk
SullivansJourney@gmail.com

Sharyl Attkisson is slowly catching up to Neurodiversity.com and Arthur Allen

2 Aug

Sharyl Attkisson has posted yet another in her series on vaccines in autism.

It’s the first time we know of that the government has “conceded” an autism case in vaccine court. But CBS News has learned the government has previously been court-ordered to pay on other vaccine injury cases in which a child ended up with damage including autism or autistic symptoms.

And then discusses the case involving a child with Tuberous Sclerosis (TS).

Sharyl Attkisson would do well to read (if she hasn’t already) the Neurodiversity.com blog where previous cases. In specific, the post “a not so hidden history“. One of the cases there, Suel v. HHS involves a child with TS and autistic symptoms. While the case Ms. Attkisson is discussing appears to be a different one (from 1986), it uses the same expert witness (Gomez).

Will Ms. Attkisson now “discover” the other cases of compensated vaccine injury involving people with autism or autistic symptoms?

Maybe in her extensive research she missed Arthur Allen’s piece on the same subject? He cleverly hid it under the title “Recent Vaccine-Autism Award Not the First“.

Yet another look at CBS's view of Offit's COI's

2 Aug

Paul Offit has been much in the news and blogOsphere lately (Say, here , here and here. Dr. Offit is a vaccine researcher and vocal supporter of vaccines. This makes him a target amongst some groups, leading to a recent example of the “investigative reporting” that CBS news’ Sheryl Attkisson brings to the public.

A big question comes up as to Dr. Offit’s conflicts of interest. Ms. Attkisson’s story brings up a few. Let’s take a look. First we have the fact that Dr. Offit holds an endowed chair:

Offit holds in a $1.5 million dollar research chair at Children’s Hospital, funded by Merck. He holds the patent on an anti-diarrhea vaccine he developed with Merck, Rotateq, which has prevented thousands of hospitalizations.

OK, simple fact check: the endowed chair is $2M, with $500,000 seed money put in by Children’s Hospital of Philidelphia and the University of Pennsylvania.

Not many people have reason to know the details of what an endowed chair is. If I didn’t know better, the above quote makes it sound like the $1.5M from Merck is something akin to a grant, giving Merck some leverage on Dr. Offit. Actually, chair endowments are basically trust funds. In this case, Merck donated $1.5M to CHOP and Penn, who manage the money independent of Merck. These institutions use the proceeds of the endowment to pay for salary and research funds for the chair holder. CHOP and Penn decide who get the chair after Dr. Offit leaves or retires. It is not “His” chair, but the institutions’.

Remember that bit about “research funds”? This is money that allows a the chair holder (Dr. Offit in this case) to do independent research. He doesn’t have to apply for grants, but has a constant supply of money. Merck doesn’t have a say in how he spends those funds.

Isn’t that a good thing? Independent researchers, not beholden to funding agencies?

So, the endowed chair is not a conflict of interest at all.

What other conflict of interest did Ms. Attkisson “unearth”? Well, she noted in the above quote that Dr. Offit is a co-inventor of a patent on a Rotavirus vaccine. She goes on to state:

And future royalties for the vaccine were just sold for $182 million cash. Dr. Offit’s share of vaccine profits? Unknown.

OK, I am going to be picky on details again. Yep, I make a lot of mistakes too, but I gotta get this one out. Dr. Offit doesn’t “hold” a patent on the vaccine. He is an “inventor”. He “assigned” the rights to:

The Wistar Institute of Anatomy and Biology, Philadelphia, PA
The Children’s Hospital of Philadelphia, Philadelphia, PA

I’ll also point out that he is listed as an inventor on about 24 patents worldwide, with about 10 on Rotavirus. Of those, there are multiple US Patents. (I’ll note that Dr. Offit does not list all his patents on his resume.)

I’m sure I’ve made the “holds patent” mistake a lot. I would venture to guess that you might even find the mistake in statements by Dr. Offit. In general, I wouldn’t think “holds patent” is a big deal. He may discuss it as “his” patent because the ideas are “his” and his co-inventors. But, in the financial sense, the patent belongs to the assignee. Initially, this was CHOP and the Wistar Institute. So, why bring it up here? Because, (a) a news reporter should be more accurate and (b) I think the language is important in this specific case.

What Dr. Offit (and his co-inventors) proabably [edit–no probably about it, hat-tip to Scwhartz for catching this] “hold” is an agreement with the assignees (CHOP and the Wistar Institute) for some share of license fees or for bonuses based on the successful licensing of the patent.

That’s how research works. The company or institution takes the risks that a researcher’s work will never pan out. They pay salary, they pay the fees to file patents. Typically, researchers’ shares in license fees are determined before research is completed, often when the researcher is hired.

But, that doesn’t sound as interesting as “He holds a patent licensed for $182 million”, does it?

I’m not going to downplay the likelihood that Dr. Offit made money off of the vaccine patents. I hope he did. But, if he were in it for the money, there were a lot of things he could have done to make more in his career once it became obvious that RotaTeq was likely to succeed. Talking about the lack of science behind the autism/vaccine connection isn’t one of them.

And that’s what this is all about, isn’t it? The implication that Dr. Offit is out for the money. People want to make the public think that he speaks out on vaccine safety because he will get more money.

Well, recall that the future royalties on RotaTeq have been sold. What does that tell us about Dr. Offit’s conflicts of interest? It tells us that the financial COI on RotaTeq is basically over!

Consider the world view of those who claim that Dr. Offit speaks out on vaccine safety to line his own pockets. How much money will Dr. Offit make on RotaTeq if he speaks out on autism issues? How much will he make on RotaTeq if he stops speaking out?

They are the same amount.

So, CBS had two potential COI’s on Dr. Offit: the endowed chair and the RotaTeq royalties. Neither of which is an active COI at this time and into the future.

So, what’s missing from the CBS example of “investigative journalism”? How about a discussion of Dr. Offit’s research grants? Where did the money come to support the research into the vaccine? We all know that CBS must have looked into that. Why nothing in the story? Could it be that there is no story there? Uh huh. The National Institutes of Health funded Dr. Offit’s research on rotavirus. Merck took over the development and testing phase of the vaccine in 1991, but the actual creation of the vaccine occurred without industry funding.

So, did Merck do “payback” and fund Dr. Offit’s research since then? (Again, CBS had to have considered that). Not that I can see. No Merck funded projects are listed in his resume with him as principal investigator.

Quite frankly, I am surprised by how few industry funded research projects Dr. Offit has been principal investigator on. Given his expertise, I would have expected much more industry funding. Much more.

That doesn’t make a good story though, does it?

So, how does Dr. Offit act when a COI is in play? Oddly, this discussion recently occurred on this blog.

Dr. Offit was a member of the Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention from 1998 to 2003. During this time he had to vote on a competitor’s rotavirus vaccine (RotaShield). (People seem to have a habit of confusing RotaShield with Dr. Offit (and team’s) RotaTeq)

So, when RotaShield, the competitor’s vaccine, came up for vote, what Did Dr. Offit say? He voted to include it in the schedule. It’s hard to spin that as something that would benefit Dr. Offit, as it clearly meant that the marketability of his own vaccine was reduced.

Rotashield was found to potentially cause intussusception. The numbers affected were too small to detect in the trial, so this concern was raised after the vaccine was added to the schedule. the ACIP took a vote on whether to remove RotaShield from the schedule–a move that clearly had potential benefits for Dr. Offit, so he abstained.

I guess that didn’t fit in the CBS story either.

Why are we talking about Dr. Offit again? We can all speculate, but the good folks at the Age of Autism answer the question for us:

Paul Offit is quickly coming under suspicion for his pharma ties and losing his usefulness as a vaccine promoter in the press.
It’s a little hard to pretend that all you do is work at Children’s Hosp. of Philadelphia, when you’ve gotten coverage on CBS and in the
Wall Street Journal because of serious conflicts of interest. Offit’s new book,
“Autism’s False Prophets: Bad Science, Risky Medicine, and the Search for a Cure,” is due out this fall but I hardly think anyone will think of him as a credible independent expert.

Anne Dachel
Media editor

Yep, they realize that “Autism’s False Prophets” is soon to hit the shelves of bookstores. I wish I had a copy now, as it must be pretty scary to the Generation Rescue crowd since they are putting on such a big preemptive strike.

I’ve already asked my library to order a copy.

By the way, I love how everyone at Age of Autism is an editor

Sullivan
LeftBrain/RightBrain Antarctic Bureau, Sports Desk.

Stop the presses: Paul Offit's resume is WRONG!

1 Aug

If you check Dr. Offit’s resume, you will find that he list three patents:

Clark, HF., Offit, P., Plotkin, S.A. Rotavirus reassortant vaccine. United States Patent #5,626,851. Issued May 6, 1998.

Speaker, T.J., Clark, H.F., Moser, C.A., Offit, P.A., Campos, M., Frenchick. P.J. Aqueous-based encapsulation of a bovine herpes virus type-1 subunit vaccine. United States Patent #6,270,800. Issued August 7, 2001.

Clark HF, Speaker, T.J., Offit, P.A. Aqueous solvent encapsulation method, apparatus and microcapsules. United States Patent number 6,531,156. Issued March 11, 2003.

In preparing a post, I found that the above is not accurate. I feel I must note the mistakes. Yes, there are multiple mistakes. If you do a patent search for “vaccine” with “Offit” as the inventor, you get 24 patents and applications. I list them below:

ES2216242T3 ENCAPSULACION DE VACUNA SUBUNITARIA CONTRA EL VIRUS DEL HERPES BOVINO TIPO 1 EN BASE A UN DISOLVENTE ACUOSO.

PT0873752T ENCAPSULACAO COM BASE EM SOLVENTE AQUOSO DE UMA VACINA DE UMA SUBUNIDADE DO VIRUS DO HERPES BOVINO DE TIPO-1

DK0873752T3 Vandigt oplesningsmiddel-baseret indkapsling af vaccine af en bovint herpesvirus type-1-underenhed

EP0873752B1 Aqueous solvent based encapsulation of a bovine herpes virus type-1 subunit vaccine

US6531156 Aqueous solven encapsulation method, apparatus and microcapsules

CA2065847C ROTAVIRUS REASSORTANT VACCINE

US6290968 Rotavirus reassortant vaccine

US6270800 Aqueous solvent based encapsulation of a bovine herpes virus type-1 subunit vaccine

EP0873752A3 Aqueous solvent based encapsulation of a bovine herpes virus type-1 subunit vaccine

US6113910 Rotavirus reassortant vaccine

AU0713639B2 AQUEOUS SOLVENT BASED ENCAPSULATION OF A BOVINE HERPES VIRUS TYPE-1 SUBUNIT VACCINE

ZA9803327A AQUEOUS SOLVENT BASED ENCAPSULATION OF A BOVINE HERPES VIRUS TYPE-1 SUBUNIT VACCINE.

DK0493575T3 Vaccine af reassortant rotavirus

JP10316586A2 CAPSULATION OF BOVINE HERPES VIRUS TYPE-1 SUBUNIT VACCINE ON BASIS OF AQUEOUS SOLVENT

NZ0330251A BOVINE HERPES VIRUS TYPE-1 (BHV-1) SUBUNIT VACCINE IN AN AQUEOUS SOLVENT BASED ENCAPSULATION

AU6351198A1 AQUEOUS SOLVENT BASED ENCAPSULATION OF A BOVINE HERPES VIRUS TYPE-1 SUBUNIT VACCINE

EP0873752A2 Aqueous solvent based encapsulation of a bovine herpes virus type-1 subunit vaccine
CA2229430AA AQUEOUS SOLVENT BASED ENCAPSULATION OF BOVINE HERPES VIRUS TYPE-1 SUBUNIT VACCINE

EP0493575B1 ROTAVIRUS REASSORTANT VACCINE

US5750109 Rotavirus reassortant vaccine

US5626851 Rotavirus reassortant vaccine

GR3018262T3 Rotavirus reassortant vaccine.

EP0323708B1 Rotavirus reassortant vaccine

EP0493575A4 ROTAVIRUS REASSORTANT VACCINE

Why would someone leave all those patents off of a resume? A lot of these patents are international versions of US patents (Note the first two letters in each patent number US=United States, EP=European Patent, GR=Great Britain, etc.). Some of the US patents are “picture patents”. They are non-obvious variations, but similar to other, more fundamental patents.

Oh, yeah. There was another mistake. He lists patent #5,626,851 as Issued May 6, 1998. Actually, it was issued May 6, 1997. Obviously a part of some plot. I can’t tell how exactly it benefits him, but it must somehow. Just like the fact that he left patents off his resume, must be a plot. Nefarious.

Well, curiosity got the best of me. I emailed Dr. Offit to ask why these are missing from his resume. He responded that yes, indeed, they are “picture patents”, and that including them all seemed like resume padding.

There is a saying amongst old timers (in any field): “I’ve forgotten more about this subject than you will even know”. It appears that Dr. Offit has left more pertinent qualifications off his resume than his detractors (combined) will ever have.

How many of us have resumes so good that we can leave off 21 patents and cherry pick the really fundamental ones? How many of us can only list the invited talks we’ve given in the recent past (as Dr. Offit does)?

CBS news: can I have a job? I’ve “unearthed” more than you did. Oh, but it doesn’t fit with the “conflict of interest” theme, does it?

Sharyl Attkisson's long history of anti-vaccinationism

1 Aug

As blogged by Mike, Liz, Autism News Beat, Kristina and Orac, CBS reporter Sharyl Attkisson seems to the prime suspect in the matter of how a fax sent to CBS News by Voices for Vaccines turned up on the Age of Autism blog less than 1 day later.

This matters. Reporters are supposed to be independent. They are supposed to give a balanced view. The very act of forwarding this fax to Age of Autism simply confirms that someone at CBS News, mostly likely Ms Attkisson, is deeply affiliated with Age of Autism. This makes her conflicted and she is totally the wrong person to be investigating the autism/vaccine hypothesis.

I went looking to see what else I could find to support my opinion that Ms Attkisson is someone who is not a reporter, but someone presenting her opinion in the name of investigative news. I found plenty.

Take this ‘interview‘ with Rep. Dave Weldon about the Poling case. I put the word interview in single quotes because it really isn’t an interview, its more a series of questions to allow Weldon to trot out a series of inaccuracies supportive of the idea vaccines cause autism. This is the sort of journalist who would ask God ‘tell me God, do you believe in creationism?’ And then give God a five minute run to explain how he does.

She was also the CBS employee (it seems wrong to keep saying she is a reporter) who interviewed Bernadine Healy in which the former Philip Morris shill said we should re-examine the autism/vaccine idea.

Over on the ‘No Mercury’ website, there is a long list of videos of Ms Attkisson (35 in total, dating back to March 2002) of which all seem to be ‘investigations’ into vaccines and other pharma related activities.

This piece which relates some of the most common and mind-numbingly stupid antivax canards around is just about the clearest indication of her loyalties. Anyone who states the following is not impartial and should not be investigating this story:

Non-profits which dispel any vaccine/autism/ADD link have ties to vaccine makers.

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