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.

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11 Responses to “Yet another look at CBS's view of Offit's COI's”

  1. isles August 2, 2008 at 07:54 #

    Sullivan, you are clearly qualified to be Sports Editor because you hit that one out of the park.

    It’s sad that some seem to take denigration of fine researchers with humanitarian motivations as a different kind of sport.

  2. Ringside Seat August 2, 2008 at 10:18 #

    With what the anti-vaxxers have been up to, it’s quite vital for them to denigrate people such as Offit. It’s the only way they can get up in the morning and not reconize themselves for the gang of crooks and quacks and idiots that they are.

  3. Schwartz August 2, 2008 at 18:13 #

    “What Dr. Offit (and his co-inventors) proabably “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.”

    It’s ironic that you’re using the term “probably”. That was one of the main points of the report. You don’t actually know any details about what the financial conflict of interest is, you just know it actually exists.

    That seems to fall under the definition of “undeclared details”. That also falls under Orac’s definition of “less” information about the conflict of interest. All of these facts fall right in line with the report.

    1) We have experts being called independent, experts who influence billions of dollars of health care spending
    2) We know they have a conflict of interest despite being in positions of influence
    3) They don’t declare the details about their conflicts even in some cases when regulations require it

    Nothing you wrote here changes those facts.

  4. Sullivan August 2, 2008 at 18:41 #

    It’s ironic that you’re using the term “probably”. That was one of the main points of the report. You don’t actually know any details about what the financial conflict of interest is, you just know it actually exists.

    Thanks for catching that. I didn’t update it after my email to Dr. Offit.

    My statement was correct. I didn’t need the word “probably”.

    Would you like me to edit/delete your comment since it is inaccurate and based on a false assumption?

  5. Sullivan August 2, 2008 at 18:56 #

    Would you like to stay on this subject? I’ve heard your unconvincing arguments elsewhere, and I’m not going to let this discussion get dragged down.

    You are aware that Dr. Offit now has no financial COI invovling the discussion of vaccines? So, his comments about autism and vaccination are not conflicted?

    His book, Autism’s False Prophets, is being published and will be publicized at at time when Dr. Offit can not benefit financiall from it.

    He’s even donating the royalties from the book. Think about that–the time put into the book is essentially a loss for him since he could have applied that to a profitable venture.

    So, you have one of the world’s most respected vaccine researchers using his expertise to discuss a major problem in the autism community–at a personal financial loss to himself.

    For those who are actually thinking this through, it is a tough battle to attack Dr. Offit.

    Rather than fight him on the science and facts, they are working on throwing mud. Tells a lot.

  6. Kev August 2, 2008 at 21:15 #

    _”It’s ironic that you’re using the term “probably”.”_

    Schwarz, you just tried to make a point with me where you said ‘I would guess’…come on feller, its gotta be one thing or the other.

  7. Sullivan August 3, 2008 at 00:22 #

    Further–Scwhartz get’s it wrong in the importance of the word “probably”.

    the key point is not whether Dr. Offit has an agreement with his institution (he does). The key point is the fact that the royalties have been sold–by whoever owns them.

    Either way–if Dr. Offit had direct control of the royalties or not–the fact is, Whatever Dr. Offit says from here on out doesn’t affect his royalties on RotaTeq.

    That COI is gone.

    I would add that since he continues to talk about autism issues even though it can’t affect his bottom line tells us pretty clearly that his activities in autism in previous years were likely not motivated by profit.

    The argument was weak to begin with. Now it is just plain sad.

  8. Schwartz August 4, 2008 at 03:50 #

    Sullivan,

    If the details of Dr. Offits agreement are public I would appreciate the link. Otherwise, the details are not public.

    Is Dr. Offit acting as a consultant for Merck? Does Dr. Offit currently have a share in the licensing fees of the Rotateq Vaccine? If he has either, then he is in a position of conflict of interest when discussing the topic of vaccines.

    If he just sold his share, then he had a conflict of interest up until his share was sold. We already know he has historically violated conflict of interest guidelines.

    Kev,

    The irony is that by your definition, you felt that disclosure was the most important aspect of conflict of interest. By originally using the word Probably, and later this quote: “I’m not going to downplay the likelihood that Dr. Offit made money off of the vaccine patents. “, it is pretty clear that you don’t know the extent of the conflict of interest, yet you are arguing that everything is perfectly satisfactory.

    That is where the irony lies. Not the use of the term itself, but the dissonance of the arguments.

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

    That’s a blatent misquote if I ever read one. Especially when you quote it correct before.

    As for your argument that “independent” universities are immune from Donating Pharma fund influence, I suggest you do a little research into that matter. There are enough problems with that model to write a whole article about it. I suppose you believe the peer-reviewed journals are immune from industry influence despite their reliance on advertising revenue as well?

  9. Sullivan August 4, 2008 at 06:14 #

    Schwartz,

    you are missing big points again. Big points

    If he just sold his share, then he had a conflict of interest up until his share was sold. We already know he has historically violated conflict of interest guidelines.

    Dr. Offit worked for institutions (Wistar and Chop) while doing his research. He sold his intellectual property to them when he accepted the positions. That’s pretty much standard practice in all research/development (not just medicine).

    If I see another post misunderstanding that, it will be deleted.

    Wistar and CHOP sold their remaining rights to a third party recently. Just a little digging and you will find that Wistar sold partial rights years ago.

    Is it public? The patents shows transfers are ongoing (dated June 2008).

    The rest of your comment is nonsense. Sorry to put it so bluntly, but it is nonsense. I used the word “probably” in a draft and didn’t change it after getting the facts confirmed.

    Sorry that tripped you up. Redefining “where the irony lies” is a bit silly at this point. In the past you were pretty good at admitting a mistake. It served you well then, it would have helped this time.

    Your whole reliance on the word “probably” is either misunderstanding or misdirection anyway–see my above comment.

    http://leftbrainrightbrain.co.uk/?p=1022#comment-52230

    Now into the “blatant misquote”. I’d have given you points for that if you brought it up in an earlier response. However, in the “oops, that was a fact, not a probably” response, it doesn’t carry as much weight.

    Would you like to take a stab at the actual point of this post–the fact that the COI’s are now over? You’ve gone off topic enough for this post.

  10. Schwartz August 4, 2008 at 16:14 #

    Sullivan,

    “The rest of your comment is nonsense. Sorry to put it so bluntly, but it is nonsense. I used the word “probably” in a draft and didn’t change it after getting the facts confirmed.”

    Don’t be sorry, my argument isn’t nonsense, so I’ll try to clarify it again. If you read your post carefully, we are quite far from the full disclosure of Dr. Offits conflicts of interest. Removal of the word “probably” still doesn’t give us full disclosure, it just isn’t as good an example of the unknowns. On the topic of full disclosure, we’re no further ahead than before you wrote the article since there are no new public documents that provide full disclosure. The use of “Probably” is not the only place you couched your argument with conditional statements as I pointed out above.

    My point is quite simple: Dr. Offit has not fully disclosed publically the details of his conflicts of interest today or in the past. You have not provided any additional public details bringing us to full disclosure either.

    Kev’s article clearly states that he only considers undeclared conflicts of interest an issue.

    Given that Dr. Offit has not provided full disclosure, it should be considered an issue.

    “Redefining “where the irony lies” is a bit silly at this point. In the past you were pretty good at admitting a mistake. It served you well then, it would have helped this time.”

    I would admit a mistake if there was one. The irony still exists as I pointed out. Originally, I picked the first instance of conditional clauses to point out the irony. You corrected your entry, and I have since clarified and illustrated that the irony still exists.

    “Now into the “blatant misquote”. I’d have given you points for that if you brought it up in an earlier response. However, in the “oops, that was a fact, not a probably” response, it doesn’t carry as much weight.”

    You can choose to keep any misquotes you want in your article, I’m sure that adds to the credibility of an article complaining about accuracy in another journalist’s work (irony meter again). I didn’t realize misquotes are only a problem depending on the time of day they’re pointed out.

    “Would you like to take a stab at the actual point of this post—the fact that the COI’s are now over? You’ve gone off topic enough for this post.”

    Documents about WISTAR and CHOP don’t provide full disclosure on Dr. Offit’s interests. If there were any conditional terms in the contract of sale, then a conflict of interest may still very well exist even if money has changed hands. This happens all the time in industry. Companies often don’t put sales on their books until years later, when conditional clauses have been met. Payment terms can also be conditional, so we don’t have anything near full disclosure of Dr. Offit’s interests.

    Your casual dismissal of any possible influence from the Pharmaceutical donations to medical schools is not consistent with peer-reviewed literature in which Conflict of Interest in medical schools and universities is indeed a topic of concern in very recent times.

    If there is no further conflict of interest at all, then why has Dr. Offit not written an official letter to CBS pointing that out? It is interesting that the only official letter (from VFV) doesn’t actually address any specific points in the article while calling for a retraction. Compare this to Dr. Offits’ op-ed piece to the NYT that was littered with inaccuracy. Dr. Poling responded officially, publically, and specifically addressed the inaccuracies with actual information. It sounds like Dr. Offit had the opportunity to provide input, and declined. Given his writing prowess, I’m surprised he has chosen not to correct these misconceptions himself. It’s great that you’ve pointed out misunderstandings regarding the workings of patents in medical research, but without full disclosure, we can’t really confirm your assertion that he has no conflicts of interest.

Trackbacks/Pingbacks

  1. Autism Blog - Conflicts, then and now | Left Brain/Right Brain - September 3, 2008

    [...] have been settled and Dr. Offit’s tenure as a consultant to Merck has ended. Basically, it’s as we’ve discussed before: Dr. Offit no longer has any financial conflicts of interest in discussing [...]

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